ATS Medical receives European OK for aortic valve

AP News
Posted: Dec 07, 2009 2:18 PM

Shares of ATS Medical Inc. climbed Monday after the company announced that it received approval to distribute its sutureless aortic heart valve in the European Union.

The Minneapolis company said its ATS 3f Enable Aortic Bioprosthesis is the first surgical aortic valve replacement approved for use that is implanted without suturing. The valve includes a self-expanding frame that holds it in "optimal position," the company said in a statement.

"This valve is an important step toward the goal of reducing procedure time and allowing for a more minimally invasive approach to conventional valve surgery," said Dr. Jerzy Sadwoski in the statement. Sadwoski, a professor in Krakow, Poland, performed the first human implant of the Enable valve in January 2005.

Monday's announcement represented "the first approval of the company's truly unique pipeline," Natixis Bleichroeder senior analyst Joshua Zable said in a research note.

"As we have noted in the past, our belief is that (ATS Medical's) true shareholder value lies in the pipeline opportunities, and this is the first step toward monetizing that pipeline," he wrote, noting that he expects a "slowly controlled launch."

ATS shares rose 6 percent, or 18 cents, to $3.08 in Monday afternoon trading. In contrast, the broader Standard & Poor's 500 index was up less than 1 percent.