advanced medical technologies insights, perspectives and inside data from medtech market analysis at MedMarket Diligence, LLC Wed, 19 Oct 2016 15:32:13 +0000 en-US hourly 1 66423588 Cerebral thrombectomy procedures worldwide Mon, 17 Oct 2016 11:02:51 +0000 Continue reading "Cerebral thrombectomy procedures worldwide"]]>

In 2014, approximately 33.7 thousand cerebral thrombectomy procedures were performed worldwide, of which United States and largest European states accounted for roughly 46% and 37%, largest Asian states contributed 10.4% and the rest of the world added remaining 6.5%.

The 2014 global cerebral thrombectomy system sales were estimated at approximately $166 million, of which the United States accounted for about $79.1 million (or ~47.7%), followed by the largest Western European states with $59.4 million (or 35.8%), major Asian states with $17 million (or 10.2%) and the rest-of-the-world with $10.5 million (or 6.3% of the total).

In the view of the industry insiders and practicing neurointerventional radiologists, relatively modest volume of life-saving cerebral thrombectomy procedures and corresponding product sales appear to reflect still insufficient body of favorable clinical data and inhibiting impact of the published dubious findings from the major IMS-III study.

The latter compared first-generation cerebral thrombectomy techniques with standard medical (and tPA) therapy and asserted that endovascular clot retrieval interventions did not result in visible improvement in patient outcomes. The cited conclusions clearly contradict results of numerous randomized trials with available second-generation cerebral revascularization systems, which appear to documented superiority of the latter system in management of acute ischemic stroke caseloads.

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.

Based on these assumptions, the cumulative worldwide volume of cerebral thrombectomy procedures is projected to experience accelerated growth to the end of the forecast period resulting in 10.8% overall average annual expansion of corresponding interventions in the forthcoming five years to an estimated 56.2 thousand total procedures worldwide in 2019.

From: “Emerging Global Market for Neurointerventional Technologies in Stroke, 2014-2019”, Report #C310.

The worldwide market for cerebral clot retrieval systems is forecast to grow at a slightly slower pace expanding on average 10.1% per annum to about $268.4 million in the year 2019. Price pressure will keep sales growth lower than procedure volume gains.

The largest absolute dollar gains can be expected in the U.S. market (which is projected to add $55.9 million in corresponding device revenues), followed by the West European marketplace (+ $30.6 million), major Asian state business (+ $11.2 million) and the rest-of-the-world (+ $4.7 million).

Medtech Fundings in October 2016 Thu, 13 Oct 2016 19:56:46 +0000 Fundings in medical technology during the month of October 2016 stand at $262 million, led by the $75 million funding of AcuFocus, Inc.

The complete list of fundings for the month thus far is at link.


For a historical listing of fundings by month, see link.

Technologies at Recent Medtech Startups Thu, 13 Oct 2016 19:43:23 +0000 Continue reading "Technologies at Recent Medtech Startups"]]> Below is a list of the technologies under development at medical technology startups identified in October 2016 and included in the Medtech Startups Database:

  • Neuoro-stimulation via patch.
  • Epinephrine auto-injector
  • Portable ultrasound device to detect the occurrence of strokes.
  • Medication adherence device to facilitate self-injection.
  • Diagnosis of malaria and sickle cell.
  • Implant devices to fight biofilms and infection.
  • Technologies to address infection and other risk in nursing protocols.
  • Electronic bone depth gauge for use in orthopedics.
  • Peripheral chronic total occlusion device.
  • Deep learning and artificial intelligence in point of care ultrasound.
  • Quantitative transmission ultrasound.

A historical listing of technologies at medtech startups (through January 2016).

The Regimens for Assessing and Treating Wound Types Mon, 10 Oct 2016 18:53:53 +0000 Continue reading "The Regimens for Assessing and Treating Wound Types"]]> Wound treatment starts with diagnosis. Acute wounds are often surgically created, or dealt with in accident and emergency (A&E) settings. Diagnosis in the acute scenario usually focuses on cleanliness and tidying of the wound edges to enable securement using sutures or glue products. If major trauma has occurred, hemostats and sealants may be required. In the chronic scenario, diagnosis is a process that occurs at every treatment session. The practitioner will examine size, appearance and odor changes to the wound, and from this process determine the ideal management. In addition, it is likely that the physician will take samples to send for microbial assessment if infection becomes a concern.

Following diagnosis and assessment, treatment will be established based on known efficacy and cost of individual dressings, knowledge of the potential products that may be used, and their availability. This will be determined by reimbursement, local purchasing decisions, and resources.

For chronic wounds, treatment often involves symptoms; many products are designed to remove aesthetically unpleasant aspects of wounds such as exudates, smell, and visibility.

Management of exudates also has a wound-healing benefit. Too much exudate leads to hydrolytic damage and maceration of the tissue and surrounding skin. Too little moisture leads to drying out of the wound and cell death. As a result, many advanced wound management products have been developed to optimize the moist wound healing environment. As a huge variety of wound conditions arise, a large number of dressings has been developed to help manage the full range of circumstances that may be encountered. These include dressings made from foams, polyurethane films, alginates, hydrocolloids, and biomaterials to manage exudates, which may be present in vast quantities (perhaps as much as two liters per square meter per day). Other products are designed to moisten the wound to optimize healing (amorphous hydrogels for example).

Much of the advanced wound management market has evolved to improve exudates management in the home setting, in order to reduce the need for visits by practitioners and the associated cost.

Types and Uses of Select Wound Care Products

Dressing categoryProduct examplesDescriptionPotential applications
FilmHydrofilm, Release, Tegaderm, BioclusiveComes as adhesive, thin transparent polyurethane film, and as a dressing with a low adherent pad attached to the film.Clean, dry wounds, minimal exudate; also used to cover and secure underlying absorptive dressing, and on hard-to-bandage locations, such as heel.
Polyurethane foam dressing available in sheets or in cavity filling shapes. Some foam dressing have a semipermeable, waterproof layer as the outer layer of the dressingFacilitates a moist wound environment for healing. Used to clean granulating wounds which have minimal exudate.
HydrogelHydrosorb Gel Sheet, Purilon, Aquasorb, DuoDerm, Intrasite Gel, GranugelColloids which consist of polymers that expand in water. Available in gels, sheets, hydrogel-impregnated dressings.Provides moist wound environment for cell migration, reduces pain, helps to rehydrate eschar. Used on dry, sloughy or necrotic wounds.
HydrocolloidCombiDERM, Hydrocoll, Comfeel, DuoDerm CGF Extra Thin, Granuflex, Tegasorb, Nu-DermMade of hydroactive or hydrophilic particles attached to a hydrophobic polymer. The hydrophilic particles absorb moisture from the wound, convert it to a gel at the interface with the wound. Conforms to wound surface; waterproof and bacteria proof.Gel formation at wound interface provides moist wound environment. Dry necrotic wounds, or for wounds with minimal exudate. Also used for granulating wounds.
AlginateAlgiSite, Sorbalgon Curasorb, Kaltogel, Kaltostat, SeaSorb, TegagelA natural polysaccharide derived from seaweed; available in a range of sizes, as well as in ribbons and ropes.Because highly absorbent, used for wounds with copious exudate. Can be used in rope form for packing exudative wound cavities or sinus tracts.
AntimicrobialBiatain Ag
Atrauman Ag
Both silver and honey are used as antimicrobial elements in dressings.Silver: Requires wound to be moderately exudative to activate the silver, in order to be effective
V.A.C. Ulta
Renasys (not in USA)
Prospera PRO series
Invia Liberty
Computerized vacuum device applies continuous or intermittent negative or sub-atmospheric pressure to the wound surface. NPWT accelerates wound healing, reduces time to wound closure. Comes in both stationary and portable versions.May be used for traumatic acute wound, open amputations, open abdomen, etc. Seems to increase burn wound perfusion. Also used in management of DFUs. Contraindicated for arterial insufficiency ulcers. Not to be used if necrotic tissue is present in over 30% of the wound.
Bioengineered Skin and Skin SubstitutesAlloDerm, AlloMax, FlexHD, DermACELL, DermaMatrix, DermaPure, Graftjacket Regenerative Tissue Matrix, PriMatrix, SurgiMend PRS, Strattice Reconstructive Tissue Matrix, Permacol, EpiFix, OASIS Wound Matrix, Apligraf, Dermagraft, Integra Dermal Regeneration Template, TransCyteBio-engineered skin and soft tissue substitutes may be derived from human tissue (autologous or allogeneic), xenographic, synthetic materials, or a composite of these materials.Burns, trauma wounds, DFUs, VLUs, pressure ulcers, postsurgical breast reconstruction, bullous diseases

Source: MedMarket Diligence, LLC; Report #S251.

In some cases, the wound may be covered by a black necrotic tissue or yellow sloughy material. These materials develop from dead cells, nucleic acid materials, and denatured proteins. In order for new tissue to be laid down, this dead material needs to be removed. It may be done using hydrolytic debridement using hydrogels that soften the necrotic tissue, or by the use of enzymes. Surgical debridement is another option, but non-surgical debridement has the advantage that it is usually less painful and can be performed with fewer materials, less expertise, and less mess. It is possible to perform non-surgical debridement in the home setting. Debridement can also be performed to selectively remove dead tissue and thus encourage repair. Enzymatic debriders have been able to command a premium price in the market, and built a sizeable share of the wound management market, particularly during the 1990s when treatment in the home environment increased as a result of reductions in hospital-based treatment. These products are described in the section on cleansers and debriders.

Occasionally healthcare practitioners put maggots to work for wound debridement. Though esthetically unpleasant, maggots are very effective debriding agents because they distinguish rigorously between dead and living tissue. Military surgeons noticed the beneficial effect of maggots on soldiers’ wounds centuries ago, but maggot debridement therapy (MDT) as it is practiced today began in the 1920s and has lately been undergoing something of a revival. The maggots used have been disinfected during the egg stage so that they do not carry bacteria into the wound. The larvae preferentially consume dead tissue, they excrete an antibacterial agent, and they stimulate wound healing.

At the other end of the technological scale are skin substitutes, which have been developed to help in the management of extensive wounds such as burns. Autologous skin grafting is a well-established therapeutic technique; postage-stamp-sized sections of healthy skin are cultured and grown in vitro, then placed over the raw wound surface to serve as a focus for re-epithelialization. However, this process takes time; the wound is highly vulnerable to infection while the skin graft is being grown. A number of companies have developed alternatives in the form of synthetic skin substitutes. These are described further in the next section of the report.

A number of products have also been developed to deal with sloughy and infected wounds. These often incorporate antimicrobial agents. Often, infected wounds have a very unpleasant odor; a range of odor control dressings has arisen to deal with this.

Once wounds begin to heal, the amount of exudate starts to decrease. Some dressing products preserve moisture but are also non-adhesive, so that the dressing does not adhere to the new epithelializing skin. These products are called non-adherent dressings and include a range of tulle dressings, which usually consist of a loose weave of non-adherent fabric designed to allow exudates to pass through the gaps. A subgroup of dressings is designed to keep the skin moist in order to reduce scarring after healing.

For wounds that do not appear to be healing, a number of companies have explored the potential to add growth factors and cells to promote and maintain healing. In addition, companies have attempted to use energy sources to accelerate wound healing, and these are described in the section on physical treatments. The main example of physical treatment is the use of devices which apply negative pressure over the wound and have been shown to dramatically shorten the healing of diabetic ulcers and other chronic wounds.

Often, a dressing will serve more than one purpose. Therefore, it is difficult to generalize and collect only dressings that serve one purpose into a single category. For example, Systagenix’s Actisorb Plus (Systagenix is now owned by Acelity) is a woven, low-adherent odor control antimicrobial dressing designed to optimize moist wound healing through its exudates handling properties.

From, Worldwide Wound Management, Forecast to 2024MedMarket Diligence, LLC.

Cardiac Rhythm Disorders and Implantable, Device-based Treatments Thu, 06 Oct 2016 14:16:04 +0000 Continue reading "Cardiac Rhythm Disorders and Implantable, Device-based Treatments"]]> Cardiac rhythm disorders, also called arrhythmias or dysrhythmias, encompass a variety of relatively common acute and chronic conditions characterized by recurrent distortions in the electrical and contractile activity of the heart, which may cause clinically significant and progressive hemodynamic deficits and cardiopulmonary impairment.

According to the available statistics from the American Heart Association (AHA) and Heart Rhythm Society, symptomatic cardiac arrhythmias effect over 10 million Americans and account for approximately 20% of all chronic conditions treated by cardiologists in the United States.

The rate and rhythm of the heart are determined by the intrinsic rhythmicity of special tissues and structures within the heart wall muscle generated by the heart’s natural electrophysiological mechanism. Normal cardiac rate and rhythm ensure continued uninterrupted blood flow an associated supply of oxygen and nutrients to the brain and other vital organs. Irregularities in the rate, rhythm, or origin of a stimulus leading to myocardial contraction can potentially interrupt normal blood circulation, causing inadequate function of important body systems, stroke or sudden cardiac arrest and death. Heart pacing disorders usually degenerate and worsen over time.

Although cardiac arrhythmias may be triggered by congenital heart defects, in which the electrical system of the heart does not develop properly, non-congenital heart disorders are believed to be the most common causes of chronic arrhythmias. The latter is particularly true for ischemic heart disease, which results in reduced blood flow and oxygen delivery to heart tissue, and heart tissue scarring typically caused by myocardial infarction. Other causes of arrhythmia include abnormal blood and tissue concentrations of certain minerals; abnormalities of the autonomic nervous system, which is involved in cardiovascular regulation; stress; and use of alcohol, caffeine, illicit drugs, and tobacco, as well as diet pills and some other medications.

Cardiac arrhythmias are generally categorized according to their impact on heart rates. Bradycardia is an abnormally slow resting heart rate, whereas tachycardia is an abnormally high resting heart rate. Bradycardias are most commonly associated with SA node disease and/or various forms of heart block.

Tachycardias are usually classified by their origination site and may be subdivided into two broad categories, specifically, supraventricular tachycardias (SVTs) and ventricular tachycardias (VTs).

Below are shown the projected implantable pump generator placements by region from 2015 to 2022. These include pacemaker placements, implantable cardioverter defibrillator placements, and cardiac resynchronization therapy placements.


Source: MedMarket Diligence LLC (Report #C500).

Requirements for acceptance of new peripheral stents in clinical practice Tue, 04 Oct 2016 18:43:59 +0000 Continue reading "Requirements for acceptance of new peripheral stents in clinical practice"]]> Stents are implantable devices designed as endoluminal scaffolds to maintain patency following recanalization of occluded or structurally compromised vascular (and non-vascular) circulatory conduits that enable energy supply and metabolic exchange in various organs and tissues of the human body. Palliative stenting has been routinely used for decades in the management of acute and chronic obstructions of gastro-intestinal, pulmonary and urinary tracts secondary to benign or malignant neoplasms or other cite-specific or systemic pathologies. However, a real explosion in utilization of stents was triggered in the early 1990s by the advent of vascular stenting devices, which allowed radically improved clinical outcomes of balloon angioplasty and supported its emergence as the first choice treatment modality for occlusive peripheral and coronary artery disease (PAD and CAD). By the end of 2014, more than three quarters of patients with acute and chronic arterial occlusions warranting intervention were referred for angioplasty-based therapy, which entailed placement of stenting devices in over 80% of commonly performed peripheral revascularization procedures.

To be accepted in clinical practices, stenting implants should satisfy a number of general and application-specific requirements relating to device biocompatibility, functional performance, and end-user and patient friendliness which are summarized in the exhibit below. In very general terms, stenting device biocompatibility refers to minimization of hostile immune responses (and other local and systemic adverse reactions) that are inevitably triggered by a direct contact of any implantable medical device with living tissues and bodily fluids in situ. For understandable reasons, biocompatibility depends primarily on the implant surface material, including such characteristics as chemical inertness and stability, corrosion resistance, etc. The stenting device biocompatibility can also be effected somewhat by the duration of its presence in situ and specifics of the deployment site and occlusion causing pathology.

The stent’s functional performance (or ability to maintain adequate scaffolding support and lumen patency for a desired period of time) represents a complex function of the device design/architecture and the relative static and dynamic strength of its base material. The chosen stenting device’s architecture and structural material predetermine it radial strength, longitudinal flexibility, conformability and foreshortening, as well as relative lesion coverage, fatigue and kinking resistance, circulatory flow obstruction, etc.

Finally, the stent’s end-user and patient friendliness are predicated both by the design concept of the delivery system and stenting device and refers to procedural convenience, predictability, safety, morbidity, availability of bail-out options, etc. The commonly acknowledged stenting system characteristics relating to the end-user/patient friendliness include low profile, flexibility, traceability, high radiopacity, compatibility with established transcatheter tools and techniques, ease of use and short learning curve, simplicity of retrieval in case of procedural failure, possibility of emergent /elective conversion to surgery, etc.

Selected Biomedical, Clinical and Technical Requirements
for Stenting Implants


Source: MedMarket Diligence, LLC; Report #V201.

Wound management is highly fragmented and competitive Tue, 04 Oct 2016 13:15:37 +0000 Continue reading "Wound management is highly fragmented and competitive"]]> The wound care industry is highly fragmented, with around eight large companies leading the pack, but with hundreds—some say thousands—of small cap companies also manufacturing and marketing wound care products. The space is attractive, because even small companies can experience a sudden rise in market share and profits if they are able to develop a medical manufacturing breakthrough.


Source: Report #S251.

This market has a low level of concentration, meaning that no single global company, a list that includes Johnson & Johnson, Acelity LP, Inc., 3M Health Care and Smith & Nephew, dominates the market. Another half-dozen manufacturers have less than 10% market share, while ‘Others,’ which represents the hundreds of additional companies active in this space, accounts for the largest share of the wound care market. The field is crowded and highly fragmented. Barriers to entry vary by product, with the traditional segments having relatively low barriers to entry, while Growth Factors, for example, requires the potential manufacturer to possess specific, highly-technical information and physical equipment in order to enter the field.

To take a couple of examples of the high density of manufacturers in these product segments, the Foam Dressings segment includes 3M, B. Braun, BSN Medical, Coloplast, ConvaTec, Covalon Technologies, Medtronic, Derma Sciences, Hartmann Group, Hollister and many more. In the multimillion dollar NPWT industry, key players include Smith & Nephew, wound care specialists Kinetic Concepts (KCI, now owned by Acelity LP, Inc.), Prospera, Talley Group Ltd, Convatec, Mölnlycke Health Care AB, ArjoHuntleigh Healthcare Ltd, Medela, Inc., and Genadyne.

From, “Wound Management, Forecast to 2024: Established and Emerging Products, Technologies, and Market in the Americas, Europe, Asia/Pacific, and Rest of World.” Report #S251.

Coronary and venous interventions show inevitable Asia/Pacific dominance Mon, 03 Oct 2016 18:54:35 +0000 Continue reading "Coronary and venous interventions show inevitable Asia/Pacific dominance"]]> Coronary revascularization, whether by bypass graft or percutaneous coronary intervention, drives an enormous amount of medtech business. Angioplasty catheters, guidewires, and the plethora of devices in cardiothoracic surgery represent many millions in sales annually. Manufacturers pursuing growth in these areas will see big, but slowing growth rates in the U.S., while markets in Asia/Pacific reflect the growing demand for cardio technologies. Already, these markets are surpassing western markets:


Source: Report #C500.

While coronary applications have a long history, venous interventions have less, and procedure data shows that patient populations have not been fully tapped in any geographic region. Already, Asia/Pacific markets would appear to be on course to eclipse western markets, but not until after 2022, and will eclipse Western Europe markets before challenging the U.S.


Source: Report #C500.

Materials used in sealants, glues, and hemostats Mon, 03 Oct 2016 03:49:16 +0000 Continue reading "Materials used in sealants, glues, and hemostats"]]> Sealants are most often used to stop widespread, diffuse internal bleeding. The product may be sprayed on a bleeding surface, or applied internally using a patch. Sealants are considered inappropriate for heavy bleeding. Surgical sealants may be made of glutaraldehyde and bovine serum albumin, polyethylene glycol polymers, and cyanoacrylates. Fibrin sealants are made of a combination of thrombin and fibrinogen. Sealants may also be made from a patient’s blood (autologous), which limits immunological and other risks.

Although the terms ‘glues’ and ‘adhesives’ are frequently used interchangeably, medical glues are products used to make two tissue surfaces adhere securely to each other without coming apart under normal physical stress. The definition of medical glues does not include medical adhesives such as those coating a bandage to make it stick to the skin.

A hemostat is commonly used in both surgery and emergency medicine to control bleeding, such as from a torn blood vessel. Active hemostats contain thrombin products which may be derived from several sources, such as bovine pooled plasma purification, human pooled plasma purification, or through human recombinant manufacturing processes. Flowable-type hemostats are made of a granular bovine or porcine gelatin that is combined with saline or reconstituted thrombin, forming a putty that may be applied to the bleeding area. Mechanical hemostats, which generally require pressure to stop the bleeding, include items such as hemostatic clamps, absorbable gelatin sponge, collagen, cellulose, or polysaccharide-based hemostats applied as sponges, fleeces, bandages, or microspheres, and do not contain thrombin or any other active biologic compounds.

Global Market for Wound Sealants, Glues and Hemostats, 2015-2022


Source: “Worldwide Markets for Medical and Surgical Sealants, Glues, and Hemostats, 2015-2022.” (report #S290.)

Coronary and Peripheral Vascular Dominate Global Cardiovascular Procedure Volumes Wed, 28 Sep 2016 15:09:58 +0000 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).


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

Global and Regional Cardiovascular Surgical and Interventional Procedures Forecast; Reveals Cardio Tech Outlook Thu, 22 Sep 2016 03:11:10 +0000 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


Medtech Fundings for September 2016 Thu, 15 Sep 2016 20:09:52 +0000 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.


Source: Compiled by MedMarket Diligence, LLC.

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

Wound management practice patterns, products by wound type Tue, 13 Sep 2016 14:32:32 +0000 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”.

Eight Sectors of Cardiovascular Surgery Reveal Growth, Volume to 2022 Fri, 09 Sep 2016 20:39:25 +0000 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.


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.

Growth of Lower Extremity Angioplasty with Drug-Coated Balloons Tue, 06 Sep 2016 22:32:51 +0000 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.

Source: Report #C500.

]]> 9672 Fixing congenital heart defects on a global scale Wed, 31 Aug 2016 20:09:24 +0000 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%.

For the period 2015 to 2022, 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.).

Upside from innovation, emerging markets for sealants, glues, hemostats Tue, 30 Aug 2016 07:10:42 +0000 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.
The Five Highest Growth Cardiovascular Procedures Mon, 22 Aug 2016 15:45:32 +0000 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.



Endovascular Repair of TAA and AAA Thu, 18 Aug 2016 21:34:03 +0000 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.


See link.

]]> 9627 The future of cardiovascular medicine Wed, 17 Aug 2016 06:22:09 +0000 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.