Tag Archives: CABG

Trends in coronary stent prices (hint: not all down)

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.

Source: MedMarket Diligence report #C245

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.

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

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 stents: Types, technologies and impact

The global market for stents in the treatment coronary artery disease, while dominated by drug-eluting stents, continues to also be comprised of a diversity of stent technologies.  The market is evolving steadily as manufacturers aggressively seek optimal anti-restenosis, characterized by the goal of low rates of repeat revascularization.

As with many medical technologies, prices, availability in different geographies and other factors also support the range of stent alternatives, leaving opportunity for stent types along the continuum of technology types and maintaining competitiveness in the stent market.  Moreover, anti-restenosis is a goal of angioplasty that may also include a new twist, drug-eluting balloons.

(One must also keep in mind that cardiovascular surgeons will not lightly give up caseload in coronary artery bypass graft, with minimally invasive approaches and long term outcomes of CABG still putting up a strong challenge to coronary stents.)

Below are shown the major stent alternatives in the coronary stent market, with examples.

Types of Coronary Stents and Selected Anti-Restenosis Devices


Source:  Report #C245, "Worldwide Market for Coronary Stents, 2009"  

Purchase for download:  Report #C245, "Worldwide Coronary Stents 2009, PDF" — $2,850.00
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Drug-Eluting Stents Dominate Coronary Market, For Now

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

See press release on the MedMarket Diligence report #C245.

Posted via web from medmarket’s posterous

Purchase for download:  Report C245, "Worldwide Coronary Stents 2009, PDF" — $2,850.00
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DES are to BMS as BMS were to PTCA alone

Translation:  Drug-eluting stents are to bare metal stents as bare metal stents were to percutaneous transluminal coronary angioplasty alone.

In the September 1 post on the meta-analysis by researchers at Tuft Medical Center, we noted the overall findings in general terms of the value of drug-eluting stents compared to bare metal stents.  It is worthwhile to provide the slightly more detailed conclusions of the authors:

"As a new technology, drug-eluting stents have now emerged as an important innovation in reducing coronary restenosis. To provide a precise estimate of their clinical benefit and to explore sources of statistical heterogeneity, we performed a meta-analysis of randomized controlled trials involving currently available drug-eluting stents using a DerSimonian and Laird random effects model. Our meta-analysis found no significant reduction in mortality or MI-free survival from the use of drug-eluting stents. However, drug-eluting stents clearly reduced the risk of restenosis by 23% and the risk for target lesion revascularization by 11% in the primary analysis. This is similar in magnitude to the benefit found for stents compared to balloon angioplasty. The need for revascularization after DES was 3.7% that is similar to the 3.8% observed after coronary artery bypass grafting and much lower than the 21% with bare-metal stents."

I have engaged in debate (I might actually call it "baiting") wtih those who have instead favored coronary artery bypass graft (CABG) surgery, which I view as a waning procedure compared to percutaneous methods (like angioplasty with stenting) that revascularize with minimal trauma to achieve clinically competitive outcomes.   I would argue that the most minimally invasive procedure is ultimately likely to resemble a percutaneous one anyway.  Indeed, if one were to project the future evolution of CABG, it would traverse a course from thoracotomy to endoscopy (thoracoscopy) to an intraluminal procedure (which garners negative feedback from surgeons; but, of course, when speaking with surgeons, I expect their answers to be geared toward the scalpel).

By comparison, drug-eluting stents are on a course toward an analogously less invasive option, which I envision as first, atherosclerosis-reducing drugs and, probably ultimately, gene therapy that preemptively addresses the incidence of atherosclerosis.  Right now, that is fantasy, but not by much.

See also the MedMarket Diligence report #C245 on the global market for coronary stents. 

Coronary stent technology and market development is highly competitive

The global coronary stent market faces continued growth, development and competition from a wide range of technology types and competitors. The market is detailed in a new report from MedMarket Diligence.


PRLog (Press Release)Aug 31, 2009 – Since the advent of coronary stents, followed by the emergence of drug eluting stents, the field of stents in the treatment of coronary artery disease has been characterized by aggressive development of new technologies, from minor changes in strut design and drug-coating processes to more radical thinking of the kind that lead from bare metal stents to drug-eluting stents.  The coronary stent market is currently in a phase in which the clinical and market success of drug-eluting stents introduced six years ago has stimulated innovation toward emergence of new drug-eluting stent types from many competitors.  While the less invasiveness of coronary stents (delivered percutaneously) and outcomes of drug-eluting stents that are nearly comparable to coronary bypass are enabling coronary stents to expand the absolute market of coronary stents by capturing caseload from CABG, the market once dominated by Johnson & Johnson’s Cordis division is now becoming progressively fragmented with new competitors.  The market is now facing new challenges with the pending emergence of bioabsorbable stents, drug-eluting balloons and other competitive alternatives to the established stent market.  

The global market for coronary stents, examining the products, technologies, companies and worldwide markets for bare metal, drug-eluting and other coronary stents, is the subject of MedMarket Diligence’s report #C245, "Worldwide Coronary Stents 2008-2017" (published May 2009).  See http://mediligence.com/rpt/rpt-c245.htm.

"The nature of coronary artery disease, as a major source of morbidity and mortality worldwide, and the support (including especially reimbursement) that treatments receive in the healthcare arena, is a major impetus for technology development," says Patrick Driscoll of MedMarket Diligence.  According to Driscoll, there are no fewer than 75 active companies developing and marketing coronary stents and competitive technologies, and the market is likely to become even more consolidated unless new, innovative anti-restenosis technologies are introduced that demonstrate profound clinical advantages over existing options.

The market is facing the emergence, in particular, of bioabsorbable stents, which have demonstrated their potential to provide the necessary anti-restenotic benefit following percutaneous intervention (e.g., angioplasty), then "simply" dissolve and be absorbed at six months or later.  Such a device has the potential to eliminate longer term biocompatibility and otherwise inflammatory risk associated with permanently implanted stents.  Bioabsorbable stents, too, may be bare or, more likely, contain drug coatings.

The MedMarket Diligence report details the worldwide market for the use of alternative stent devices (cardiac stents or heart stents) 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 details currently approved coronary stents, providing data on current and forecast impact on the market.  The report also details the current state of product development in bare stents, drug-coated or drug-eluting stents and bioabsorbable stents in coronary applications and details the products under development, the anticipated timeline and impact of their market introduction.  The report assesses the current and ten-year forecast global market for coronary stents, with segmentation by U.S., Europe, Asia/Pacific and Rest of World.  The report provides competitor market shares by these geographic regions.  The leading and key emerging coronary stent manufacturers are profiled with current product offerings, development status and market strengths/advantages.

The report is described at http://mediligence.com/rpt/rpt-c245.htm.  The report may be ordered for immediate download at http://mediligence.com/store/page30.html.


Open Coronary Artery Bypass Graft (CABG): A Fading Standard for Treatment of Coronary Artery Disease?

Treatment of acute coronary artery disease was first accomplished surgically via the coronary artery bypass graft procedure some 45 years ago, then by angioplasty 32 years ago and finally by stenting 23 years ago.  Despite the evolution of treatment alternatives (which continue to evolve), CABG has represented a benchmark, if not gold standard, against which alternative treatments are judged.  Below is an excerpt from the MedMarket Diligence report, "Worldwide Market for Drug-Eluting, Bare Metal and Other Coronary Stents, 2008-2017" (Report #C245).

Coronary artery bypass graft (CABG) surgery is one of the therapies that can be used to treat patients whose coronary arteries are excessively blocked. CABG patients are typically selected for the procedure depending on the extent of their disease and the severity of symptoms while taking into account the patient’s age and the presence of other medical conditions that might make a CABG procedure too risky.

The goal of CABG surgery is to relieve symptoms of coronary artery disease, including angina, to allow the patient to return to a normal lifestyle and to lower his or her risk of suffering a heart attack or other cardiac incident.

Roughly 1,313,000 inpatient PCI procedures were performed in 2006 while 448,000 inpatient bypass procedures were performed, according to the American Heart Association. More than 800,000 CABG procedures were performed worldwide annually.

An open CABG procedure uses a blood vessel graft to restore normal blood flow to the heart. Most often, three or four arteries are bypassed in a single surgery. Typically, the grafts are harvested from the patient’s own arteries and veins from the chest (thoracic), leg (saphenous) or arm (radial). Internal mammary arteries (IMAs, also known as internal thoracic arteries [ITAs]) are the most common types of grafts used because of the excellent long-term success rates associated with use of these arteries. Often, ITAs can remain intact at their origin and thus maintain their own oxygen-rich blood supply. The other end is sewn to the coronary artery below the site of the blockage. Upwards of 90% of all CABG patients receive at least one internal artery graft. Other thoracic arteries used in CABG include the gastroepiploic and the inferior epigastric arteries.

To perform an open CABG procedure, the patient is placed on a cardiopulmonary bypass (CPB or heart-lung bypass) machine that temporarily takes over the function of the heart and lungs during surgery, thus maintaining the circulation of the blood and the oxygen content of the body. This “on-pump” surgery allows the surgeon to perform the bypass on a still heart.

Unfortunately, complications associated with CPB machines can be significant. These can include: postperfusion syndrome, hemolysis, capillary leak syndrome, clotting of blood in the circuit (particularly in the oxygenator), stroke, air embolism, device leakage (the patient will lose blood perfusion of tissues if a line is disconnected), kidney problems, and problems with mental clarity and memory.

Also, the costs incurred for procedures using a CPB machine are typically very significant. As such, several alternative procedures have been developed that allow coronary artery bypass to be achieved without the use of a CPB or heart-lung machine.

With a traditional, open CABG, patients typically remain in the intensive care unit for one to two days after the surgery, then are transferred to a standard nursing unit for another three to five days. Generally speaking, an average hospital stay for conventional CABG patients is 6–10 days. Full recovery usually occurs within two or three months.

Some results still point to the superiority of CABG over DES in some patient groups, such as those with multivessel disease. For instance, results published online April 6, 2009 (ahead of print in Circulation) showed that in nearly 4,000 patients with multivessel coronary artery disease, the longer-term rates of myocardial infarction, death, and TVR after stenting was significantly higher with DES. The rates in this study, led by Shengshou Hu, Md, PhD of Fuwai Hospital (Beijing, China), were higher than those found in the DES arms of Syntax. For this study, 1,834 patients had DES while 1,886 had CABG between April 1,2004 and December 21, 2005. After three years of follow-up, the DES patients showed unadjusted TVR rate to be 17.6% versus 4.2% in CABG patients. However, because the study was nonrandomized, many physicians are reluctant to put much stock in the findings. Also, the DES used in the study were not commercial stents from the United States but instead were developed by Chinese companies. Both paclitaxel and sirolimus stents were used in the study. 

Techniques for the performance of CABG continue to evolve, spanning off-pump ("beating heart") bypass, minimally invasive options (e.g., minimally invasive direct coronary artery bypass graft or MIDCAB), and even percutaneous CABG.

See MedMarket Diligence Report #C245.

Neurological complications of heart surgery

In a report published in MedLink Neurology, Dr. Jose Biller of Loyola University Chicago’s Stritch School of Medicine completed a comprehensive review and compilation of previously published clinical studies on the possible neurological complications of heart surgery (Neurological complications of heart surgery).  A range of difference potential complications have long been known to be attributable to heart surgery of various types, spanning cardiac bypass, angioplasty, valve repair, closure of PFO and others.

All surgery and interventional (e.g., cath lab) procedures have intrinsic morbidity risk generally well known to physicians.  Directly, the act of entering the vasculature, heart or other tissues can lead to the formation and release of blood clots and other immediate sequellae. These in turn can precipitate a range of complications like stroke, paraplegia, peripheral nerve dysfunction, vision problems, paralysis, hoarseness, movement disorders and disturbances in learning, memory, attention, concentration and mental agility

The report on neurological complications of heart surgery is noteworthy not for its identification of previously unknown complications, but for both its comprehensiveness in listing them and its confirmation that many of these risks are low and that cardiac surgeries generally "are highly beneficial and life saving".

"Worldwide Market for Drug-Eluting, Bare Metal and Other Coronary Stents, 2008-2017."  Report #C245.

Use of drug-eluting stents for patients with coronary heart disease

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.