advanced medical technologies http://blog.mediligence.com insights, perspectives and inside data from medtech market analysis at MedMarket Diligence, LLC Wed, 28 Sep 2016 15:09:58 +0000 en-US hourly 1 66423588 Coronary and Peripheral Vascular Dominate Global Cardiovascular Procedure Volumes http://blog.mediligence.com/2016/09/28/coronary-and-peripheral-vascular-dominate-global-cardiovascular-procedure-volumes/ Wed, 28 Sep 2016 15:09:58 +0000 http://blog.mediligence.com/?p=9704 Continue reading "Coronary and Peripheral Vascular Dominate Global Cardiovascular Procedure Volumes"]]>

In 2016, the cumulative worldwide volume of the cardiovascular device procedures is projected to approach 15.05 million surgical and transcatheter interventions. This will include:

  • roughly 4.73 million coronary revascularization procedures via CABG and PCI (or about 31.4% of the total),
  • close to 4 million percutaneous and surgical peripheral artery revascularization procedures (or 26.5% of the total);
  • about 2.12 million cardiac rhythm management procedures via implantable pulse generator placement and arrhythmia ablation (or 14.1% of the total);
  • over 1.65 million CVI, DVT, and PE targeting venous interventions (representing 11.0% of the total);
  • more than 992 thousand surgical and transcatheter heart defect repairs and valvular interventions (or 6.6% of the total);
  • close to 931 thousand acute stroke prophylaxis and treatment procedures (contributing 6.2% of the total);
  • over 374 thousand abdominal and thoracic aortic aneurysm endovascular and surgical repairs (or 2.5% of the total); and
  • almost 254 thousand placements of temporary and permanent mechanical cardiac support devices in bridge to recovery, bridge to transplant, and destination therapy indications (accounting for about 1.7% of total procedure volume).

screen-shot-2016-09-28-at-11-05-28-am

Source: Global Dynamics of Surgical and Interventional Cardiovascular Procedures, 2015-2022.

]]>
9704
Global and Regional Cardiovascular Surgical and Interventional Procedures Forecast; Reveals Cardio Tech Outlook http://blog.mediligence.com/2016/09/21/global-and-regional-cardiovascular-surgical-and-interventional-procedures-forecast-reveals-cardio-tech-outlook/ Thu, 22 Sep 2016 03:11:10 +0000 http://blog.mediligence.com/?p=9698 Continue reading "Global and Regional Cardiovascular Surgical and Interventional Procedures Forecast; Reveals Cardio Tech Outlook"]]> With few exceptions, cardiovascular technologies no longer command big premiums (like many other medtech sectors) and mature Western markets for cardio devices have already captured most of the readily available patient caseloads. The lines between different markets (device, drugs, materials) are blurring, while surgical specialists seek to slow the caseload migration to interventionalists. The epicenter of growth in utilization of advanced cardiovascular technologies and techniques is gradually shifting to emerging Asia-Pacific markets away from the increasingly stagnant U.S. and Western European marketplace. The latter reflects the sheer size of underserved patient caseloads, availability of funding, and increasing reliance on economical domestically reproduced sophisticated endovascular devices.

“In order to be successful, manufacturers, investors, healthcare providers, advisors, and others in cardiac surgery and endovascular fields need to understand the real dynamics and asymmetrical development pattern of different cardiovascular device markets in different geographies,” says Patrick Driscoll of MedMarket Diligence. “At the root of understanding the market is accurately and realistically gauging the current and future demand for, and likely usage of, specific medical and surgical technologies and procedures.”

MedMarket Diligence has published a comprehensive resource available to manufacturers, investors, and others with interest in cardiovascular technologies. “Global Dynamics of Surgical and Interventional Cardiovascular Procedures, 2015-2022,” is a worldwide competitive analysis and forecast of existing and emerging cardiovascular technologies and procedures coupled with identification and assessment of the most promising and sizable device markets.

The report covers surgical and interventional therapeutic procedures commonly used in the management of acute and chronic conditions affecting the myocardium and vascular system. The latter include ischemic heart disease (and its life threatening manifestations like AMI, cardiogenic shock, etc.); heart failure; structural heart disorders (valvular abnormalities and congenital heart defects); peripheral artery disease (and limb and life threatening critical limb ischemia); aortic disorders (AAA, TAA and aortic dissections); acute and chronic venous conditions (such as deep venous thrombosis, pulmonary embolism and chronic venous insufficiency); neurovascular pathologies associated with high risk of hemorrhagic and ischemic stroke (such as cerebral aneurysms and AVMs, and high-grade carotid/intracranial stenosis); and cardiac rhythm disorders (requiring correction with implantable pulse generators/IPG or arrhythmia ablation).

The report offers epidemiology and mortality data for the major cardiovascular conditions along with current assessment and projected procedural dynamics (2015 to 2022) for primary market geographies (e.g., United States, Largest Western European Countries, and Major Asian States) as well as the rest of the world.

Methodology. The MedMarket Diligence procedural assessments and forecasts are based on the systematic analysis of a multiplicity of sources including (but not limited to):

  • Latest and historic company SEC filings, corporate presentations, and interviews with product management and marketing staffers;

  • Data released by authoritative international institutions (such as OECD and WHO), and national healthcare authorities;

  • Statistical updates and clinical practice guidelines from professional medical associations (like AHA, ACC, European Society of Cardiology, Chinese, Indian, and Japanese Societies of Cardiology, etc.);

  • Specialty presentations at major professional conferences (e.g., TCT, AHA Scientific Sessions, EuroPCR, etc.);

  • Publications in major medical journals (JAMA, NEJM, British Medical Journal, Lancet, etc.) and specialty magazines (CathLab Digest, Endovascular Today, EPLab Digest, etc.);

  • Findings from relevant clinical trials;

  • Feedback from leading clinicians (end-users) in the field on device/procedure utilization trends and preferences; and

  • Policy papers by major medical insurance carriers on uses of particular surgical and interventional tools and techniques, their medical necessity and reimbursement.

Surgical and Interventional Procedures Covered:

  • Coronary artery bypass graft (CABG) surgery;

  • Coronary angioplasty and stenting;

  • Lower extremity arterial bypass surgery;

  • Percutaneous transluminal angioplasty (PTA) with and without bare metal and drug-eluting stenting;

  • Peripheral drug-coated balloon angioplasty;

  • Peripheral atherectomy;

  • Surgical and endovascular aortic aneurysm repair;

  • Vena cava filter placement;

  • Endovenous ablation;

  • Mechanical venous thrombectomy;

  • Venous angioplasty and stenting;

  • Carotid endarterectomy;

  • Carotid artery stenting;

  • Cerebral thrombectomy;

  • Cerebral aneurysm and AVM surgical clipping;

  • Cerebral aneurysm and AVM coiling & flow diversion;

 

  • Left Atrial Appendage Closure;

 

  • Heart valve repair and replacement surgery;

  • Transcatheter valve repair and replacement;

  • Congenital heart defect repair;

  • Percutaneous and surgical placement of temporary and permanent mechanical cardiac support devices;

  • Pacemaker implantation;

  • Implantable cardioverter defibrillator placement;

  • Cardiac resynchronization therapy device placement;

  • Standard SVT/VT ablation; and

  • Transcatheter AFib ablation

Report #C500, “Global Dynamics of Surgical and Interventional Cardiovascular Procedures, 2015-2022”, is described in full at link. The report may be purchased for download at link.

For information, contact Patrick Driscoll, +1.949.891.1753 or reports@mediligence.com.

 

]]>
9698
Medtech Fundings for September 2016 http://blog.mediligence.com/2016/09/15/medtech-fundings-for-september-2016/ Thu, 15 Sep 2016 20:09:52 +0000 http://blog.mediligence.com/?p=9690 Continue reading "Medtech Fundings for September 2016"]]> Fundings in medical technology stand at $900 million for the month, led by the $345 million private placement by Insulet Corp., followed by the $168 million funding of Intarcia Therapeutics, the $86 million IPO of iRhythm Technologies, and the $75 million IPO of Obalon Therapeutics.

Below are the top fundings for the month thus far. Revisit this post (and refresh your browser) through September to see updates.

For the complete list of September 2016 fundings, see link.

screen-shot-2016-09-26-at-10-54-28-am

Source: Compiled by MedMarket Diligence, LLC.

For a historical list of medtech fundings by month since 2009, see link.

]]>
9690
Wound management practice patterns, products by wound type http://blog.mediligence.com/2016/09/13/wound-management-practice-patterns-products-by-wound-type/ Tue, 13 Sep 2016 14:32:32 +0000 http://blog.mediligence.com/?p=9684 Continue reading "Wound management practice patterns, products by wound type"]]> From Report #S251, “Wound Management to 2024”.

Surgical wounds account for the vast majority of skin injuries. We estimate that there are approximately 100 million surgical incisions per year, growing at 3.1% CAGR, that require some wound management treatment. About 16 million operative procedures were performed in acute care hospitals in the USA. Approximately 80% of surgical incisions use some form of closure product: sutures, staples, and tapes. Many employ hemostasis products, and use fabric bandages and surgical dressings.

Surgical procedures generate a preponderance of acute wounds with uneventful healing and a lower number of chronic wounds, such as those generated by wound dehiscence or postoperative infection. Surgical wounds are most often closed by primary intention, where the two sides across the incision line are brought close and mechanically held together. Overall the severity and size of surgical wounds will continue to decrease as a result of the continuing trend toward minimally invasive surgery.

Surgical wounds that involve substantial tissue loss or may be infected are allowed to heal by secondary intention where the wound is left open under dressings and allowed to fill by granulation and close by epithelialization. Some surgical wounds may be closed through delayed primary intention where they are left open until such time as it is felt it is safe to suture or glue the wound closed.

Traumatic wounds occur at the rate of 50 million or more every year worldwide. They require cleansing and treatment with low-adherent dressings to cover the wound, prevent infection, and allow healing by primary intention. Lacerations are a specific type of trauma wound that are generally minor in nature and require cleansing and dressing for a shorter period. There are approximately 20 million lacerations a year as a result of cuts and grazes; they can usually be treated in the doctors’ surgery, outpatient medical center or hospital A&E departments.

Burn wounds can be divided into minor burns, medically treated, and hospitalized cases. Outpatient burn wounds are often treated at home, at the doctor’s surgery, or at outpatient clinics. As a result, a large number of these wounds never enter the formal health service system. According to the World Health Organization (WHO), globally about 11 million people are burned each year severely enough to require medical treatment. We estimate that approximately 3.5 million burns in this category do enter the outpatient health service system and receive some level of medical attention. In countries with more developed medical systems, these burns are treated using hydrogels and advanced wound care products, and they may even be treated with consumer-based products for wound healing.

Medically treated burn wounds usually receive more informed care to remove heat from the tissue, maintain hydration, and prevent infection. Advanced wound care products are used for these wounds. There are approximately 6.0 million burns such as this that are treated medically every year.

Hospitalized burn wounds are rarer and require more advanced and expensive care. These victims require significant care, nutrition, debridement, tissue grafting and often tissue engineering where available. They also require significant follow-up care and rehabilitation to mobilize new tissue, and physiotherapy to address changes in physiology. Growth rates within the burns categories are approximately 1.0% per annum.

Chronic wounds generally take longer to heal, and care is enormously variable, as is the time to heal. There are approximately 7.4 million pressure ulcers in the world that require treatment every year. Many chronic wounds around the world are treated sub-optimally with general wound care products designed to cover and absorb some exudates. The optimal treatment for these wounds is to receive advanced wound management products and appropriate care to address the underlying defect that has caused the chronic wound; in the case of pressure ulcers a number of advanced devices exist to reduce pressure for patients. There are approximately 9.7 million venous ulcers, and approximately 10.0 million diabetic ulcers in the world requiring treatment. Chronic wounds are growing in incidence due to the growing age of the population, and the growth is also due to increasing awareness and improved diagnosis. Growth rates for pressure and venous ulcers are 6%–7% in the developed world as a result of these factors.

Diabetic ulcers are growing more rapidly due mainly to increased incidence of both Type I and maturity-onset diabetes in the developed countries around the world. The prevalence of diabetic ulcers is rising at 9% annually. Every year 5% of diabetics develop foot ulcers and 1% require amputation. The recurrence rate of diabetic foot ulcers is 66%; the amputation rate rises to 12% with subsequent ulcerations. At present, this pool of patients is growing faster than the new technologies are reducing the incidence of wounds by healing them.

Wound management products are also used for a number of other conditions including amputations, carcinomas, melanomas, and other complicated skin cancers, all of which are on the increase.

A significant feature of all wounds is the likelihood of pathological infection occurring. Surgical wounds are no exception, and average levels of infection of surgical wounds are in the range of 7%–10%, depending upon the procedure. These infections can be prevented by appropriate cleanliness, surgical discipline and skill, wound care therapy, and antibiotic prophylaxis. Infections usually lead to more extensive wound care time, the use of more expensive products and drugs, significantly increased therapist time, and increased morbidity and rehabilitation time. A large number of wounds will also be sutured to accelerate closure, and a proportion of these will undergo dehiscence and require aftercare for healing to occur.

For the detailed coverage of wounds, wound management products, companies, and markets, see report #S251, “Worldwide Wound Management to 2024”.

]]>
9684
Eight Sectors of Cardiovascular Surgery Reveal Growth, Volume to 2022 http://blog.mediligence.com/2016/09/09/eight-sectors-of-cardiovascular-surgery-reveal-growth-volume-to-2022/ Fri, 09 Sep 2016 20:39:25 +0000 http://blog.mediligence.com/?p=9680 Continue reading "Eight Sectors of Cardiovascular Surgery Reveal Growth, Volume to 2022"]]> The global market for cardiovascular devices is in the billions. Its size and association with life-saving clinical utility ensures that investors will support a surprisingly strong range of innovations in an otherwise very well-established medtech market. There is stable growth in many cardio technologies that have attained “gold standard”; aggressive growth in China, India, and Japan; and select new cardio technologies expected to rapidly seize caseload. 

Report #C500, excerpted below, provides forecasts and analysis of cardiovascular surgical and interventional procedures to illustrate the volume and growth by clinical area, caseload trend, practice trend, technology introduction or regional dynamic impact.


During the forecast period 2016 to 2022, the total worldwide volume of cardiovascular surgical and interventional procedures, tracked by MedMarket Diligence, is forecast to expand on average by 3.7% per annum to over 18.73 million corresponding surgeries and transcatheter interventions in the year 2022. The largest absolute gains can be expected in peripheral arterial interventions (thanks to explosive expansion in utilization of drug-coated balloons in all market geographies), followed by coronary revascularization (supported by continued strong growth in Chinese and Indian PCI utilization) and endovascular venous interventions (driven by grossly underserved patient caseloads within the same Chinese and Indian market geography).

The latter (venous) indications are also expected to register the fastest (5.1%) relative procedural growth, followed by peripheral revascularization (with 4.0% average annual advances) and aortic aneurysm repair (projected to show a 3.6% average annual expansion).

Geographically, Asian-Pacific (APAC) market geography accounts for slightly larger share of the global CVD procedure volume than the U.S. (29.5% vs 29,3% of the total), followed by the largest Western European states (with 23.9%) and ROW geographies (with 17.3%). Because of the faster growth in all covered categories of CVD procedures, the share of APAC can be expected to increase to 33.5% of the total by the year 2022, mostly at the expense of the U.S. and Western Europe.

However, in relative per capita terms, covered APAC territories (e.g., China and India) are continuing to lag far behind developed Western states in utilization rates of therapeutic CVD interventions with roughly 1.57 procedures per million of population performed in 2015 for APAC region versus about 13.4 and 12.3 CVD interventions done per million of population in the U.S. and largest Western European countries.

screen-shot-2016-09-09-at-1-11-05-pm

Source: MedMarket Diligence, LLC; Report #C500.

Report #C500 is a worldwide and regional cardiovascular surgical and interventional procedure forecast and analysis of device market impacts.

]]>
9680
Growth of Lower Extremity Angioplasty with Drug-Coated Balloons http://blog.mediligence.com/2016/09/06/growth-of-lower-extremity-angioplasty-with-drug-coated-balloons/ Tue, 06 Sep 2016 22:32:51 +0000 http://blog.mediligence.com/?p=9672 Continue reading "Growth of Lower Extremity Angioplasty with Drug-Coated Balloons"]]> The rationale for the development of drug-coated angioplasty balloons (DCBs) derives mainly from the limitations of drug-eluting stents (DES). Nonstent-based localized drug delivery using a DCB maintains the antiproliferative properties of a DES, but without the immunogenic and hemodynamic drawbacks of a permanently implanted endovascular device. Moreover, DCBs may be used in subsets of lesions where DES cannot be delivered or where DES do not perform well. Examples include torturous vessels, small vessels or long diffuse calcified lesions, which can result in stent fracture; when scaffolding obstructs major side branches; or in bifurcated lesions.

Additional potential advantages of DCBs include:

  • homogenous drug transfer to the entire vessel wall;
  • rapid release of high concentrations of drug sustained in vessel wall no longer than a week, with little impact on long-term healing;
  • absence of polymer, which reduces the risk of chronic inflammation and late thrombosis;
  • absence of a stent, preserving the artery’s original anatomy, very important in bifurcations or small vessels to diminish abnormal flow patterns; and
  • avoided need for lengthy antiplatelet therapy.

Currently, paclitaxel is primarily used by DCB manufacturers. Its high lipophilic property allows for passive absorption through the cell membrane and sustained effect within the treated vessel wall.

Below we illustrate the rise of drug-coated balloons for peripheral angioplasty procedures in lower extremities.

Screen Shot 2016-09-06 at 3.11.12 PM

Source: Report #C500.

 

The usage of peripheral DCB in clinical practices can be expected to experience explosive growth in superficial femoral artery and femoro-popliteal below-the-knee indications to over half a million procedures annually by the year 2022. Anticipated rapid adoption of peripheral DCB technologies in the U.S. and major Asia-Pacific States (especially in China and India accounting for 95% of the covered region’s population) should work as a primary locomotive of growth of projected global procedural expansion.
IMG_2631

Source: Report #C500.

]]> 9672 Fixing congenital heart defects on a global scale http://blog.mediligence.com/2016/08/31/fixing-congenital-heart-defects-on-a-global-scale/ Wed, 31 Aug 2016 20:09:24 +0000 http://blog.mediligence.com/?p=9660 Continue reading "Fixing congenital heart defects on a global scale"]]> Congenital heart abnormalities – which occur in an estimated 1.1% to 1.3% of infants born in the U.S. and worldwide each year – constitute leading cause of birth defect-related deaths. To-date, clinicians have identified and documented almost four dozens distinctive heart defects in newly born ranging from relatively simple and easily correctible abnormalities to complex and multiple anatomical malformations.

The most commonly encountered congenital heart abnormalities accounting for the majority of all diagnosed cases include: ventricular septal defect (VSD); tetralogy of Fallot (TOF); transposition of great vessels (TGV); atrioventricular septal defect (ASD); and coarctation of aorta (COA).

Selection of treatment protocols for congenital heart defects depends on the morphology of the abnormality and its immediate and long-term impact on cardiopulmonary function and patient’s prognosis (threat to survival).

Many asymptomatic patients with minor defects (typically representing unresolved inheritance from normal fetal development, such as trans-septal conduits that are supposed to close at birth) might be put on a “watchful waiting” regime.

Some symptomatic and functionally compromising congenital heart defects can be treated with minimally invasive percutaneous (transcatheter) techniques. To-date, percutaneous repair tools have been developed and clinically tested for several common congenital myocardial abnormalities including: patent ductus arteriosus (PDA), atrial septal defect, ventricular septal defect and patent foramen ovale (PFO). In all instances, the primary objective of the transcatheter approach was to reduce morbidity, mortality and costs associated with the procedure by achieving septal repair or closure via endovascular implantation of specially-configures occluding or sealing devices.

In cases involving complex, debilitating and life threatening congenital myocardial abnormalities (such as Tetralogy of Fallot, transposition of great vessels, etc.) one or several corrective open heart surgeries represent the only route to patient survival. Such surgeries are typically performed during the first year of infant’s life and carry a 5% risk of mortality, on average.

Screen Shot 2016-08-31 at 1.03.22 PM

Source: MedMarket Diligence, LLC; Report #C500, “Global Dynamics of Cardiovascular Surgical and Interventional Procedures, 2015-2022.”

Based on the available industry data and MedMarket Diligence estimates, in 2015, approximately 387 thousand congenital heart defect repair procedures were performed worldwide, of which less invasive transcatheter interventions accounted for about 24.3% and open heart corrective surgeries for the remaining 75.7%.

During the forecast period covered in the report, the cumulative global volume of congenital heart defect repair procedures is projected to grow 1.9% per annum to approximately 444 thousand percutaneous and surgical interventions in the year 2022. The usage of transcatheter procedures can be expected to experience significantly faster 9.0% average annual growth (partially at the expense of corrective open heart surgeries for septal defects), reflecting mostly accelerated transition to minimally invasive percutaneous septal defect repair in APAC and ROW market geographies (where the latter techniques currently used only in 15% to 22% of corresponding procedures, compared to 60% to 75% in Western Europe and the U.S.).

]]>
9660
Upside from innovation, emerging markets for sealants, glues, hemostats http://blog.mediligence.com/2016/08/29/upside-from-innovation-emerging-markets-for-sealants-glues-hemostats/ Tue, 30 Aug 2016 07:10:42 +0000 http://blog.mediligence.com/?p=9657 Continue reading "Upside from innovation, emerging markets for sealants, glues, hemostats"]]> A great deal of market development has yet to take place in the field of wound closure, especially for advanced sealants, glues, and hemostats — let’s just for convenience call them “liquid closure” (as opposed to sutures/staples/clips). It is currently in an evolving, growing, consolidating, tweaking state of change, with currently more upside coming out of Asia than from innovations in sealing, adhesion, or hemostasis.

Market players dominant in one geography are absent in others. The rate of market growth arising from innovation lags growth from penetrating emerging markets, where manufacturers have rushed to pick the easy fruit.

Challenges remain in order for “liquid closure” to more deeply penetrate a caseload otherwise served by docs using strong, easy-to-use sutures, clips, and staples. Sealants are terrific in adjunctive use by “caulking” suture lines to ensure nothing leaks between, no matter how strongly the clips, etc. are holding. But the strength of sealing and adhesion are not sufficient for most products to do the job alone. A “liquid closure” must be many things with high standards that have largely yet to be met.

Hemostats, though, given their simple function to keep the life from draining out of people, have succeeded handsomely in saving lives.

For the near term, the growth in liquid closure sales is evident most strongly in Asia, with income and other drivers there giving life to an otherwise staid market, for the time being…

sealants glues hemostat overlap
MedMarket Diligence, LLC; Report #S290.
]]>
9657
The Five Highest Growth Cardiovascular Procedures http://blog.mediligence.com/2016/08/22/6-highest-growth-cardiovascular-procedures/ Mon, 22 Aug 2016 15:45:32 +0000 http://blog.mediligence.com/?p=9640 Continue reading "The Five Highest Growth Cardiovascular Procedures"]]> #5. Cerebral thrombectomy.

The initial use of cerebral thrombectomy systems has been a disappointment. It is generally assumed that the situation with end-user adoption is likely to improve dramatically in two-three years from now, when results of the ongoing major U.S. and international trials with novel cerebral thrombectomy devices become available. Growth will exceed 11% annually through 2022.

#4 Below-the-knee drug-coated balloon angioplasty for superficial femoral artery. 

There is now a broad-based consensus among leading interventional radiologists that peripheral angioplasty using DCBs should be seen as a first-line revascularization option for both primary treatment and revision of advanced arterial occlusions in the SFA vascular territory. This will lead to better than 14% annual growth in these procedures through 2022.

#3 Transcatheter heart valve replacement. 

The use of transcatheter techniques in heart valve replacement and repair is projected to grow at over 14%, to be supported by the anticipated regulatory approval of TAVR procedures for intermediate risk patients in late 2016, and, plausibly, for standard surgical risk caseloads by 2019.

#2 Left atrial appendage endovascular closure in AFib.

The global volume of endovascular LAA closure procedures is projected to experience a robust double-digit growth expanding an average of over 14% annually, nearly doubling to an estimated 52 thousand corresponding interventions in the year 2022. Anticipated strong growth in the endovascular LAA closure utilization will be driven by increasing penetration of the Asian-Pacific (primarily Chinese and Indian) market geography with an extra boost from the recent U.S. launch of transcatheter LAA closure systems. Advances in the mature European market and emerging ROW marketplace are likely to stay below projected average growth rates.

#1 Lower extremity angioplasty and DES procedures.

Lower extremity angioplasty and drug-eluting stenting is forecast to increase almost three-fold from 2016 to 2022.

From 2015 to 2022, the cumulative global volume of PTA procedures is projected to expand an average of 4.2% per annum to year 2022. The cited expansion will be driven largely by a strong annual procedural growth in the APAC region (primarily in China and India undergoing aggressive transition to modern interventional radiology practices), which is forecast to account for about over a third of PTAs performed worldwide in 2022. The U.S. and Western European geographies can be expected to register only a moderate PTA procedural growth to be supported mostly by increasing penetration of the SFA patient caseloads with DES-based interventions, but the worldwide utilization of stented PTAs (especially these employing DES devices) is forecast to grow at significantly faster (4.2% and 19.1%) average annual rates to over 986,000 and 203,000 corresponding procedures in the year 2022.

Screen Shot 2016-08-22 at 8.44.25 AM

Source: MedMarket Diligence, Report #C500.


From “Global Dynamics of Surgical and Interventional Cardiovascular Procedures, 2015-2022.” Report #C500.

 

 

]]>
9640
Endovascular Repair of TAA and AAA http://blog.mediligence.com/2016/08/18/endovascular-repair-of-taa-and-aaa/ Thu, 18 Aug 2016 21:34:03 +0000 http://blog.mediligence.com/?p=9627 Continue reading "Endovascular Repair of TAA and AAA"]]> Drawn from “Global Dynamics of Surgical and Interventional Cardiovascular Procedures, 2015-2022.”

Abdominal Aortic Aneurysm. During the past two decades, advances in interventional technologies paved the way for the advent of a considerably less invasive and risky endovascular AAA repair procedure. The procedure involves a transcatheter deployment of the specially designed endovascular prosthesis (typically combining sealing functions of the vascular graft and full or partial stenting support structure) into a defective segment of aorta with the goal of excluding the aneurysmal sac from blood circulation.

The endovascular stent-grafts (SGs) – which come both in self-expanding or balloon-expandable versions – are typically anchored to an undamaged part of the aorta both above and below the aneurysm via a compression fit or/and with a special fixation mechanism like hooks, barbs, etc.

To accommodate a great morphological diversity of aortic aneurysms the vast majority of endovascular SGs is employing a modular design concept providing the aorto iliac, bifurcated and straight tubular device configurations to cover a variety of AAA indications. Several SG systems also feature an open stenting structure at proximal end to enable suprarenal device deployment required in about 30% to 35% of all AAA cases warranting intervention.

In its idea, the endovascular repair of abdominal aortic aneurysm was intended to produce clinical outcomes comparable to these yielded by the open surgery, while reducing the associated trauma, recovery time, morbidity and the overall treatment cost. It was also generally expected that availability of less-invasive endovascular treatment option would allow to extend caseloads coverage to sizable rupture-prone AAA patient subsets who are poor surgical candidates.

Thoracic Aortic Aneurysms. Introduced in Europe and the U.S. in 1998 and 2005, accordingly, endovascular techniques for aneurysm (and aortic dissection) repair on thoracic aorta represented a logical extension of the very same basic concept and technology platforms that enabled the development of AAA stent-grafts.

Because of extremely high mortality and morbidity rates associated with TAA surgery, the need for minimally invasive endovascular treatment option was even more compelling than that in AAA case.

Similar to AAA endovascular repair devices, TAA stent-grafts are intended to minimize the risk of catastrophic thoracic aortic aneurysm rupture via effective exclusion (isolation) of the aneurismal sac from blood circulation.

Unlike AAA implants, commercially available TAA stent-grafting devices feature relatively simple tubular unibody architecture with sealing cuffs (or flanges) at proximal and distal end.

Insertion of TAA SGs is done under fluoroscopic guidance via a singular femoral puncture with the use of standard transcatheter techniques. Depending on the aneurysm morphology, one or two overlapping devices might be used to ensure proper aneurismal sac isolation.

The average ICU and hospital stays and post-discharge recovery period for endovascular TAA repair procedure are generally similar to these for AAA stent-grafting intervention.

Although practical clinical experience with endovascular repair of thoracic aortic aneurysm remains somewhat limited, findings from European and U.S. clinical studies with TAA stent-grafting tend to be very encouraging. Based on these findings, stent-grafting of rupture-prone aneurysm on ascending thoracic aorta can be performed with close to perfect technical success rate yielding radical reduction in intraoperative mortality and complications compared to TAA surgery as well as impressive improvement in long-term patient survival.

Similar to AAA endografting, the main problems associated with the use of TAA SG systems include significant incidence of endoleaks and occasional device migration which require reintervention.

Below is illustrated a comparison of the two most significant markets for AAA and TAA repair, the U.S. and Asia/Pacific. Two points are clear: (1) A significant portion of potential treatment caseload in AAA/TAA has yet to be realized, and (2) the U.S. and Asia/Pacific markets operate by different rules.

AAAandTAA

See link.

]]> 9627 The future of cardiovascular medicine http://blog.mediligence.com/2016/08/16/the-future-of-cardiovascular-medicine/ Wed, 17 Aug 2016 06:22:09 +0000 http://blog.mediligence.com/?p=9621 The MedMarket Diligence has published a global analysis and forecast of cardiovascular procedures, designed to be a resource for active participants or others with interest in the future of cardiovascular medicine and cardiovascular technologies.

See the press release on Medgadget.

]]>
9621
10 Facts About Medical Technologies that will Impress Your Friends http://blog.mediligence.com/2016/08/16/10-facts-about-medical-technologies-that-will-impress-your-friends/ Tue, 16 Aug 2016 20:11:46 +0000 http://blog.mediligence.com/?p=9619 Continue reading "10 Facts About Medical Technologies that will Impress Your Friends"]]>
  • In catheterization, a doctor can poke a hole in your leg and fix your heart.
  • Radiosurgery can destroy a tumor and leave adjacent tissue untouched, touching the body only with energy.
  • A doctor thousands of miles away can do surgery on you via telepresence and robotic instrumentation.
  • Medical device implants like stents have been developed to simply dissolve over time.
  • Doctors can see cancer via live imaging during operations to ensure that they excise it all.
  • Type 1 diabetics may soon be able to so easily manage their condition, via combined insulin pump / glucometer that they may almost forget they have diabetes (or cell therapy may cure them!), while Type 2 diabetics will grow in number and cost to manage.
  • Organs are already being printed, as are other tissue implants.
  • Neuroprosthetics, exoskeletons and related technologies are enabling wheelchair-bound and other physically challenged people to walk upright, allowing amputees to control prosthetics with their mind,
  • Almost two-thirds of the 7,000 medical device firms in the United States have fewer than 20 employees — Medtronic employs all the rest. (OK, that’s an exaggeration.)
  • Science fiction continues to drive the imagination of medtech innovators. Decentralized diagnostics — very small, efficient devices in the hands of a doctor that will rapidly assist in diagnoses and expedite the process of intervention — are becoming pervasive, ideally embodied in the fictional “tricorder” in Star Trek.
  • ]]>
    9619
    Percutaneous Transluminal Angioplasty and Stenting Reconsidered http://blog.mediligence.com/2016/08/15/percutaneous-transluminal-angioplasty-and-stenting-reconsidered/ Mon, 15 Aug 2016 17:13:26 +0000 http://blog.mediligence.com/?p=9612 Continue reading "Percutaneous Transluminal Angioplasty and Stenting Reconsidered"]]> Originally developed by the Swiss physician Andreas Gruentzig as a less traumatic alternative to CABG, and first performed in the U.S. in 1978, percutaneous transluminal coronary angioplasty (PTCA) has soon emerged as a mainstream revascularization modality, particularly well-suited for singular concentric coronary artery occlusions.

    PTCA is a minimally invasive procedure intended to restore normal (or nearly normal) blood circulation in occluded coronary arteries through a radial dilation of atherosclerotic plaque and its compression against arterial wall with transluminally-placed inflatable balloon.

    In PTCA procedure, occluding coronary lesion is first crossed with appropriate guidewire, which is typically inserted under fluoroscopic guidance through a puncture in femoral artery and brought to the treatment site via iliac artery and aortic tree. A special balloon-tipped catheter is then deployed over the guidewire across the targeted lesion and repeatedly inflated to provide a required reopening of the arterial lumen. The catheter is then withdrawn and arterial puncture is secured with the use of external pressure aids or special vascular puncture closure device.

    Despite some indisputable benefits of “plain old balloon angioplasty,” its ultimate clinical efficacy was seriously compromised by the disappointingly high rate of restenosis that ran as high as 50% at six months and typically required re-intervention. Introduction of coronary bare metal stents (BMS) in the early 1990s allowed to partially alleviate that problem by reducing the average restenosis rate by about one-half. Stents also helped to virtually eliminate many of the complications of conventional angioplasty, such as abrupt and unpredictable collapse and closure of the vessel, which resulted in emergency bypass surgery.

    Since the introduction of bare metal coronary stents, the usage of angioplasty expanded considerably, supplanting CABG as the most commonly employed modality of myocardial revascularization.

    By the beginning of the past decade, though, growth in PTCA and coronary stenting caseloads started to slow down in the U.S., Europe, and Japan reflecting significant penetration of technically feasible CAD indications and a disappointingly high rate of post-PTCA and in-stent restenosis. The problem of restenosis represented a single major handicap of coronary angioplasty/stenting, which hampered its ultimate clinical outcomes and often forced a revision and eventual conversion to bypass surgery.

    In the opinion of many leading clinicians and industry’s analysts, introduction of drug-eluting stents (DES) represented the single most important innovation in endovascular therapy, since the advent of stenting and angioplasty that was bound to have a revolutionary impact on interventional cardiology practices.  In addition to effectively remedying the nagging problem of coronary restenosis (by reducing its rates to mid-low digit figures), the drug-eluting devices also enabled interventional cardiologists to successfully manage coronary indications and patient caseloads that were traditionally deemed unsuited for angioplasty and stenting. The latter include treatment of small diameter vessels, long and bifurcated lesions, left main artery and multivessel disease, as well as expanded coverage of high-risk patient cohorts with advanced diabetes, renal insufficiency/failure and recent major AMI.

    Unfortunately, in the middle of the past decade, one could witness a gradually growing concerns about relatively high incidence (compared to BMS) of late and very late stent thrombosis (often leading to AMI and death) and overall safety of DES, that have prompted several warning letters, but were generally ignored due to initial exuberance about superb antirestenotic performance of DES technology. Following a release of disturbing findings from several major studies in 2006, the cited concerns appeared to reach a “critical mass” bringing the safety issues to the forefront of renewed DES debates and ultimately prompting a very significant decline in DES usage and cumulative PCI procedure volumes in the U.S. and Europe.

    In the view of many leading clinicians, the higher propensity of drug-eluting stents to late (and very late) thrombosis is stemming from the very nature of current DES technology which is focused primarily on prophylaxis of binary restenosis via distortion and inhibition of natural healing processes involving neointimal outgrowth. The latter, by definition, lead to a significantly delayed epithelialization and protracted stent struts exposure to the blood stream, which have been identified as the main sources of thrombogenicity. According to multiple IVUS and pathology studies, incomplete endothelialization of DES (with associated bare strut exposure and device malapposition) is commonly observed at 3 to 4 years post-implantation, in contrast to full epithelial coverage of BMS occurring at 5 to 6 months after stent placement.

    Early termination of dual (aspirin-clopidogrel) antiplatelet regimens due to patient’s non-compliance, serious complications, or other reasons appears to represent another major contributing factor to onset of late thrombotic events. Based on available data, the vast majority of DES-related thrombosis episodes tend to occur at 1.0 to 3.5 years post-implantation, or after the recommended 12-month period of dual antiplatelet therapy. According to clinical literature, other factors implicated in the occurrence of late and very late DES thrombosis include presence of inflammatory polymer on stent, incomplete drug elution, rate of drug elution, cytotoxicity of chosen drug, as well as poor DES patient selection (e.g., utilization of DES in high-risk diabetics, and their off-label uses in small diameter vessels, patients with long and bifurcated lesions, etc.).

    Most of the cited problems were effectively addressed by the next-generation DES devices that combine sophisticated cobalt and platinum alloy stenting platforms and biodegradable drug coatings with super-low-profile delivery and minimally traumatic deployment systems.

    It is assumed that clinical efficacy and utility of DES technology would be significantly enhanced with the advent of specialty bifurcation-targeting devices, vascular healing-focused biopharmaceutical coatings, and in increased adoption of fully biodegradable stenting systems.


    For forecasts of off-pump CABG, on-pump CABG, primary PCI with stenting, and drug-eluting stent-based PCI procedures (separately for U.S. Western Europe, Asia/Pacific and Rest of World), as well as all major cardiovascular surgical and interventional procedures, see Report #C500, “Global Dynamics of Surgical and Interventional Cardiovascular Procedures, 2015-2022.”

    ]]>
    9612
    Medtech fundings for August 2016 http://blog.mediligence.com/2016/08/15/medtech-fundings-for-august-2016/ Mon, 15 Aug 2016 16:53:31 +0000 http://blog.mediligence.com/?p=9608 Continue reading "Medtech fundings for August 2016"]]> The top fundings for medical technology companies in August 2015 totaled a modest $335.1 million.


    See the 2016 global reports:

    Surgical Sealants, Glues, Hemostats, 2015-2022. details

    Global Dynamics of Cardiovascular Surgical and Interventional Procedures, 2015–2022. details


    Fundings for August 2016 were led by the $93 million funding of CVRx, followed by the $49 million funding of Auris Surgical Robots, and the $30 million funding of VytronUS. See link for the complete list.

    IMG_2020

    For a comprehensive list of medtech fundings since 2009, see link.

     

    ]]>
    9608
    New Global Cardiovascular Procedures Report Reveals Medtech Outlook http://blog.mediligence.com/2016/08/14/new-global-cardiovascular-procedures-report-reveals-medtech-outlook/ Mon, 15 Aug 2016 05:03:13 +0000 http://blog.mediligence.com/?p=9604 Continue reading "New Global Cardiovascular Procedures Report Reveals Medtech Outlook"]]> MedMarket Diligence has published, “Global Dynamics of Surgical and Interventional Cardiovascular Procedures, 2015-2022.”

    See link for report description, sources, table of contents, and list of exhibits. The report may be purchased for download.

    The report details the therapeutic procedures that address acute and chronic conditions affecting myocardium and vascular system, with relevant prevalences, incidence rates, separate procedure counts for surgical versus interventional and other key splits of the procedure volume.

    Screen Shot 2016-08-12 at 9.48.46 AMThe report offers current assessment and projected procedural dynamics (2015 to 2022) for primary market geographies (e.g., United States, Largest Western European Countries, and Major Asian States) as well as the rest-of-the-world.

    Each set of forecasts is accompanied by discussion per condition of the changing clinical practice and technology adoption rates, procedural limitations or drivers competitively, the surgical-interventional balance, and the resulting market outlook for cardio manufacturers.

    Excerpts available on request.

    ]]>
    9604
    Surgical and interventional cardiovascular procedures, worldwide http://blog.mediligence.com/2016/08/11/surgical-and-interventional-cardiovascular-procedures-worldwide/ Thu, 11 Aug 2016 23:33:53 +0000 http://blog.mediligence.com/?p=9593 Continue reading "Surgical and interventional cardiovascular procedures, worldwide"]]> In August 2016, MedMarket Diligence will be releasing Report #C500, “Global Dynamics of Surgical and Interventional Cardiovascular Procedures, 2015-2022”. The report details prevalence, incidence, and caseload for the following procedures, forecast to 2022, and examines the clinical practice trends, technologies emerging on the market, and the dynamics leading to trends in procedures utilization and technology adoption.

    Surgical and interventional procedures included:

    • Coronary artery bypass graft (CABG) surgery
    • Coronary angioplasty and stenting
    • Lower extremity arterial bypass surgery
    • Percutaneous transluminal angioplasty (PTA) with and without bare metal and drug-eluting stenting
    • Peripheral drug-coated balloon angioplasty
    • Peripheral atherectomy
    • Surgical and endovascular aortic aneurysm repair
    • Vena cava filter placement
    • Endovenous ablation
    • Mechanical venous thrombectomy
    • Venous angioplasty and stenting
    • Carotid endarterectomy
    • Carotid artery stenting
    • Cerebral thrombectomy
    • Cerebral aneurysm and AVM surgical clipping
    • Cerebral aneurysm and AVM coiling & flow diversion
    • Left Atrial Appendage closure
    • Heart valve repair and replacement surgery
    • Transcatheter valve repair and replacement
    • Congenital heart defect repair
    • Percutaneous and surgical placement of temporary and permanent mechanical cardiac support devices
    • Pacemaker implantation
    • Implantable cardioverter defibrillator placement
    • Cardiac resynchronization therapy device placement
    • Standard SVT & VT ablation
    • Transcatheter AFib ablation

    In very general terms, the category “cardiovascular diseases” (CVD) refers to a variety of acute and chronic medical conditions resulting in the inability of cardiovascular system to sustain an adequate blood flow and supply of oxygen and nutrients to organs and tissues of the body. The CVD conditions could be manifested by the obstruction or deformation of arterial and venous pathways, distortion in the electrical conducting and pacing activity of the heart, and impaired pumping function of the heart muscle, or some combination of circulatory, cardiac rhythm, and myocardial disorders

    The scope of this report covers surgical and interventional therapeutic procedures commonly used in the management of acute and chronic conditions affecting myocardium and vascular system. The latter include ischemic heart disease (and its life threatening manifestations like AMI, cardiogenic shock, etc.); heart failure; structural heart disorders (valvular abnormalities and congenital heart defects); peripheral artery disease (and limb and life threatening critical limb ischemia); aortic disorders (AAA, TAA and aortic dissections); acute and chronic venous conditions (such as deep venous thrombosis, pulmonary embolism and chronic venous insufficiency); neurovascular pathologies associated with high risk of hemorrhagic and ischemic stroke (such as cerebral aneurysms and AVMs, and high-grade carotid/intracranial stenosis); and cardiac rhythm disorders (requiring correction with implantable pulse generators/IPG or arrhythmia ablation).

    The report offers current assessment and projected procedural dynamics (2015 to 2022) for primary market geographies (e.g., United States, Largest Western European Countries, and Major Asian States) as well as the rest-of-the-world.

    The cited procedural assessments and forecasts are based on the systematic analysis of multiplicity of sources including (but not limited to):

    • latest and historic company SEC filings, corporate presentations, and interviews with product management and marketing staffers;
    • data released by authoritative international institutions (such as OECD and WHO), and national healthcare authorities;
    • statistical updates and clinical practice guidelines from professional medical associations (like AHA, ACC, European Society of Cardiology, etc.);
    • specialty presentations at major professional conferences (e.g., TCT, AHA Scientific Sessions, EuroPCR, etc.);
    • publications in major medical journals (JAMA, NEJM, British Medical Journal, etc.) and specialty magazines (CathLab Digest, EP Digest, Endovascular Today, etc.);
    • findings from relevant clinical trials;
    • feedbacks from leading clinicians (end-users) in the field on device/procedure utilization trends and preferences; and
    • policy papers by major medical insurance carriers on uses of particular surgical and interventional tools and techniques, their medical necessity and reimbursement.

    Surgical and Interventional Procedures Covered in the report include:

    • Coronary artery bypass graft (CABG) surgery;
    • Coronary angioplasty and stenting;
    • Lower extremity arterial bypass surgery;
    • Percutaneous transluminal angioplasty (PTA) with and without bare metal and drug-eluting stenting;
    • Peripheral drug-coated balloon angioplasty;
    • Peripheral atherectomy;
    • Surgical and endovascular aortic aneurysm repair;
    • Vena cava filter placement
    • Endovenous ablation;
    • Mechanical venous thrombectomy;
    • Venous angioplasty and stenting;
    • Carotid endarterectomy;
    • Carotid artery stenting;
    • Cerebral thrombectomy;
    • Cerebral aneurysm and AVM surgical clipping;
    • Cerebral aneurysm and AVM coiling & flow diversion;
    • Left Atrial Appendage closure;
    • Heart valve repair and replacement surgery;
    • Transcatheter valve repair and replacement;
    • Congenital heart defect repair;
    • Percutaneous and surgical placement of temporary and permanent mechanical cardiac support devices;
    • Pacemaker implantation;
    • Implantable cardioverter defibrillator placement;
    • Cardiac resynchronization therapy device placement;
    • Standard SVT & VT ablation; and
    • Transcatheter AFib ablation

    In 2016, cumulative worldwide volume of the aforementioned CVD procedures is projected to approach 15.05 million surgical and transcatheter interventions. This will include:

    • Roughly 4.73 million coronary revascularization procedures via CABG and PCI (or about 31.4% of the total),
    • Close to 4 million percutaneous and surgical peripheral artery revascularization procedures (or 26.5% of the total);
    • About 2.12 million cardiac rhythm management procedures via implantable pulse generator placement and arrhythmia ablation (or 14.1% of the total);
    • Over 1.65 million CVI, DVT, and PE targeting venous interventions (representing 11.0% of the total);
    • More than 992 thousand surgical and transcatheter heart defect repairs and valvular interventions (or 6.6% of the total);
    • Close to 931 thousand acute stroke prophylaxis and treatment procedures (contributing 6.2% of the total);
    • Over 374 thousand abdominal and thoracic aortic aneurysm endovascular and surgical repairs (or 2.5% of the total); and
    • Almost 254 thousand placements of temporary and permanent mechanical cardiac support devices in bridge to recovery, bridge to transplant, and destination therapy indications (accounting for about 1.7% of total procedure volume).

    During the forecast period, the total worldwide volume of covered cardiovascular procedures is forecast to expand on average by 3.7% per annum to over 18.73 million corresponding surgeries and transcatheter interventions in the year 2022. The largest absolute gains can be expected in peripheral arterial interventions (thanks to explosive expansion in utilization of drug-coated balloons in all market geographies), followed by coronary revascularization (supported by continued strong growth in Chinese and Indian PCI utilization) and endovascular venous interventions (driven by grossly underserved patient caseloads within the same Chinese and Indian market geography).




    The latter (venous) indications are also expected to register the fastest (5.1%) relative procedural growth, followed by peripheral revascularization (with 4.0% average annual advances) and aortic aneurysm repair (projected to show a 3.6% average annual expansion).

    Geographically, Asian-Pacific (APAC) market geography accounts for slightly larger share of the global CVD procedure volume than the U.S. (29.5% vs 29,3% of the total, followed by the largest Western European states (with 23.9%) and ROW geographies (with 17.3%). Because of the faster growth in all covered categories of CVD procedures, the share of APAC can be expected to increase to 33.5% of the total by the year 2022, mostly at the expense of the U.S. and Western Europe.

    Screen Shot 2016-08-12 at 9.48.46 AM

    Source: MedMarket Diligence, LLC; Report #C500.

    However, in relative per capita terms, covered APAC territories (e.g., China and India) are continuing to lag far behind developed Western states in utilization rates of therapeutic CVD interventions with roughly 1.57 procedures per million of population performed in 2015 for APAC region versus about 13.4 and 12.3 CVD interventions done per million of population in the U.S. and largest Western European countries.

    See “Global Dynamics of Surgical and Interventional Cardiovascular Procedures, 2015-2022”, Report #C500 (publishing August 2016).

    ]]>
    9593
    List of high growth medtech products http://blog.mediligence.com/2016/08/09/list-of-high-growth-medtech-products/ Tue, 09 Aug 2016 15:28:32 +0000 http://blog.mediligence.com/?p=9569 Continue reading "List of high growth medtech products"]]> Below is a table with a list of the market segments demonstrating greater than 10% compound annual growth rate for the associated region through 2022, drawn from our reports on tissue engineering & cell therapy, wound management, ablation technologies, stroke, peripheral stents, and sealants/glues/hemostats. Products with over 10% CAGR in sales are shown in descending order of CAGR.

    RankProductTopicRegion
    1General, gastrointestinal, ob/gyn, othertissue/cellWW
    2Ophthalmologytissue/cellWW
    3Organ Replacement/ Repairtissue/cellWW
    4Urologicaltissue/cellWW
    5Neurologicaltissue/cellWW
    6Autoimmune Diseasestissue/cellWW
    7CV/ Vasculartissue/cellWW
    8Bioengineered skin and skin substituteswoundRest of A/P
    9Peripheral drug-eluting stents (A/P)peripheral interventionalA/P
    10Peripheral drug eluting stentsperipheral interventionalRoW
    11Peripheral drug-eluting stents (US)peripheral interventionalUS
    12Negative pressure wound therapywoundGermany
    13Hydrocolloid dressingswoundRest of A/P
    14Cancertissue/cellWW
    15Foam dressingswoundRest of A/P
    16Growth factorswoundRest of A/P
    17Alginate dressingswoundRest of A/P
    18Dentaltissue/cellWW
    19Bioengineered skin and skin substituteswoundJapan
    20Hemostatssealants, glues, hemostatsA/P
    21Skin/ Integumentarytissue/cellWW
    22Bioengineered skin and skin substitutessealants, glues, hemostatsUS
    23Bioengineered skin and skin substitutessealants, glues, hemostatsWW
    24Film dressingswoundRest of A/P
    25Surgical sealantssealants, glues, hemostatsA/P
    26Hydrogel dressingswoundRest of A/P
    27TAA Stent graftsperipheral interventionalA/P
    28Negative pressure wound therapywoundRoW
    29Biological gluessealants, glues, hemostatsA/P
    30FoamwoundRoW
    31HydrocolloidwoundGermany
    32AAA Stent graftsperipheral interventionalA/P
    33Cerebral thrombectomy systemsstrokeA/P
    34High-strength medical gluessealants, glues, hemostatsA/P
    35Carotid artery stenting systemsstrokeA/P
    36Cardiac RF ablation productsablationA/P
    37Alginate dressingswoundGermany
    38Peripheral venous stentsperipheral interventionalA/P
    39Cerebral thrombectomy systemsstrokeUS
    40Left atrial appendage closure systemsstrokeA/P
    41Cyanoacrylate gluessealants, glues, hemostatsA/P
    42Foam dressingswoundRest of EU
    43Foam dressingswoundKorea
    44Cryoablation cardiac & vascular productsablationA/P
    45Bioengineered skin and skin substituteswoundGermany
    46Thrombin, collagen & gelatin-based sealantssealants, glues, hemostatsA/P
    47Cardiac RF ablation productsablationRoW
    48Bioengineered skin and skin substituteswoundRoW
    49Microwave oncologic ablation productsablationA/P

    Note source links: Tissue/Cell, Wound, Sealants/Glues/Hemostats, Peripheral Stents, Stroke, Ablation.

    Source: MedMarket Diligence Reports

    ]]>
    9569
    Components used in surgical sealants http://blog.mediligence.com/2016/08/08/components-used-in-surgical-sealants/ Tue, 09 Aug 2016 00:14:59 +0000 http://blog.mediligence.com/?p=9562 While fibrin is a biological sealant that has been harnessed by several companies to provide tissue sealing, a wide variety of other components and component combinations have been developed for sealant use.

    Below are sealant formulations from selected participants in the market for surgical sealants:

    Sealant Components by Manufacturer

    CompanySealant component(s)
    AdhesysPolyurethane
    CoheraUrethane & lysine
    EndomedixDextran and chitosan biopolymers
    Gecko BiomedicalProprietary, light-activated, synthetic elastomer
    GrifolsFibrin sealant
    BaxterHuman fibrinogen and thrombin
    EthiconFibrin sealant
    BardHydrogel
    TakedaFibrin sealant
    The Medicines CompanyFibrin sealant, and synthetic sealant
    CryoLifeBovine serum albumin and glutaraldehyde adhesive
    HyperbranchActivated polyethylene glycol polyethlyeneimine
    Integra LifesciencePolyethylene glycol hydrogel
    LifeBondPolymer hydrogel matrix
    Ocular TherapeutixPolyethylene glycol and trilysine
    SealantisAlga-mimetic tissue adhesives

    Source: MedMarket Diligence, LLC; Report #S290.

    ]]>
    9562
    Peripheral Vascular Stents http://blog.mediligence.com/2016/08/08/peripheral-vascular-stents/ Mon, 08 Aug 2016 20:15:06 +0000 http://blog.mediligence.com/?p=9557 Continue reading "Peripheral Vascular Stents"]]> The market for stents used in peripheral vascular indications — inclusive of stent grafts, and arterial and venous stents — is growing at an aggregate 6.2% CAGR from 2016 to 2020, which belies much stronger growth in specific subsets, especially in emerging markets like Asia/Pacific.

    The aggregate compound growth rates for peripheral stent markets in each global region is shown below, with growth rates weighted by individual segment sales:

    U.S.:  9.5%
    Western Europe: 5%
    Asia/Pacific: 21.3%
    Rest of World: 13.9%

    Peripheral stent products include the following, each of which is growing in sales at varying rates above and below the aggregregate regional sales growth:

    Peripheral Arterial Stenting

    – Bare Metal Stent Devices

    – Drug Eluting Stent Devices

    Aortic Aneurysm Repair

    – Abdominal AA Stent-Grafts

    – Thoracic AA Stent-Grafts

    Peripheral Venous Stents

     

    Worldwide Peripheral Stent Market by Product Category, 2015 and 2020

    Screen Shot 2016-08-08 at 12.49.53 PM

    Source: MedMarket Diligence, LLC; Report #V201.

    ]]>
    9557
    Where will medicine be in 2035? http://blog.mediligence.com/2016/08/08/where-will-medicine-be-in-2035/ http://blog.mediligence.com/2016/08/08/where-will-medicine-be-in-2035/#respond Mon, 08 Aug 2016 19:45:15 +0000 http://blog.mediligence.com/?p=8376 Continue reading "Where will medicine be in 2035?"]]> An important determinant of “where medicine will be” in 2035 is the set of dynamics and forces behind healthcare delivery systems, including primarily the payment method, especially regarding reimbursement. It is clear that some form of reform in healthcare will result in a consolidation of the infrastructure paying for and managing patient populations. The infrastructure is bloated and expensive, unnecessarily adding to costs that neither the federal government nor individuals can sustain. This is not to say that I predict movement to a single payer system — that is just one perceived solution to the problem. There are far too many costs in healthcare that offer no benefits in terms of quality; indeed, such costs are a true impediment to quality. Funds that go to infrastructure (insurance companies and other intermediaries) and the demands they put on healthcare delivery work directly against quality of care. So, in the U.S., whether Obamacare persists (most likely) or is replaced with a single payer system, state administered healthcare (exchanges) or some other as-yet-unidentified form, there will be change in how healthcare is delivered from a cost/management perspective. 

    From the clinical practice and technology side, there will be enormous changes to healthcare. Here are examples of what I see from tracking trends in clinical practice and medical technology development:

    • Cancer 5 year survival rates will, for many cancers, be well over 90%. Cancer will largely be transformed in most cases to chronic disease that can be effectively managed by surgery, immunology, chemotherapy and other interventions. Cancer and genomics, in particular, has been a lucrative study (see The Cancer Genome Atlas). Immunotherapy developments are also expected to be part of many oncology solutions. Cancer has been a tenacious foe, and remains one we will be fighting for a long time, but the fight will have changed from virtually incapacitating the patient to following protocols that keep cancer in check, if not cure/prevent it. 
    • Diabetes Type 1 (juvenile onset) will be managed in most patients by an “artificial pancreas”, a closed loop glucometer and insulin pump that will self-regulate blood glucose levels. OR, stem cell or other cell therapies may well achieve success in restoring normal insulin production and glucose metabolism in Type 1 patients. The odds are better that a practical, affordable artificial pancreas will developed than stem or other cell therapy, but both technologies are moving aggressively and will gain dramatic successes within 20 years.

    Developments in the field of the “artificial pancreas” have recently gathered considerable pace, such that, by 2035, type 1 blood glucose management may be no more onerous than a house thermostat due to the sophistication and ease-of-use made possible with the closed loop, biofeedback capabilities of the integrated glucometer, insulin pump and the algorithms that drive it, but that will not be the end of the development of better options for type 1 diabetics. Cell therapy for type 1 diabetes, which may be readily achieved by one or more of a wide variety of cellular approaches and product forms (including cell/device hybrids) may well have progressed by 2035 to become another viable alternative for type 1 diabetics.

    • Diabetes Type 2 (adult onset) will be a significant problem governed by different dynamics than Type 1. A large body of evidence will exist that shows dramatically reduced incidence of Type 2 associated with obesity management (gastric bypass, satiety drugs, etc.) that will mitigate the growing prevalence of Type 2, but research into pharmacologic or other therapies may at best achieve only modest advances. The problem will reside in the complexity of different Type 2 manifestation, the late onset of the condition in patients who are resistant to the necessary changes in lifestyle and the global epidemic that will challenge dissemination of new technologies and clinical practices to third world populations.

    Despite increasing levels of attention being raised to the burden of type 2 worldwide, including all its sequellae (vascular, retinal, kidney and other diseases), the pace of growth globally in type 2 is still such that it will represent a problem and target for pharma, biotech, medical device, and other disciplines.

    • Cell therapy and tissue engineering will offer an enormous number of solutions for conditions currently treated inadequately, if at all. Below is an illustration of the range of applications currently available or in development, a list that will expand (along with successes in each) over the next 20 years.

      Cell therapy will have deeply penetrated virtually every medical specialty by 2035. Most advanced will be those that target less complex tissues: bone, muscle, skin, and select internal organ tissues (e.g., bioengineered bladder, others). However, development will have also followed the money. Currently, development and use of conventional technologies in areas like cardiology, vascular, and neurology entails high expenditure that creates enormous investment incentive that will drive steady development of cell therapy and tissue engineering over the next 20 years, with the goal of better, long-term and/or less costly solutions.
    • Gene therapy will be an option for a majority of genetically-based diseases (especially inherited diseases) and will offer clinical options for non-inherited conditions. Advances in the analysis of inheritance and expression of genes will also enable advanced interventions to either ameliorate or actually preempt the onset of genetic disease.

      As the human genome is the engineering plans for the human body, it is a potential mother lode for the future of medicine, but it remains a complex set of plans to elucidate and exploit for the development of therapies. While genetically-based diseases may readily be addressed by gene therapies in 2035, the host of other diseases that do not have obvious genetic components will resist giving up easy gene therapy solutions. Then again, within 20 years a number of reasonable advances in understanding and intervention could open the gate to widespread “gene therapy” (in some sense) for a breadth of diseases and conditions –> Case in point, the recent emergence of the gene-editing technology, CRISPR, has set the stage for practical applications to correct genetically-based conditions.
    • Drug development will be dramatically more sophisticated, reducing the development time and cost while resulting in drugs that are far more clinically effective (and less prone to side effects). This arises from drug candidates being evaluated via distributed processing systems (or quantum computer systems) that can predict efficacy and side effect without need of expensive and exhaustive animal or human testing.The development of effective drugs will have been accelerated by both modeling systems and increases in our understanding of disease and trauma, including pharmacogenomics to predict drug response. It may not as readily follow that the costs will be reduced, something that may only happen as a result of policy decisions.
    • Most surgical procedures will achieve the ability to be virtually non-invasive. Natural orifice transluminal endoscopic surgery (NOTES) will enable highly sophisticated surgery without ever making an abdominal or other (external) incision. Technologies like “gamma knife” and similar will have the ability to destroy tumors or ablate pathological tissue via completely external, energy-based systems.

      By 2035, technologies such as these will measurably reduce inpatient stays, on a per capita basis, since a significant reason for overnight stays is the trauma requiring recovery, and eliminating trauma is a major goal and advantage of minimally invasive technologies (e.g., especially the NOTES technology platform). A wide range of other technologies (e.g., gamma knife, minimally invasive surgery/intervention, etc.) across multiple categories (device, biotech, pharma) will also have emerged and succeeded in the market by producing therapeutic benefit while minimizing or eliminating collateral damage.

    Information technology will radically improve patient management. Very sophisticated electronic patient records will dramatically improve patient care via reduction of contraindications, predictive systems to proactively manage disease and disease risk, and greatly improve the decision-making of physicians tasked with diagnosing and treating patients.There are few technical hurdles to the advancement of information technology in medicine, but even in 2035, infotech is very likely to still be facing real hurdles in its use as a result of the reluctance in healthcare to give up legacy systems and the inertia against change, despite the benefits.

    • Personalized medicine. Perfect matches between a condition and its treatment are the goal of personalized medicine, since patient-to-patient variation can reduce the efficacy of off-the-shelf treatment. The thinking behind gender-specific joint replacement has led to custom-printed 3D implants. The use of personalized medicine will also be manifested by testing to reveal potential emerging diseases or conditions, whose symptoms may be ameliorated or prevented by intervention before onset.
    • Systems biology will underlie the biology of most future medical advances in the next 20 years. Systems biology is a discipline focused on an integrated understanding of cell biology, physiology, genetics, chemistry, and a wide range of other individual medical and scientific disciplines. It represents an implicit recognition of an organism as an embodiment of multiple, interdependent organ systems and its processes, such that both pathology and wellness are understood from the perspective of the sum total of both the problem and the impact of possible solutions.This orientation will be intrinsic to the development of medical technologies, and will increasingly be represented by clinical trials that throw a much wider and longer-term net around relevant data, staff expertise encompassing more medical/scientific disciplines, and unforeseen solutions that present themselves as a result of this approach.Other technologies being developed aggressively now will have an impact over the next twenty years, including medical/surgical robots (or even biobots), neurotechnologies to diagnose, monitor, and treat a wide range of conditions (e.g., spinal cord injury, Alzheimer’s, Parkinson’s etc.).

    The breadth and depth of advances in medicine over the next 20 years will be extraordinary, since many doors have been recently opened as a result of advances in genetics, cell biology, materials science, systems biology and others — with the collective advances further stimulating both learning and new product development. 


    See the 2016 report #290, “Worldwide Markets for Medical and Surgical Sealants, Glues, and Hemostats, 2015-2022.”

    ]]>
    http://blog.mediligence.com/2016/08/08/where-will-medicine-be-in-2035/feed/ 0 8376