MedMarket Diligence is publishing within the next two weeks its 2016 report on peripheral stents for arterial and venous applications. The report is entitled, “Global Market Opportunities in Peripheral Arterial and Venous Stents, Forecast to 2020”, and is described in detail at link.
Over the past two decades, one could witness the advent and significant expansion of the neurointerventional armamentarium targeting management of acute stroke. In mid-1990s, endovascular coiling embolization tools and techniques for treatment of cerebral aneurysms and AVMs (arterio-venous malformations) were introduced as a less invasive alternative to craniotomy-based surgery in primary prevention of hemorrhagic stroke. Several years later, these techniques were supplemented with coil-containing stents, which enabled treatment of large, giant, and wide-neck aneurysms. The latter was followed by the launch of stent-based flow diversion systems, which allowed clinicians to hemoisolate such aneurysms without tedious and risky coil packing of the rupture-prone aneurysmal sac.
In primary ischemic stroke prevention, development of embolically-protected carotid stenting and left atrial appendage closure techniques provided clinicians with an option of using non-inferior transcatheter tools instead of customary surgical interventions.
Finally, a recent launch of the novel stent-based cerebral thrombectomy systems manifested a qualitative breakthrough in emergent treatment of acute cerebral ischemia, where marginally effective and severely caseloads restrictive intravenous tPA therapy represented the only available therapeutic option.
Presently, endovascular techniques are increasingly seen and used by practicing clinicians as preferred therapeutic modalities in prophylaxis and treatment of acute stroke and are likely to expand their role in the years to come.
Based on the industry reporting and other estimates, in 2014, approximately 227.3 thousand cerebral endovascular therapeutic procedures were performed worldwide. Prophylaxis of ischemic stroke via carotid artery stenting and left atrial appendage (LAA) closure with contributed 91.2 thousand and 11.9 thousand interventions (or 40.1% and 5.2%, accordingly), followed by transcatheter embolization of intracranial aneurysm and AVM for hemorrhagic stroke prevention with 90.5 thousand interventions (or 39.8%), and cerebral thrombectomy-based emergent treatment of acute cerebral ischemia with 33.7 procedures (or 14.8% of the total).
Geographically, Western Europe and the U.S. accounted for the largest shares of corresponding cerebrovascular interventions in 2014, with 35.7% and 35.0%, accordingly, followed by major APAC states with 19% and rest-of-the-world with the remaining 10.3% of the total procedures performed.
In a relatively classic scenario, established technologies have seen a loss of their once-premium pricing while emerging technologies are able to command an increasing premium as reward for their sophistication.
The worldwide coronary stent market is following the predicted course. Bare metal stents have been on the market for more than a decade and have, for six years, been overshadowed in the market by their more sophisticated drug-eluting competitor. The prices for these products have already bottomed out, with additional price erosion coming as a result of the general and sustained pressure on medical product prices.
The high prices commanded by drug-eluting stents have seen, and will see, a steeper decline as a result of increased competitiveness among market participants, the general downward pressure on prices for all medical products and, more significantly in the near-term, the advent of a new stent variant, the bioabsorbable stent.
Bioabsorbale stents are poised to command the prices once claimed by drug-eluting stents, due to their ability to further improve on outcomes in maintaining lumen patency, avoiding the need for repeat interventions and minimizing the likelihood of late stage thrombosis or other complications of stents.
The great unknown in the chart above is the impact of healthcare reform, the trend in medtech investment and the degree of severity in pricing pressures over this period. However, we anticipate that many or most of the initial, most significant effects of these forces will be felt in the 2010-2012 time frame. It may then only be the starting point (up or down) at which the above trends play out.
MedMarket Diligence has published, "Worldwide Market for Drug-Eluting, Bare Metal and Other Coronary Stents, 2008-2017." See link.
Dr. Julio Palmaz, who with Dr. Richard Schatz patented the balloon-expandable stent, believes that, while the market for stents has evolved from bare metal stents to drug-eluting stents (DES), the inevitable limitation of DES will be that they lead to inflammatory response and that their real drawback is that they create a barrier between tissue and the metal of the stent itself.
A plenary speaker during the XXX Congresso Nazionale Della Societa Italiana Di Cardiologia Invasiva (GISE), Dr Julio Palmaz (University of Texas Health Science Center, San Antonio) predicted that coatings "of any kind" will prove to be the downfall of drug-eluting stents—even the bioerodable polymers or the coatings used on fully bioerodable stents that today represent the next great hope in DES technology. Pointing to the failure of gold-coated stents back in 2000, Palmaz called on stent manufacturers to "learn from the mistakes of the past."
"Any coating, of any kind, will have the potential to [produce] nonspecific inflammatory changes," he predicted.
Dr. Palmaz pointed out that, in a bare metal stent, the positive charges of the metal cause the natural formation of oxides that induce healing. The problem with first generation metal stents, he says, is that the constructions of the stents, and their deployment, cause an interruption of the smooth metal surface that lead to an "unhappy" environment surrounding the stent, leading to restenosis. Dr. Palmaz's focus now, through his own company, is to engineer "advanced metallurgical surface technologies" that address this.
PRLog (Press Release) – Sep 09, 2009 – The global market for coronary stents is owned largely by drug-eluting stents (DES), but the size of the patient pool, the drive for lowered cost, ever-increased efficacy and less trauma are spawning the development of multiple new technologies in coronary stents and competitive anti-restenosis technologies. The global market, products, companies, trends and opportunities are the subject of the 2009 report, "Worldwide Coronary Stents 2009," from MedMarket Diligence
In my regular review of industry press releases, patents (and applications), peer-reviewed journals and other medtech sources, I am occasionally struck by an article or paper that I find compellingly succinct or clear or detailed — or all of the above. The clinical background and technology development of coronary drug-eluting stents are areas I have monitored and published on through different media (most recently through our industry report), so even a particularly clear article may not provide me with more than a confirmation of my understanding. However, I find a geeky need (or social networking compulsion) to pass along such articles to my audience. Such is the article (mobile version) in an August 2009 issue of the Journal of the American Academy of Physician Assistants. See the opening, pithy synopsis:
Coronary atherosclerotic disease remains the leading cause of mortality in the industrialized world. One American dies from coronary heart disease (CHD) every minute, with an estimated 1.2 million MIs occurring annually in the United States.1 With the epidemic of obesity in this country and Americans’ increasingly sedentary lifestyle, more patients are at risk of developing CHD than ever before. Additionally, more patients are developing abnormal lipid profiles at younger ages, including elevated LDL and decreased HDL cholesterol levels. Abnormal lipid profiles are a well-documented risk factor for the development of atherosclerosis. The coupling of abnormal lipid profiles with vascular injury promotes atherosclerosis, causing symptomatic CHD, including angina pectoris and MI. When symptoms can no longer be medically managed, more invasive options, including percutaneous intervention (PCI) and coronary artery bypass grafting (CABG), may be advised. This article reviews the factors leading to development of CHD and the evolution of PCI technology, discusses how to identify which patients are the best candidates for drugeluting stent (DES) implantation, and explains how to maintain patient safety after PCI.
See also the 2009 report from MedMarket Diligence on the global coronary stents market at link.
The August 24, 2009, issue of the "Journal of the American Academy of Physician Assistants" presents a concise, yet accurately detailed view of the full context — coronary heart disease, clinical practice, demographics, complications, etc. — for the use of drug-eluting coronary stents. Having focused on drug-eluting stents (DES) from the product market analysis, I was impressed with the succinct detail of this overview.
"Coronary atherosclerotic disease remains the leading cause of mortality in the industrialized world. One American dies from coronary heart disease (CHD) every minute, with an estimated 1.2 million MIs occurring annually in the United States." continued
The May 2009 MedMarket Diligence Report #C245 details the global market for drug-eluting, bare metal, and other coronary stents.
Different material types, constructions and designs comprise devices for anti-restenosis following interventional cardiology (percutaneous coronary intervention). These include drug-eluting stents (such as those of J&J/Cordis, Boston Scientific, Abbott and Medtronic), the stainless steel or CoCr bare metal stents of J&J/Cordis, Abbott, Sahajanand Medical Technologies, and others. Below is a selection of the anti-restenosis device types and associated descriptions.