Medtronic Inc. (NYSE: MDT) said two-year results from a clinical study demonstrate the durability and efficacy of its CoreValve catheter-based heart valve replacement system.
The 126-patient study in Canada and Europe showed that 73 percent of patients saw their heart-failure symptoms “improve substantially,” according to a statement from Medtronic. During the two-year period, no valve migration or deterioration was reported.
The CoreValve system is designed to replace a diseased aortic valve without open heart surgery or surgical removal of the native valve. The replacement valve is typically delivered through a catheter in a patient’s femoral artery.
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CoreValve received regulatory approval for sales in Europe in March 2007 and has been implanted in more than 10,000 patients. It hasn’t been cleared by the Food and Drug Administration for sales in the U.S.
The overseas market has been a huge driver in recent growth for Medtronic’s cardiovascular business unit, which includes valves and stents. International cardiovascular sales grew 27 percent in fiscal 2010, while the unit’s domestic sales grew just 4 percent.
In March, the company began a 1,000-patient study of the CoreValve system that’s expected to take place at 90 locations and follow patients for five years.
Medtronic acquired the technology with its $700 million purchase of Irvine, Calif.-based CoreValve Inc. in February 2009.
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The company has placed a heavy bet that so-called transcatheter systems will grow more widespread as a less-invasive means of implanting replacement heart valves. Valve replacements done with a catheter could be a better alternative for patients since such procedures don’t require surgeons to crack open a patient’s chest to replace a diseased heart valve.
