MINNEAPOLIS, Minnesota — Cardiology device maker ATS Medical Inc. (NSDQ:ATSI) announced the completion of the first commercial implants of its recently cleared sutureless aortic valve.
The procedures using the 3f Enable Aortic Bioprosthesis were performed in Switzerland at the University of Berne Hospital, according to a statement from the Minneapolis company. The unspecified number of patients are “recovering with no complications.”
CEO Michael Dale called the procedures a “major milestone” for the company, which eventually hopes to bring the valve to the traditional surgery market. Dale didn’t immediately return a call.
ATS says the Enable, which received European regulatory clearance in December, is the first surgical aortic valve replacement approved for commercial use that is implanted using a sutureless technique. The device can be folded to allow placement through a small incision and then expanded once inside a patient. It allows for less-invasive aortic valve replacement and shorter procedure times than other commercially available alternatives, the company says.
ATS’ next-generation Enable valve will be designed for use in beating-heart procedures. The company expects to perform its first human studies involving beating-heart patients sometime this year, with commercialization coming a year or two later. Commercializing a valve for beating-heart patients would open up new markets for the company by providing an avenue to patients who are poor candidates to endure conventional surgery or prefer a more minimally invasive solution, according to the statement.
The company’s stock price has taken a bit of a beating in January, though it has rebounded slightly in recent days. Earlier this month, ATS announced that it expects losses for the fourth quarter and full year of 2009. The company blamed the worse-than-expected projections on slow growth in its heart valve and heart surgery businesses. However, ATS said it expects sales to pick up in the second half of this year as it expands the rollout of its the sutureless Enable valve.