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FDA Class III Category Creates Hurdles for Percutaneous Heart Valve Approvals in the US

Tuesday, April 13, 2010 General News J E 4
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WALTHAM, Mass., April 13 According to Millennium Research Group (MRG), the global authority on medical technology market intelligence, the rigorous FDA approval process is creating major hurdles for percutaneous heart valve device manufacturers. Although percutaneous aortic valves and percutaneous mitral valves gained CE mark approval in Europe in 2007 and 2008, respectively, these devices are not expected to launch in the US market until 2011 and 2012.

Percutaneous heart valve devices, delivered by catheter to the diseased heart valve, have rapidly become one of the most revolutionary and scrutinized areas of research and development in the cardiovascular device industry. These devices have the potential to extend treatment to the approximately 100,000 American patients who are diagnosed with heart valve disease but remain untreated by surgical heart valve repair and replacement. However, the FDA has designated percutaneous heart valves as Class III, the highest-risk class for devices, due to the serious risks posed to patients by device failure. As a result of this Class III labeling, manufacturers must engage in a rigorous clinical evaluation to prove device safety in order to gain FDA approval.

"The biggest investments in percutaneous heart valves are seen in the aortic segment, including Medtronic's CoreValve Percutaneous System and Edwards Lifesciences' SAPIEN device, which are expected to enter the US in 2011" says Andrea Bettello, Analyst at MRG. "Abbott Vascular, which acquired Evalve in late 2009, is expected to launch its edge-to-edge percutaneous mitral valve in 2012. The market's greatest hurdles involve approvals for mitral valves incorporating the complex annuloplasty technique; these devices aren't expected to enter the US market before 2015."

Despite weathering a longer approval process, percutaneous heart valve devices will be adopted at a faster rate than in Europe when they finally reach the US market. The availability of positive long-term clinical data from the procedures already performed in Europe, established physician training programs, and a higher number of facilities able to perform the procedures will prompt physician uptake.

MRG's US Markets for Heart Valve Devices 2010 report provides critical insight into emerging trends that will fuel growth in the heart valve device market, including the market entry of percutaneous heart valve technology. The report also discusses trends in the conventional heart valve market, including tissue and mechanical heart valves and annuloplasty devices. The report provides a complete breakdown of unit sales, average selling prices, and revenues by device type, including five-year forecasts, up-to-date market shares, and in-depth qualitative insights.

About Millennium Research Group

Millennium Research Group (www.MRG.net), a Decision Resources, Inc. company (www.DecisionResourcesInc.com), is the global authority on medical technology market intelligence and the leading provider of strategic information to the healthcare sector. The company provides specialized industry expertise through multiclient market research, ongoing Marketrack(TM) projects, customer behavior tracking, facility-level procedure forecasting, and customized solutions.

About Decision Resources, Inc.

Decision Resources, Inc. is a cohesive portfolio of companies that offers best-in-class, high-value information, and insights on important sectors of the healthcare industry. Clients rely on this analysis and data to make informed decisions. Please visit Decision Resources, Inc. at www.DecisionResourcesInc.com.

All company, brand, or product names contained in this document may be trademarks or registered trademarks of their respective holders.

For more information, contact: Amy Krohn Millennium Research Group 416-364-7776 ext. 101 akrohn@mrg.net Chris Comfort Decision Resources Inc. 781-296-2597 ccomfort@dresources.com

SOURCE Millennium Research Group
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