Endovascular Technologies Drive AAA and TAA Stent-Graft Market

Stent-Grafts for AAA will represent a $1 billion market in less than five years.

Endovascular aortic repair (EVAR) is one of the most significant technological advances in vascular surgery over the last decade and continues to show promise as a less-invasive alternative to conventional surgery in treating patients with abdominal aortic aneurysms (AAAs) or thoracic aortic aneurysms (TAAs). As manufacturers make ongoing refinements to endovascular devices for aneurysm therapy, the estimated 2.7 million aortic aneurysm patients in the United States have more treatment options available than ever before. Although aneurysms are far less common than heart attacks, they are also far more fatal. According to the National Center for Health Statistics, roughly 15,000 patients die annually from ruptured aortic aneurysm, and this number may be low because the condition can be overlooked easily in a standard autopsy. Ruptured abdominal aneurysm is currently the 13th leading cause of death in the United States. In fact, as many as 2 of 3 patients with an AAA rupture die prior to reaching the hospital. Even with open surgery, there is an average 48% mortality rate associated with patients having a ruptured AAA. AAAs typically enlarge slowly and without symptoms, making them difficult to detect. However, detecting AAAs early and repairing them can decrease the death rate by one-sixth. TAAs are also under-diagnosed because most patients are asymptomatic. The incidence of TAA in the United States ranges from 15,000 to 30,000.

Rapid Market Growth Expected
The endovascular stent-graft market will continue to expand rapidly for a number of reasons. One primary driver comprises increasing numbers of patients who will select this less-invasive procedure over the traditional open surgery with its longer recovery periods and higher rates of complications. In addition, the aging population will continue to expand, putting more people at risk for aneurysm. It is estimated that 5%–7% of those over age 65 has an AAA. Finally, implementation of screening programs will detect a greater number of cases of aortic aneurysm, thus leading to an increase in the number of endovascular stent-graft procedures. The chart on page 1, “Worldwide Market for AAA Stent-Grafts,” illustrates this growth. The first endovascular aortic grafts were available for use in the United States in 1999. Now there are four AAA endografts that are FDA-approved and available commercially in the United States for EVAR: Cook’s Zenith AAA, Endologix’ Powerlink, Medtronic’s AneuRx, and Gore’s Excluder. Gore is the only company with a TAA endograft (the Gore TAG) on the U.S. chart, “Developers of Endovascular Grafts for Abdominal and Thoracic Aneurysm Repair”). TAA endografts show great potential, not only for the treatment of TAA but also for other anomalies of the thoracic aorta, such as acute and chronic dissections, penetrating ulcers and traumatic injuries. U.S. research institutions are serving as clinical trial sites for next-generation aortic endografts made of synthetic fabrics. Boston Scientific’s TriVascular Enovus AAA and the Terumo/Vascutek Anaconda are examples of investigational endografts that incorporate new design features, taking into account varying patient morphology. market; other manufacturers’ devices are in development and/or are available outside the United States. TAA endografts show great potential, not only for the treatment of TAA but also for other anomalies of the thoracic aorta, such as acute and chronic dissections, penetrating ulcers and traumatic injuries. U.S. research institutions are serving as clinical trial sites for next-generation aortic endografts made of synthetic fabrics. Boston Scientific’s TriVascular Enovus AAA and the Terumo/Vascutek Anaconda are examples of investigational endografts that incorporate new design features, taking into account varying patient morphology.

Looking Ahead
The rate of EVAR should increase rapidly within the next decade with the advent of promising technologies such as lower-profile devices that allow percutaneous delivery and endostapling devices that offer increased durability as well as the ability to treat short, angulated necks. Imaging modalities used with EVAR also will continue to improve, providing greater accuracy for screening, as well as procedural and post-procedural surveillance needs.

Tags: medtech, aortic-aneurysm, stent, stent-graft

Meanwhile, American Medical Systems Corners a Market

Company Steadily Secures the Urogenital Treatment Market
The acquisition of Laserscope by American Medical Systems Holdings this month for $715 million adds a certain punctuation to AMSH's steadily growing presence in the field of urogenital medicine or, as the company refers to it, "pelvic health." Lest there be any doubt, AMSH has been on a Tyco-like drive of acquisitions that have garnered it a clear lock on urogenital markets. In May 2006, the company acquired Solarant Medical, a maker of minimally invasive therapies for stress urinary incontinence. In April 2006, AMSH acquired BioControl Medical for its implantable electrical stimulation technology, which the company will use to develop its own incontinence treatment technology. In 2004, the company acquired TherMatrx, the developer of an office-based thermal treatment for BPH, In 2003, the company acquired CryoGen, the developer of cold technology for treatment of menorrhagia, and the company also acquired erectile dysfunction technologies from Endocare in 2003...the list goes on.

While Boston Scientific and Medtronic fight tooth and nail in both the courts and the markets to gain turf in the cardiovascular device industry, we watch with interest as AMSH has steadily purchased its own plot of real estate in the urogenital arena, a field that while putatively overshadowed by cardiology, represents a hugely attractive area of upside potential, and growing less crowded all the time.

Tags: medtech, urogenital, urology, bph, prostate, incontinence

Megatrends in Medical Technology

(June 2006 MedMarket Outlook in MedMarkets)

Megatrends in Medical Technology
Aside from other trends in the medical product industry we've addressed previously in MedMarket Outlook, such as the dissolution of boundaries between device and pharmaceutical technologies, the increasing integration of information and information technologies with medtech, and the rise of "holistic research" (aka "systems biology") that recognizes the value of studying pathology with a multidisciplinary scientific approach, there are specific overarching trends and forces that are changing medical technology and the markets for them on a grand scale.

Stem Cell Research
The debate about stem cell research was no more likely to end as a result of President Bush's restriction on federal funding as it was that the established cell lines would be sufficient or appropriate for research (they weren't) or that the case would abate (as they have not) for the use of stem cells in the treatment of diabetes, Parkinson's, spinal cord injury or other disease and disorders. Here, we make no ethical case for or against embryonic or somatic stem cell research --- the debate is likely to become wholly moot in a matter of time --- we only comment on the inevitability of the science moving forward one way or another. In June, Harvard University's Harvard Stem Cell Institute confirmed that two projects focused on cloning to produce embryonic stem cells will move forward under private funding. The projects employ the same general type of research, somatic cell nuclear transfer, that is underway at the University of California at San Francisco and at the University of Connecticut's Center for Regenerative Biology. Aside from these approaches, a cursory review of the state of cell research in general and stem cell research in particular will reveal that researchers have both the innovation and the willingness to pursue cell therapeutics that lead to treatments heretofore not possible. It seems fairly certain that, looking back at progress in the development of the range of cell therapies, the Bush administration's federal funding restriction will be seen to have produced a momentary hitch rather than the obstacle it was originally portrayed as producing.

Nano- and Microscale Juggernaut Forces
There are as many different functions -- maybe even more -- being provided by technologies designed around nanoscale or microscale level as there are different types of these technologies. The sole criteria for technologies grouped into the nano and micro categories is size. Aside from their size, there is then little common among these technologies, which represent an incredible array of devices, molecules, materials and other products that achieve functions not possible on the macro scale, even if one only considers nano- and microscale medical applications. These range from products that are largely nanoscale materials (e.g., silver nanoparticles as antimicrobials in wound management) to those providing functions such as artificial retinas, cancer diagnostics, drug delivery and biosensors. As an industry, nanotechnology (more so than MEMS, which has found considerable realized success) has been plagued by a combination of inflated promise and underestimated technical hurdles, but while MEMS (microelectromechanical systems) has found bigger initial commercial success, nanotechnology has begun scoring commercial success that will ultimately result in markets that will eclipse MEMS products by orders of magnitude.

Open Surgery in Decline, or the Rise of the Minimally Invasive, Less Invasive, Interventional, Percutaneous and Other Alternatives to Surgery
Often stated, but never emphasized enough, is the compelling drive for treatments (that were all too recently delivered exclusively via surgery) to be associated with, or replaced by, ever-decreasing invasiveness. Device manufacturers have well established records for producing devices that not only minimize the trauma of surgery (e.g., laparoscopy) but also promise to make open surgery obsolete (e.g., percutaneous procedures like coronary anastomosis). Driving this trend is the persistent recognition that "collateral damage" in achieving clinical outcomes is unacceptable, whether from the perspective of the physician seeking to optimize results, the healthcare system seeking to minimize the costs of healthcare (or optimize revenue streams by being able to market the latest less-invasive techniques) or the patient seeking to minimize the impact of surgery on his/her busy lifestyle.

Disease State Centered Marketplaces
Certain technologies in certain clinical areas remain the predominant if not exclusive option for treatment in those areas. However, in 2006, any legitimate competitive analysis of a market considers a multitude of different technology types. Case in point: any treatment for coronary artery disease will of necessity consider the competitive threat of bare versus eluting stents, angioplasty, atherectomy (waning but not gone), products for identification/treatment of vulnerable plaque, traditional coronary artery bypass, MIDCAB, OPCAB and other bypass variants (e.g. robotics), percutaneous bypass, atherosclerosis-reversing drugs and others. Compelling arguments must be created through the intrinsic advantages of new technologies in order to secure sought-after shelf space in the cost-fixated healthcare system armamentarium.

Materials Science Creating/Upending Markets
Underlying a stunning number of new technologies, from biodegradable/resobable stents, cellular scaffolds and a wide arrange of other implant types are the advances in materials sciences that are leading to the ability to engineer implants that now go well beyond providing solely structural roles. Driving these advances are the needs to improve upon the function of implants as static, inert devices that do not fully reflect the in situ need upon implantation, fail to adapt to changing conditions or otherwise do not provide the functions that optimize the end results of the implants' use. Whether by impregnation with different substances or by the nature of the implant material employed, implants have improved considerably in being able to not induce an anti-inflammatory response, to provide anti-microbial function to the device, to minimize formation of blood clots and to avoid the effects like restenosis of vasculature following interventional procedures. With the need for implants frequently changing at some point after their implantation, more devices -- biodegradable/bioresorbable stents, matrices/scaffolds for tissue engineering and others -- are being developed that are either resorbed completely by the body or just enough to be expelled in whole or in part once their purposes have been served. Lastly, materials science and implant engineering in general have also been able to simply produce implants that are more easily deployed through tortuous twists in vessels or through narrow channels in endoscopic devices. Expectations are that more complex functions will be served by implants as a result of these trends and forces in development, from the increasing sophistication of drug delivery in various passive and active forms, to the ability of implants to respond via biofeedback to changing conditions in situ, and to providing increasingly sensor-like functions. Increasing demands are being made of the medical product marketplace -- cost, competitive technologies, financial performance of public companies, etc. -- but it seems clear that these demands are driving the proliferation of technologies that indeed satisfy them, sometimes with each advance creating ever greater demand in an endless progression. It also seems apparent that this "technology burst" is taking place simultaneously with the increasingly strident need for healthcare costs to get under control. The focus in the U.S. Congress on the need for Medicare reform, and reform in the U.S. healthcare system overall (up to an including the increasing drive toward universal healthcare), is gaining greater intensity and may well yield more than nominal changes to the system. The medical product industry is likely to both respond to these changes and facilitate solutions that we can scarcely imagine even now.

Tags: medtech, nanotech, mems, stem-cell

Categories on medtech companies tracked

Not a great picture, I know, but this is partly due to technology limitation (mobile phone pic sent to go@mobile.com). But this is a screenshot of the one of the database data entry forms used in our internal company database, which in turn is used to track medtech companies (and other entities (e.g., VCs, providers, etc.) active in medtech. The categories include technology type (biopharm, device, pharm, biotech), major clinical applications (cardio dx, cardio tx, surgery, orthopedics, cell therapy, tissue engineering, patient monitoring, minimally invasive therapies, etc., etc.). We also segment by manufacturer, distributer, healthcare provider, etc.

Tags: medtech, companies, healthcare expenditure

Wasted Medicine: A Mantra

A report in the June 7 issue of the Journal of the National Cancer Institute (see article in Medical News Today):

Screening for cancer can find tumors that might not otherwise have been diagnosed in a person's lifetime, a situation called overdiagnosis. Overdiagnosis wastes health care resources. Tests and treatment resulting from overdiagnosis can lead to substantial toxicity and even premature death in patients.

I find this interesting, unsurprising and largely irrelevant. First, I have to note that I was struck with the use of the term "overdiagnosis", which I would expect to be a term used to describe an exhausted physician. I'm certain the authors intended to mean something akin to "false positives".

It is unsurprising in that I expect clinical practice to occasionally result in instances where there appears to be a problem that, under further evaluation, turns out not to be a problem. The alternative is to miss the problems, resulting in pain and/or death.

It is largely irrelevant because, in lieu of technology or clinical practice that is perfectly accurate and precise by never missing pathology and never mistaking normal tissue from abnormal, we must err on the side of false positives -- excuse me, overdiagnosis. Do we want to minimize the wasted use of our precious healthcare dollars? Are these non-trivial differences between accurate and inaccurate diagnoses? Who can argue against these questions?

A marketing manager was questioned by a new boss about a promotion to get registrants to a conference, and the boss questioned why the brochures were sent out to so many people. The manager responded, "Tell me who will attend the conference, and I'll only send brochures to them."

How is cancer really any different?

Tags: medtech, cancer, healthcare expenditure

Guidant Warning Letter Never Sent Over Concern of "Undue Alarm"

The New York Times reported today that in January 2005 Guidant drafted a letter warning doctors about a short circuiting defect in its Contak Renewal and Contak Renewal 2 defibrillators, but never sent the letters to doctors over concerns the letter would cause "undue alarm" and result in procedures to remove potentially faulty devices, and that such procedures would be associated with higher risk than simply leaving the debrillators in place. The letter and other documents were unsealed by a Texas judge overseeing a product liability lawsuit.

Of course hindsight is 20/20. With what Guidant (now Boston Scientific) knows now, there is no question (at least in my mind) that failing to send the letter, and instead sending the "product update" letter, was ill-conceived. The subsequent recalls and class action lawsuits caused a reveral of fortune for Guidant, knocking billions off the price tag of its sale to Boston Scientific.

If there was indeed real concern about the risk of explantation being higher than the risk from faulty defibrillators, then that is precisely what should have been communicated. It is difficult to conceive that Guidant calculated the potential fallout from the letter and deemed it to be greater than the fallout of not disclosing the defibrillator defects. In this day and age, in which every misstep by manufacturers is magnified with crystal clarity, it is an absolute obligation to understand the impact of product liability.

Tags: medtech, defibrillator, Guidant, FDA