Clinical and Industry News for February 2007

Latest IMV Market Report Shows Continued Investment in Cath Lab Technology According to IMV’s recent census of cath labs in the U.S., an estimated 4.21 million patient cases were performed at 1,970 cardiac cath lab sites in 2006. This represents a 9% increase from 3.85 million in 2002, for an average annualized rate of 2% per year. Of these cath lab cases, 89% (3.74 million) are cardiac-related and 11% are non-cardiac applications (including carotid, iliac, femoral, run-off, renal and extremity studies). While the number of cases has slowed to a 2% annual rate, budgets for capital equipment and catheter devices have increased at a faster pace, with new technology advancing cath lab capabilities, observed Lorna Young, Senior Director, Market Research. For instance, from 2003 to 2006, the average device budget per cath lab increased 18% per year to $1.8 million, as more sophisticated devices such as drug-eluting stents are adopted. Also, the proportion of sites with capital budgets of over $1.5 million has increased from 14% in 2000 to 30% in 2006, as hospitals invest in new technology such as flat panel digital detectors. IMV's 2006 Cardiac Cath Lab Market Summary Report describes trends in patient cases, cath lab imaging systems, diagnostic review stations, electrophysiology, intravascular ultrasound, hemodynamic systems, device utilization, contrast media utilization, power injectors for cath contrast, and site operations characteristics. Highlights include: 42% of the cath lab sites had one room, 27% had two rooms, and 31% had three or more rooms. 97% of the cath labs have and use electronic archiving only, while 1% use cine film only, with the remaining 2% using both. 88% of the cath lab sites have diagnostic quality digital review stations located outside of their rooms. The typical cath lab is utilized by an average of 10.8 cardiologists and 3.6 cardiology groups. The data source for this report is interviews conducted in 2006 for IMV’s 2006/07 Cardiac Catheterization Lab Census Database, which provides comprehensive profiles of cath labs in the United States. The database can be licensed by qualified subscribers and includes contact and site-specific information. IMV also performs customized analysis of the statistics to address client-specific analytical requirements. For more information about IMV’s Cath Lab Census Database and Market Summary Report, visit the corporate website at www.imvinfo.com or call 847-297-1404 to speak with a representative. Abiomed Announces FDA 510(k) Clearance For New Intraaortic Balloon and Development of Integrated Console, the iPULSE, for the Balloon, BVS 5000 and AB5000 Abiomed, Inc. announced U.S. Food and Drug Administration (FDA) clearance of its new intra-aortic balloon (IAB). The clearance by the FDA culminates more than two years of internal research and development. This new balloon was subject to extensive reliability testing and successfully demonstrated a life of over eight million cycles, which equates to more than 90 days of continuous operation. In addition to the IAB, Abiomed has developed a combination console platform, the iPulse, currently under regulatory review and pending approval, to support the new IAB. The new iPulse console will also support Abiomed’s BVS and AB5000 Circulatory Support Systems, as well as new product introductions by Abiomed in the future. The iPulse is also designed to be compatible with other OEM’s balloons as well. The new iPulse Console will now support procedures with associated Medicare reimbursement that extends across four diagnostic related groups (DRGs 110, 111, 525, 103) ranging from $15,000 to $180,000 per patient stay. The return on capital investment for the iPulse console can be achieved in less than six months. Abiomed expects to begin shipping its integrated iPulse console outside the U.S. during fiscal fourth quarter ending March 31, 2007. Following FDA approval of the pre-market application (PMA) supplement to the existing console, Abiomed’s initial introduction of the new iPulse is expected in the summer of 2007 to leading heart hospitals. Abiomed’s portfolio of products now include three platforms (Impella, iPulse, and AbioCor) and consists globally of seven disposable devices that span the cath lab to the intensive care unit to the surgery suite. Boston Scientific Announces First Use of Promus Everolimus-Eluting Stent System Boston Scientific Corporation announced the international launch and first implantation of the Promus Everolimus-Eluting Stent. Promus is a private-labeled Xience V Everolimus Eluting Coronary Stent System manufactured by Abbott and distributed by Boston Scientific. The Promus Stent received CE Mark approval in October 2006 which allows Boston Scientific to distribute the stent in select countries of the European Economic Area. It will also be available in selected countries in Asia, Latin America and Eastern Europe. A U.S. launch is planned for 2008. Dr. Willibald Maier performed the procedure on December 21, 2006 at University Hospital in Zürich, Switzerland, marking the first implantation of the Promus Stent. Positive results for the Xience V Stent were reported from the SPIRIT II clinical trial at the World Congress of Cardiology in Barcelona, Spain, demonstrating that the Xience V Stent met its primary endpoint of non-inferiority to the Taxus Stent as measured by late loss at six months. Boston Scientific's Taxus Stent System has a record of proven outcomes, including three million Taxus Stents implanted in patients worldwide and clinical follow-up on more than 4,000 patients out to four years. Promus and Taxus are trademarks of Boston Scientific Corporation or its affiliates. Xience is a trademark of Abbott. The SPIRIT Clinical Program is sponsored by Abbott. The Promus Stent is not approved for sale in the U.S. New Cardiovascular Disease Statistics Signal Need For 21st Century Management Strategies The cardiovascular patient population could exceed 100,000,000 by 2010. Statistics published by the American Heart Association, in Heart Disease and Stroke Statistics -2007 Update, indicate a significant increase in cardiovascular disease in the United States. A five-year analysis of statistical data by John Goodman, president of John Goodman and Associates, Inc., Las Vegas, NV, reveals a 22% increase in cardiovascular disease in the U.S., despite advances in treatment. If this trend continues, says Goodman, the cardiovascular patient population could exceed 100,000,000 by 2010. As the population ages and increases in size, the demand for cardiovascular physicians and hospital beds will increase. However, we are faced with decreasing numbers of cardiovascular physicians as well as a shortage of hospital beds. Goodman surmises that addressing this looming crisis will require creativity on the part of physicians and hospital administrators in order to manage what could be a health care emergency on the horizon. Traditional approaches haven’t worked in the past five years, Goodman says, so we have no reason to believe they will work in the near future. The American Heart Association statistics indicate that in 2004, the year on which the 2007 statistics are based, 79,400,000 people in the U.S. suffered from some form of cardiovascular disease. More women than men are victims of this incurable disease. Clearly, it is imperative that cardiovascular disease and its treatment move to the forefront of our national public health priorities and that those in the business of treating patients engage in complex and in-depth strategic planning to meet the needs of the millions of Americans afflicted, concludes Goodman. I hate to think of what the future holds if we don’t take action now. John Goodman & Associates, Inc. (JG&A) provides the full spectrum of consulting services for developing cardiac and vascular programs for hospitals, health care systems, academic centers, and physician groups. More information is available at www.jga-net.com AngioScore Receives Premarket Approval (PMA) for AngioSculpt® Scoring Balloon Catheter AngioScore, Inc, a developer of angioplasty catheters for use in the treatment of cardiovascular disease, announced today that its flagship product, the AngioSculpt® Scoring Balloon Catheter, has received Premarket Approval (PMA) from the U.S. Food and Drug Administration (FDA) for use in the treatment of hemodynamically significant coronary artery stenosis, including in-stent restenosis and complex type C lesions, for the purpose of improving myocardial perfusion. PMA approval allows AngioScore to begin marketing the AngioSculpt in the U.S. for the treatment (as indicated) of coronary artery disease (CAD). More than one million coronary angioplasty procedures are performed in the U.S. each year, with an additional 1.5 million procedures performed worldwide. In 2005, AngioScore obtained FDA 510(k) clearance to market the AngioSculpt in the U.S. for balloon dilatation of lesions in infra-popliteal arteries, one of the key segments of the rapidly growing peripheral artery disease (PAD) market. In addition, the company has also been granted the CE Mark for the AngioSculpt allowing the product to be sold in Europe and the Middle East. A semi-compliant angioplasty balloon is surrounded by a unique scoring element which works in tandem with the balloon to deliver a scoring effect to the target lesion upon balloon inflation. As the balloon inflates, the radial forces are concentrated along the surfaces of the nitinol scoring element. Barotrauma is reduced, resulting in lower dissection rates. Device slippage, which is commonly seen with traditional balloon catheters and may result in geographic miss, is eliminated with the AngioSculpt. The U.S. multi-center clinical trial was a prospective study evaluating the safety and effectiveness of the AngioSculpt in 200 patients with single or multiple vessel coronary artery disease, in both de novo lesions and in-stent restenosis lesions. The study’s principal investigator was Martin B. Leon, MD, Professor of Medicine at Columbia University and Chairman of the Cardiovascular Research Foundation (CRF). Gary Gershony, MD, AngioScore’s Chief Medical Officer, added: More than 75% of the lesions treated in the U.S. clinical trial were classified as type B2 or C, which are the most difficult and complex lesions facing physicians who perform angioplasty procedures. Yet even in this very challenging clinical trial, the AngioSculpt achieved a procedural success rate of 98.5% and a cumulative freedom from MACE (major adverse cardiac events) of 97.5% at follow-up, highlighting the excellent safety profile of this product. Terumo Interventional Systems Launches Pinnacle® R/O II HiFlo for Superficial Access Terumo Interventional Systems, a strategic business unit of medical device manufacturer Terumo Medical Corporation, has introduced an addition to its line of Pinnacle sheaths; the Pinnacle R/O II HiFlo Introducer Sheath. The new 4 cm, stiff introducer sheath features the Pinnacle’s recognized smooth transition which facilitates access to difficult superficial sites that may also be close to the location of a lesion. In addition, a larger diameter side flow tube allows a higher flow rate of fluids. With the addition of the Pinnacle R/O II HiFlo, the Pinnacle line now includes a product specifically designed for the special needs of superficial access procedures, said John Rooney, Vice President Marketing, Terumo Interventional Systems. The Pinnacle R/O II HiFlo also features a radiopaque marker band 5 mm from the tip for enhanced visibility, a laminar flow sheath housing with a 45° side tube take-off to improve flow dynamics, and a detachable 3-way stopcock. For more information, customers can contact Terumo Interventional Systems by calling its Inside Sales Customer Care Team at 800-862-4143 or by visiting https://www.terumomedical.com/interventional. Study Favors Taxus® Stent Over Cypher® Stent and Bare-Metal Stents in Diabetic Patients Lower rates of re-intervention and major adverse events reported for the Taxus Stent in study of diabetic patients Boston Scientific Corporation welcomed the results of an independent study demonstrating that Boston Scientific's Taxus® paclitaxel-eluting stent (PES) exhibited a lower re-intervention rate and equal or lower instances of death or heart attack than the Cypher® sirolimus-eluting stent (SES) and bare- metal stents (BMS). The results of the study were published in the January 1 edition of the European Heart Journal. The study, conducted at the Thoraxcenter, Erasmus University Medical Center in Rotterdam, The Netherlands, compared two-year clinical outcomes for 708 consecutive diabetic patients treated from April 2002 to April 2004 with either a Taxus Stent (n=250) or Cypher Stent (n=206) as part of the RESEARCH and T-SEARCH real-world registries. A group of 252 consecutive diabetic patients treated with a BMS prior to April 2002 was retrospectively selected as a control group. Eligible patients were undergoing pharmacological treatment with either insulin or hypoglycaemic agents at the time of the index procedure. The results showed favorable rates of re-intervention for the Taxus Stent compared to the Cypher Stent and BMS. Target lesion revascularization (TLR) occurred in a significantly lower percentage of Taxus Stent patients (5.3 percent) when compared with Cypher Stent (13.2 percent) and BMS (15.6 percent) patients (p=0.0037 PES vs. SES; p=0.0004 PES vs. BMS). Target vessel revascularization (TVR), another measure of re-intervention, showed similar positive trends for the TAXUS Stent, which reported a TVR rate of 9.7 percent compared to 15.3 percent for the Cypher Stent (p=0.06) and 19.5 percent for BMS (p=0.0034). The study's primary endpoint of major adverse cardiac events (MACE) was also lower for the Taxus Stent arm at 21.2 percent compared to 28.9 percent for the Cypher Stent arm (p=0.057 PES vs. SES) and 29.7 percent for the BMS arm (p=0.04 PES vs. BMS). Both MACE and TVR data demonstrated strong trends in favor of the Taxus Stent over the Cypher Stent while showing significant benefits for the Taxus Stent compared to BMS. Additionally, rates of MACE and TVR for the Cypher Stent and BMS were comparable (p=0.97 and p=0.35 respectively). Two-year cumulative incidence of mortality was comparable among the three stent groups, with rates of 11.5 percent for the Taxus Stent, 13.3 percent for the Cypher Stent and 9.8 percent for BMS. Myocardial infarction (MI or heart attack) was 5.1 percent in the Cypher Stent group compared to 3.4 percent in the Taxus Stent group. MI was significantly more frequent in the BMS group (7.7 percent) compared to the Taxus Stent group (p=0.048 PES vs. BMS). The stent thrombosis rate for the Taxus Stent was lower at two years than that of the Cypher Stent (2.4 percent versus 4.4 percent), however, the difference was not statistically significant (p=0.29). Stent thrombosis for BMS at two years was 0.8 percent, which was a statistically significant difference from the Cypher Stent (p=0.015) but not from the Taxus Stent (p=0.18). Resistin, Obesity and Surviving a Heart Attack Medical researchers at the Otago University’s Christchurch School of Medicine and Health Sciences in New Zealand have uncovered information which links a protein secreted by body fat with reduced heart function following a heart attack. The little-known protein, resistin, is secreted from fatty tissue around the body. The researchers have found that resistin appears to have a negative impact on the heart’s ability to recover after a cardiac event. Researcher Sarah Rothwell, MD, from the Cardioendocrine Research Group, says that fatty tissue may play a much more negative role in body chemistry than first thought. We’re now finding that all kinds of bad proteins and hormones can come from fatty tissue in obese people. This isn’t just fat which sits in the body and does nothing. It appears to be having active negative effects on the body, and resistin is part of this process. Dr. Rothwell’s research, published in the October 2006 issue of Biochemical and Biophysical Research Communications, demonstrates for the first time that when resistin levels are high in the blood, and the heart undergoes a major cardiac event such as a heart attack, it takes much longer to recover and doesn’t contract nearly so well to enable blood to be pumped around the body. Our study shows the heart only recovers 68% of its previous ability to contract when resistin levels are high. Normally it would recover to about 90%, so this reduction in contraction has major implications for survivability following a cardiac event, she explains. Dr. Rothwell says another interesting finding is that resistin seems to be linked with the release of a potentially harmful protein, TNF Alpha, which has already been associated with inflammation and increased heart cell death. These findings add more important information to the cascading effects of heart proteins and hormones which have been revealed over the last 15 years by the Christchurch Cardioendocrine Research Group, directed by Professor Mark Richards. Dr. Rothwell and colleague Dr. Chris Pemberton are about to extend this research to look at patients’ survivability following a cardiac event who also have high resistin levels. They say resistin may eventually be able to be used as a biomarker for diagnosis and treatment during heart attack. It may also be possible to develop a drug to block resistin and prevent its negative effect on people with heart problems, says Dr. Rothwell.

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