Cardiovascular procedure volume growth (interventional and surgical)

Cardiovascular surgical and interventional procedures are performed to treat conditions causing inadequate blood flow and supply of oxygen and nutrients to organs and tissues of the body. These conditions include the obstruction or deformation of arterial and venous pathways, distortion in the electrical conducting and pacing activity of the heart, and impaired pumping function of the heart muscle, or some combination of circulatory, cardiac rhythm, and myocardial disorders. Specifically, these procedures are:

  • 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

For 2016 to 2022, the total worldwide volume of these cardiovascular procedures is forecast to expand on average by 3.7% per year 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).

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).

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

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


Global Cardiovascular Procedures report #C500 details the current and projected surgical and interventional therapeutic procedures commonly used in the management of acute and chronic conditions affecting myocardium and vascular system.

New Global Cardiovascular Procedures Report Reveals Medtech Outlook

MedMarket Diligence has published, “Global Dynamics of Surgical and Interventional Cardiovascular Procedures, 2015-2022.”

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

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

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

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

Excerpts available on request.

Coronary artery disease treatment map

As an exercise, I found it worthwhile to map out the various options available or under development for the treatment of coronary artery disease.

We assess the emphasis of current, near-term and future possible options for treatment in the color-coded scheme:

Bold, black:  Current, dominant treatment options

Green:  Near term options with potential to gain significant caseload

Red:  Long-term option with potential to dominate all caseload

 

 

Source: MedMarket Diligence, LLC; Report #C245

DES and other coronary artery disease treatment tech trends

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See the December 2015 report, “Global Market Opportunities in Peripheral Arterial and Venous Stents, Forecast 2020”. A $500 advance discount is available until publication.
details
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A steady rate of technology development in coronary stents, producing an equally steady stream of new stent market introductions, is focused on expanding aggregate stent caseload (through penetration of what would otherwise be coronary artery bypass caseload) or shifting the balance even further toward concentration of stents sales to the drug-eluting stent (DES) variety.  While unit volumes are on the rise, pricing pressures have dampened this overall market growth and will continue to put a squeeze on stent margins.  This trend has been in force for the past two years (since the late stage thrombosis scare subsided), but going forward there will be more significant forces and developments impacting the stent market, principally the emergence of novel stent technologies like bioabsorbable stents, the emergence of drug-eluting balloons and the development of other anti-restenosis or anti-atherosclerosis options.  These dynamics are the focus of the MedMarket Diligence report #C245, the post below being a brief excerpt from that report.

The evolution of the coronary stent market has been driven by manufacturers focused on expanding the use of coronary stents into new caseload as well as penetrating the market shares of competitors.

Clinicians, for their turn as gatekeepers in this effort, are guided in the adoption of stent technologies by the availability of clinical evidence supporting expansion of stent use to patients whose coronary heart disease might otherwise be addressed by coronary artery bypass graft (CABG) surgery, with their selection of the specific stent used determined (to the extent that price is not an overriding attribute) by how well each stent’s clinical data stands up under scrutiny of possible clinical complications.

Manufacturers then take a hard view of both cost and complication rates.  Below are shown the potential complications ensuing from stent implantation and which have therefore become a focus of stent technology development:

Potential Complications Related to Implantation of Cardiovascular Stents

stent-complications

Source: MedMarket Diligence report #C245, “Worldwide Market for Drug-Eluting, Bare Metal and Other Coronary Stents, 2008-2017.”

Some novel stent technologies are under development by: AdvanSource Biomaterials, Allvivo Vascular, Inc., Blue Medical Devices, CeloNova BioSciences, Hexacath, InspireMD, ITGI Medical Ltd., Miami Cardiovascular Innovations (MCVI), MoBeta, Inc., Nexeon MedSystems, Inc., OrbusNeich, Palmaz Scientific, and Prescient Medical.  Other technology developments in coronary artery disease treatments, beyond stent technologies, are also addressed in report #C245.


Download report #C245, “Worldwide Coronary Stent Market, 2008-2017,” PDF — $2,850.00
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Coronary artery disease: stents, bypass — and plenty of other options

Because of the invasive nature of cardiac surgery, medical therapy will always be the preferred treatment protocol favored by many clinicians. To that end, device and pharmaceutical manufacturers continue to explore methods of treating atherosclerosis that will render surgery unnecessary.

For instance, researchers at the Medical University of Graz in Austria announced in February 2009 (Journal of Lipid Research, 50:312-326) progress related to their study of a synthetic atherosclerosis drug that can reduce the build-up of plaque without producing the side effect of fatty liver disease, which can lead to other disorders such as diabetes. However, in some instances, more aggressive therapy is required and for those patients, there is a host of therapy choices available — all of which can prove to be competitive with stenting technology.

The range and diversity of alternatives for treatment of acute coronary artery disease are striking:

  • angioplasty with or without stenting
  • atherectomy
  • coronary artery bypass grafting
    • open CABG
    • off-pump CABG
    • MIDCAB (minimally invasive direct coronary artery bypass)
    • RACAB (robotic assisted coronary artery bypass)
    • other CABG
  • genetic therapies
  • transmyocardial laser revascularization
  • HDL therapy
  • drug-eluting balloons
  • nanoparticles and other agents

While the caseload distributed across these alternatives is concentrated in angioplasty (with stenting) and coronary artery bypass grafting, the acute nature of coronary artery disease, the size of the caseload and the continued pressure on clinicians to reduce the associated trauma of treatment give incentive to developers seeking to produce better outcomes.

The MedMarket Diligence report #C245 is described at http://mediligence.com/rpt/rpt-c245.htm and details the worldwide market for the use of alternative stent devices in the treatment of coronary artery disease. The report assesses the treatment of coronary artery disease by alternative treatment methodologies (percutaneous intervention with or without stenting, coronary artery bypass grafting alternatives and other medical/surgical treatment options), with estimated current/forecast caseload across treatment types.

The report is described at this link. The report may be ordered for immediate download online.


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Coronary stent market opportunity

Stenting is not ideal for all patients with coronary heart disease, such as those with left main or three (or more) vessel disease. However, the vast majority of cardiovascular disease patients can benefit from the benefits of PCI, not the least of which include a shorter recovery period and less trauma to the patient.

The global market for coronary stents is over $7 billion and growing steadily. With the average age of citizens in developed countries increasing, there is an increased need to provide medical care to the average citizen. As such, an aging population translates into increasing numbers of people needing medical therapy and increasing numbers of people who need more aggressive medical therapy due to the aging process. As the population of developed countries ages, the number of percutaneous coronary interventions (PCIs) required increases as well. Currently, the incidence of PCI procedures (sometimes referred to as percutaneous transluminal coronary intervention or PTCA) is increasing at a rate of 3%–5% worldwide. Today, the vast majority of PCIs involve the implantation of one or more coronary stents.

Until the advent of coronary stents, patients with cardiovascular blockages had little choice but to either keep a close eye on their disease (“watchful waiting” with or without accompanying pharmaceutical therapy) or undergo coronary artery bypass grafting (CABG). When angioplasty was developed by Andreas Gruentzig in 1977, patients were presented with the option to undergo angioplasty in an effort to open blocked coronary arteries. While short-term benefits were usually seen with balloon angioplasty, longer-term outcomes showed many arteries re-closing and requiring repeated intervention; up to 50% of angioplasty patients were found to require further angioplasty within six months. In an effort to reduce the frequency of patients requiring reintervention, scientists and clinicians developed stents that could be left behind to hold the artery open once the PTCA balloon was withdrawn.
Unfortunately, clinicians found that bare metal stents (BMS) could cause an immunological response that would try to “protect” the body from the foreign material (i.e., the stent). This, in turn, would lead to further narrowing near to or inside the stent, as seen in roughly 25% of patients receiving BMS devices. To combat this, drug-eluting stents (DES) were developed. 

Drug-eluting stents were developed to release a drug (e.g., sirolimus or paclitaxel) intended to reduce the incidence of restenosis. From there, even more innovative products have been developed, such as bioactive stents or stents designed to attract a patient’s own endothelial cells to coat the stent (as in devices by OrbusNeich, Hexacath, and Miami Cardiovascular Innovations).

Other device developers have sought to create stents that will fully degrade and disappear over a period of weeks or months—of a score of companies in this area, Abbott Vascular, Biotronik and REVA Medical appear closest to market. Yet others seek to abandon the use of stents altogether, opting instead to pursue an angioplasty balloon that will leave the anti-inflammatory drugs behind without the accompanying stent, as with CE Mark approved devices by EuroCor (the DIOR catheter) and B. Braun Melsungen (the SeQuent Please catheter).

Because the ultimate therapy has not yet been found, many opportunities still exist for effective therapies to combat atherosclerosis. So far, coronary stents hold the most promise for effectively treating an aging population with an increasing incidence of coronary artery disease.


See also, "Worldwide Coronary Stent Market, 2008-2017" at link.

Palmaz says the stent future is in bare metal

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.

See full story on theheart.org at link.

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.

Posted via email from medmarket's posterous


Global stent market, Report #C245.

Krucoff: Second-Generation Drug-Eluting Stents Better at Anti-Restenosis

The improvements in stent flexibility and biocompatibility have lead to the conclusion by Dr. Mitchell Krucoff that second-generation drug eluting-stents, such as Abbott's Xience stent, result in an improved ability to prevent restenosis following angioplasty and stent implantation. See an excerpt from India's pharmabiz.com (which also highlights the market potential for coronary stents in India):

Newer drug eluting stents (DES) are proving to be significantly more effective and safer compared to the 'first-generation' drug eluting stents. DES is developed to reduce incidents of re-blockage or restenosis which occur with bare metal stents and almost all trials showed a marked reduction in restenosis rates. The ideal drug eluting stent is one which demonstrates high efficacy while maintaining excellent safety profile. The latest stents made of polymer and steel are known for higher biocompatibility. These are thinner in appearance and more flexible. The lower doses of the drug are much preferred as a long treatment option for complex and difficult cases. Another big advantage is the negative side effects. The drug eluting stents reduced the need for a second intervention procedure by about 40 to 50 per cent compared to bare metal stents especially in complex cases where patients reported long blockages in diabetics and those having small blood vessels, according to Dr Mitchell Krucoff, interventional cardiology scientist and advisor to US FDA on medical devices. See more at link

See Worldwide Coronary Stent Market, 2008-2017.

Growth of coronary stent market in Japan, China

(The global market for coronary stents worldwide is assessed in the MedMarket Diligence report #C245, "Worldwide Market for Drug-Eluting, Bare Metal and Other Coronary Stents, 2008-2017.")

japan-china-stentsThe market for coronary stents in Asia and the Pacific region contains both China (early technology adopters) and Japan (with a longer regulatory approval cycle), which generated a combined majority of stent sales from the region. The Asia/Pacific market for coronary stents is forecasted to grow 6.7% annually over the period from 2008 to 2017.

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In terms of stent type, the Asia/Pacific market is dominated by drug-eluting stents, which represent roughly 80% of the market—a much larger portion of the stent market than seen in other regions. This is due to the fact that in China, nearly 100% of coronary stents used are drug-eluting. The remaining 20% of the market represented by bare metal stents are largely in those areas outside China.

The introduction of bioabsorbable stents will increase the total market for coronary stents and reduce the dominance of "non-bioabsorbable" drug-eluting stents in the market, although (as we have implied) a share of bioabsorbable stents will be of the drug-coated variety.


Data sourced from MedMarket Diligence Report #C245 (published 2Q 2009).

Coronary stents: Big differences in adoption globally

Market drivers that vary geographically account for some big differences in the distribution of the coronary stent market across the currently available stent types, and these differences will continue when bioabsorbable stents (and others) are introduced to the market over the next few years.

The local market forces dictating these differences include:

  • Regulatory timelines in one market that can delay new product introductions by a year or more compared to another market
  • Regulatory control that either limits or facilitates introduction of local market ("me too") stent developers.
  • Differences in clinical adoption of advanced technologies driven by local practice patterns
  • Price sensitivities that can vary considerably from one geography to the next, with the potential to severely restrict the adoption of advanced technologies and/or force price reductions

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The coronary stent market illustrated distinct differences in market segmentation on the basis of geography, challenging assumptions of the expected market shares of current and potential stent manufacturers competing in each local market.  One of the most distinct differences is the relative adoption of drug-eluting stents in China (captured in Asia/Pacific, below) versus either the U.S. or Europe. 

Source: MedMarket Diligence, LLC.  Report #C245, "Worldwide Coronary Stent Market, 2008-2017."