This is an excerpt from Report #C500, “Cardiovascular Procedures to 2022.”
Cardiovascular Procedures in 2016
• 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, the cumulative worldwide volume of the most prevalent cardiac surgeries and other cardiovascular procedures (at right) is projected to approach 15.05 million surgical and transcatheter interventions. This will include:
in coronart artery disease, roughly 4.73 million coronary revascularization procedures via coronary artery bypass graft (CABG) and percutaneous coronary intervention (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 chronic venous insufficiency, deep vein thrombosis, and pulmonary embolism targeting venous interventions (representing 11.0% of the total);
more than 992 thousand surgical and transcatheter heart defect repairs and valve replacement or valve repair (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 period 2016 to 2022, 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.
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.
Report #C500: “Global Dynamics of Surgical and Interventional Cardiovascular Procedures, 2015-2022.” Request excerpts.
This report may be purchased for immediate download at link.
Market shares for sales of sealants, glues, and hemostats vary considerably from region to region globally due to the significant variations in the local market demand, rate of adoption of specific manufacturers’ products, the regulatory climate, local economies, and other factors. Consequently, manufacturers with significant share of sales in the U.S. or Europe or Asia/Pacific may have considerably lower or higher shares in other regions.
In the U.S., Ethicon and Baxter have dominant positions in sales of surgical sealants. However, in Europe and Asia/Pacific, Baxter has substantially smaller position, particularly relative to competitors like Takeda Pharmaceuticals and The Medicines Company.
In the market for hemostats, similarly, Ethicon and Baxter have dominant position in the U.S. market, but in Asia/Pacific and Europe, Baxter is subordinate to Takeda Pharmaceuticals, CryoLife, and others.
Medtech fundings for March 2017 totaled over $2 billion, led by the $1.2 billion raise by ConvaTec, the $59 million IPO of Symetics, the $50 million Series C funding of Moximed, the $45 million funding of Corindus, and the $40 million funding round of VertiFlex.
The complete list of fundings in medtech for March 2017 are shown at link. Below are the top fundings for the month.
Source: Compiled by MedMarket Diligence, LLC
For a historical list of fundings by month since 2009, see link.
The nature of graphene’s structure and its resulting traits are responsible for a tremendous burst of research focused on applications.
Find cancer cells. Research at the University of Illinois at Chicago showed that interfacing brain cells on the surface of a graphene sheet allows the ability to differentiate a single hyperactive cancerous cell from a normal cell. This represents a noninvasive technique for the early detection of cancer.
Graphene sheets capture cells efficiently. In research similar to that U. Illinois, modification of the graphene sheet by mild heating enables annealing of specific targets/analytes on the sheet which then can be tested. This, too, offers noninvasive diagnostics.
Contact lens coated with graphene. While the value of the development is yet to be seen, researchers in Korea have learned that contact lenses coated with graphene are able to shield wearers’ eyes from electromagnetic radiation and dehydration.
Cheaply mass-producing graphene using soybeans. A real hurdle to graphene’s widespread use in a variety of applications is the cost to mass produce it, but Australia’s CSIRO has shown that an ambient air process to produce graphene from soybean oil, which is likely to accelerate graphenes’ development for commercial use.
Advanced materials development teams globally are spinning out new materials that have highly specialized features, with the ability to be manufactured under tight control.
3D manufacturing leads to highly complex, bio-like materials. With applications across many industries using “any material that can be crushed into nanoparticles”, University of Washington research has demonstrated the ability to 3D engineer complex structures, including for use as biological scaffolds.
Hydrogels and woven fiber fabric. Hokkaido University researchers have produced woven polyampholyte (PA) gels reinforced with glass fiber. Materials made this way have the structural and dynamic features to make them amenable for use in artificial ligaments and tendons.
Sound-shaping metamaterial. Research teams at the Universities of Sussex and Bristol have developed acoustic metamaterials capable of creating shaped sound waves, a development that will have a potentially big impact on medical imaging.
In vitro testing models that more accurately reflect biological systems for drug testing and development will facilitate clinical diagnostics and clinical research.
Stem cells derived neuronal networks grown on a chip. Scientists at the University of Bern have developed an in vitro stem cell-based bioassay grown on multi-electrode arrays capable of detecting the biological activity of Clostridium botulinum neurotoxins.
Used for mimicking heart’s biomechanical properties. At Vanderbilt University, scientists have developed an organ-on-a-chip configuration that mimics the heart’s biomechanical properties. This will enable drug testing to gauge impact on heart function.
Used for offering insights on premature aging, vascular disease. Brigham and Women’s Hospital has developed organ-on-a-chip model designed to study progeria (Hutchinson-Gilford progeria syndrome), which primarily affects vascular cells, making this an affective method for the first time to simultaneously study vascular diseases and aging.
I found this article on anti-vaxxers worthwhile, given what I know and my interest in the subject. Science should have no agenda but furthering knowledge and the effort to improve our lives on this planet.
Today’s surgeon has a broad range of products from which to choose for closing and sealing wounds. These include sutures, stapling devices, vascular clips, ligatures, and thermal devices, as well as a wide range of topical hemostats, surgicalsealants and glues.
However, surgeons still primarily use sutures for wound closure and securement—sutures are cheap, familiar and work most of the time. Now, in addition to reaching for a stapling device, the surgeon must frequently decide at what point to augment or replace the commonly used items in favor of other products, which product is best for what procedure or condition, how much to use, and ease of use in order to achieve optimal patient outcomes. Because of budget pressures, the surgeon must also consider price when selecting a product. Of course in the USA, the product must also be FDA-approved, although the surgeon still has the choice of using a product off-label.
In the areas of sealants, hemostats and glues, there is room for both improvement and additional products. There are a number of products already on the market, but the fact is that there is no one product that meets all needs in all situations and procedures. There are few products that stand out from the rest, apart, perhaps, from DermaBond® and BioGlue®. There are unmet needs, and companies having the necessary technology, or which may acquire and further develop the technology, can enter this market and launch novel items. These products have yet to significantly tap the potential for wound management and medical/surgical procedures.
Note: Log10 scale; Chronic wounds includes pressure, venous/arterial and diabetic ulcers.
Numerous variants of fibrin sealant exist, including autologous products. “Other” sealants refers to thrombin, collagen & gelatin-based sealants.
Fibrin sealants are used in the US in a wide array of applications; they are used the most in orthopedic surgeries, where the penetration rate is thought to be 25-30%. Fibrin sealants can, however, be ineffective under wet surgical conditions. The penetration rate in other surgeries is estimated to be about 10-15%.
Fibrin-based sealants were originally made with bovine components. These components were judged to increase the risk of developing bovine spongiform encephalopathy (BSE), so second-generation commercial fibrin sealants (CSF) avoided bovine-derived materials. The antifibrinolytic tranexamic acid (TXA) was used instead of bovine aprotinin. Later, the TXA was removed, again due to safety issues. Today, Ethicon’s (JNJ) Evicel is an example of this product, which Ethicon says is the only all human, aprotinin free, fibrin sealant indicated for general hemostasis. Market growth in the Sealants sector is driven by the need for improved biocompatibility and stronger sealing ability—in other words, meeting the still-unsatisfied needs of physician end-users.
High Strength Medical Glues
Similar to that of sealants, the current market penetration of glues in the US is about 25% of eligible surgeries. There are several strong points in favor of the use of medical glues: their use can significantly reduce healthcare costs, for example by reducing time in the surgical suite, reducing the risk of a bleed, which may mean a return trip to the OR, and general ease of use. Patients seem to prefer the glues over receiving sutures for external wound closure, as glues can provide a suture-free method of closing wounds. In addition, if glues are selected over sutures, the physician can avoid the need (and cost) of administering local anesthesia to the wound site.
Hemostats are normally used in surgical procedures only when conventional methics to stop bleeding are ineffective or impractical. The hemostat market offers opportunities as customers seek products that better meet their needs. Above and beyond having hemostatic agents that are effective and reliable, additional improvements that they wish to see in hemostat products include: laparoscopy-friendly; work regardless of whether the patient is on anticoagulants or not; easy to prepare and store, with a long shelf life; antimicrobial; transparent so that the surgeon continues to have a clear field of view; and non-toxic; i.e. preferably not made from human or animal materials.
Drawn from, “Worldwide Markets for Medical and Surgical Sealants, Glues, and Hemostats, 2015-2022: Established and Emerging Products, Technologies and Markets in the Americas, Europe, Asia/Pacific and Rest of World.”Report #S290.
In past posts, we have reported on multiple naturally-occurring substances or methods for strong adhesion that are being investigated for their potential to be exploited for medical or surgical adhesion. These include adhesives from remora, mussels, geckos, crab shells, barnacles, Australian burrowing frogs, spider webs, porcupine quills, sandcastle worms, etc.
Researchers from MedUni Vienna and Vienna University of Technology are now investigating 300 different ticks for the “cement” used by the parasites to attach to hosts. The goal is to study the composition of the natural tick “dowel” used by the mouthparts of ticks and determine how it might serve as a template for new tissue adhesives.
The Vienna research also notes other natural adhesives are similarly being investigated for medical and surgical use:
Other potential “adhesive donors” are sea cucumbers, which shoot sticky threads out of their sac; species of salamander, which secrete extremely fast-drying adhesive out of skin glands, if attacked; or insect larvae, which produce tentacles or crabs, which can remain firmly “stuck,” even under water.
The incentive for studying natural adhesives is that they have been driven by evolution to provide strong adhesion without toxicity in various wet or dry conditions that are challenging for existing synthetic or existing natural glues (e.g., fibrin glues, cyanoacrylates, etc.). Surgical glues currently in use have some limitation arising from lesser strength, ease of use, toxicity, and other shortcomings. New glues will gain wider adoption, capturing procedure volume used with sutures, clips and other closure methods, particularly in internal use, if they are stronger and/or provide tighter seals (without needing to be combined with sutures on the same incision/wound) and do not cause the toxicity that some high strength medical glues do (e.g., synthetics like cyanoacrylates; “super glues”). The biologically-derived glues (or the surfaces structures of gecko feet) avoid the toxicities of synthetics and have often proven to have very high tensile strength. (The fast-curing cement used by barnacles has been shown to have a remarkable tensile strength of 5,000 pounds per square inch.)
MedMarket Diligence tracks the technologies, clinical practices, companies, and markets associated with medical and surgical sealants and glues, with the most recent coverage in, “Worldwide Markets for Medical and Surgical Sealants, Glues, and Hemostats, 2015-2022,” (report #S290).
The bulk of medical/surgical glues are biologically-based, and soon the bulk of medical glue sales will come from Asia/Pacific.
The two graphs below show the changes in regional shares in biologically-based glues. It can be seen that from 2015 to 2022, the US and Asia-Pacific will practically switch places in terms of revenue share per region. This significant change will come about because of the intensive and enormous healthcare modernization taking place in the PRC. In 2012, the Chinese government announced its 12th five-year plan which includes the construction of 20,000 new hospital and healthcare facilities.
Source: Worldwide Markets for Medical and Surgical Sealants, Glues, and Hemostats, 2015-2022: Established and Emerging Products, Technologies and Markets in the Americas, Europe, Asia/Pacific and Rest of World (Report #S290).
Below is an excerpt from, “Global Dynamics of Surgical and Interventional Cardiovascular Procedures, 2015-2022,” (Report #C500 described, available online).
Selection of specific management protocols for patients with aortic aneurysms depends on the disease morphology as well as patient’s age, overall health status, and comorbidities involved. In cases involving smaller and relatively stable abdominal or thoracic aortic aneurysm (AAA or TAA), watchful waiting represents a commonly preferred approach. Radical surgical or endovascular interventions are generally reserved for cases when the diameter of the aneurismal sac is larger than 5cm to 5.5cm, or the annual expansion rate exceeds 1.0 cm, or when the aneurysm becomes symptomatic.
Surgical Repair of Aortic Aneurysms
Prior to the advent of AAA/TAA endovascular repair tools and techniques, a highly invasive and risky surgical repair procedure constituted the only curative option for patients with advanced and rupture prone aortic aneurysm. Conducted under the general anesthesia the procedure takes a few hours and entails a major and highly traumatic operation with a 10-15 inch cut in abdominal wall, clamping and isolation of aneurysmic segment of aorta, incision into the aneurysm, evacuation of the clot contained within, placement of a synthetic graft, and wrapping of the graft with remnants of the aortic wall.
The typical surgical aneurysm repair is associated with a substantial (5% to 8%) mortality rate and serious complications, such as stroke, myocardial infarction, renal failure etc.
Due to the close proximity to the heart, the risk and complication rates of surgical intervention for aneurysm repair on the thoracic aorta increase multifold resulting in an average procedural mortality rate of up to 30 percent.
The high cost of the procedure is largely the result of extended ICU and hospital stays, which can last upwards of a week (but average roughly 10-12 days). Further, postoperative recovery may require up to six additional weeks subsequent to discharge, making temporary disability a major consideration for many patients.
Notwithstanding these drawbacks, open surgical aortic aneurysm repair is still commonly regarded as highly effective treatment modality that virtually eliminates the risk of aneurismal sac rupture and does not require extensive postoperative follow-up exams or revisions.
However, because of high prevalence of elderly and health-impaired persons in diagnosed aortic aneurysm caseloads and traumatic nature of AAA/TAA surgery, only a fraction of the patients who could benefit from surgical aneurysm repair is deemed eligible for such a procedure.
Abdominal Aortic Aneurysm Repair with Endovascular Stent-Grafts
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.
Limitations of Endovascular AAA Repair
Findings from numerous clinical studies and real-life experience in the field seem to indicate that endovascular aortic aneurysm repair via stent-graft placement tends to provide immediate procedural outcomes comparable to these obtainable with open surgery. Furthermore, the typical ICU and hospital stay for endovascular AAA repair averages 2 days (though it may last twice longer for patients with significant comorbidities). All of these translates into reduced inpatient costs of AAA repair relative to open surgery, although the high price of stent-grafting devices largely offsets these cost savings. Post-discharge recovery is also shortened from weeks or months to an average 7-10-day period.
Unfortunately, comparative long-term clinical efficacy and cost-effectiveness of the endovascular approach to aortic aneurysm repair appears to be problematic due to unavoidable shortcomings of available aortic stent-graft designs and complications associated with their less than perfect performance in situ.
The major problems associated with the endovascular AAA repair approach include relatively high incidence of endoleaks (up to 15%), endotension, and device failure, which multiply the risk of catastrophic aneurysm rupture and necessitate costly revisions (in up to 35% of the cases) as well as long-term (or life-long) patient surveillance (with mandatory imaging exams). Due to that, the actual overall cost of endovascular repair in many considerably exceeds expenses incurred in traditional open surgery.
Another limitation of endovascular stent-grafting relates to its ability to accommodate complex aortic aneurysm morphology and branch involvement. Based on some end-user and industry reporting, only about 50% of patients that develop intervention-warranting AAAs are considered good candidates for endovascular repair with currently available product configurations.
According to some recent reporting, endovascular aneurysm repair (EVAR) treatment with certain stent grafts also appears to be associated with higher late mortality rates (due to aneurysm rupture) compared to surgical AAA repair. Based on available long-term follow-up data, mortality in AAA patients retrofitted with the market-leading SG averages 1.3% and 1.5% at four and five years compared to 0.7% and 0.9% for AAA surgery.
Endovascular Repair of TAA
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.
Aortic Aneurysm Repair Procedure Volumes
Based on the industry reporting, national and international healthcare authority data, and MedMarket Diligence estimates, in 2015, approximately 915 thousand patients worldwide were diagnosed with rupture-prone abdominal or thoracic aortic aneurysms and aortic dissections warranting radical intervention, of which roughly 359.5 thousand (or about 39.3%) were actually referred for surgical or transcatheter treatment. Covered APAC market geography (with combined population of about 2,63 billion) accounted for the largest 37.6% share of all aortic aneurysm repairs performed, followed by the U.S. with 25.6%, largest Western European states with 21.3% and the rest-of-the-world with the remaining 15.5%.
Endovascular stent-grafting techniques were utilized in approximately 162.5 thousand aortic aneurysm repair procedures in 2015, which included an estimated 133 thousand AAA-related and about 29.5 thousand TAA-related interventions (including these targeting selected thoracic aortic dissections).
The cited figures reflected a disparity both in the relative volumes of treated AAA and TAA patients and, especially, in the share of these managed with the less invasive EVAR techniques. The latter indicator was the highest for the U.S. (~75%), compared to 52% for Western Europe, 39% for APAC and only 36.6% for the ROW market geography.
During the forecast period covered in the report, the total global volume of endovascular aortic aneurysm repairs is projected to grow 5.7% per annum to approximately 243 thousand procedures, combining a 5.5% annual expansion in AAA-related interventions with a 6.6% average annual increase in TAA (aortic dissection)-related interventions.
Projected healthy gains in endovascular aortic aneurysm repair procedures should reflect continuous penetration of non-surgical (no option) AAA and TAA patient caseloads, coupled with significant incursion into surgery-eligible patient subsets both in AAA, TAA, and aortic dissection indications. Increasing reliance on utilization of less traumatic AAA and TAA stent-grafting techniques will be expedited by ongoing qualitative improvements in the endograft and delivery tools design that keep yielding more reliable, durable, versatile, and end-user friendly systems with reduced propensity to mechanical and functional failure (device kinking, fracture, endoleaks, migration, etc.) and associated clinical complications.
The largest relative gains in AAA and TAA EVAR procedures (10.9% and 11.8%, accordingly) can be expected in covered APAC territories (mostly China and India) and grossly underserved ROW zone (6.5% and 7.5%). Largely mature U.S., Western European (and Japanese) markets are likely to register a low single digit advances in utilization of endovascular AAA/TAA repair techniques.
The global procedure volume forecast for aortic aneurysm repair is presented below.
Projected Dynamics of Aortic Aneurysm Repair Procedures, World Total, 2015-2022 (#000)
Medtech fundings for February 2017 stand at $500.4 million, led by the $75 million credit facility secured by BioDelivery Sciences, the $45 million private placement by Corindus Vascular Robotics, the $41 million funding of Rhythm, Inc., the $37.2 million funding of Entellus Medical, and the $33 million funding of startup Surrozen.
Below are the top fundings for the month. For a complete list of fundings, see link.
Source: Compiled by MedMarket Diligence, LLC
For a historical listing of fundings in medtech, see link.