Cardiology device maker ATS Medical Inc. (Nasdaq: ATSI) reported the first commercial implant in China of its stentless heart valve.
The procedure marks an important milestone for ATS as the company tries to strengthen its position in China, which has the potential to be the largest valve replacement market in the world within the next 10 to 15 years, according to Chief Executive Michael Dale.
The Chinese market “has gone from nothing 10 years ago to growth of 15 to 20 percent per annum,” Dale said.
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China has a large and growing population that’s becoming more wealthy and able to afford U.S-style health care. The country is ATS’ largest growth driver, accounting for about 12 percent of ATS’ sales, with Chinese sales nearly doubling for the firm last year, Dale said.
ATS received Chinese regulatory approval to market the valve, the ATS 3f Aortic Bioprosthesis, in March, according to a statement from the company.
Unlike many heart valves on the market, ATS’ 3f Aortic Bioprosthesis doesn’t include a stent, a wire mesh tube that’s inserted into an artery to keep it open. Rather, ATS’ valve is designed as a tube with sides that collapse when external pressure is applied, making it “potentially” more durable, according to the company.
This year could be a pivotal one for ATS. In the second half of 2010, ATS expects to receive European regulatory approval for the next-generation version of its sutureless heart valve, the 3f Enable Aortic Bioprosthesis. In December, the company obtained European clearance to sell the first-generation iteration of the device.
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Launching the next-generation device will be “the most significant business-development effort in the history of the company,” Dale said.
Dale expects by the end of the year that ATS will seek approval from the Food and Drug Administration to conduct clinical trials of the next-generation device.
