(ATSI) ATS Medical Gets CE Approval

December 9th, 2009

ATS Medical, Inc. (ATSI) recently received CE Mark approval to distribute the ATS 3f Enable Aortic Bioprosthesis in the European Union. The Enable valve is implanted using a sutureless technique. It is the first surgical aortic valve replacement approved for commercial use. The product will be available immediately in a soft launch in the European Union followed by full launch in the second half of 2010.

The Enable valve is designed to achieve a less invasive aortic valve replacement. It has been seen that most aortic valve surgeries cannot be performed on a minimally invasive basis. This is due to the fact that precise suturing is difficult within the confined space of a minimally invasive procedure. ATS Medical’s Enable valve eliminates this handicap.

Furthermore, the valve also reduces surgical procedure time and the trauma associated with present conventional surgical procedures.

ATS Medical is developing sutureless tissue valve technology for use in beating heart procedures on the basis of characteristics of its next generation of Enable valves. Human clinical test is expected in 2010 and commercialization of the technology is expected within one to two years thereafter.

We think that the new approval will boost demand for ATS Medical’s Enable valve that will drive the company’s top-line. Minneapolis, MN-based ATS Medical develops, manufactures and markets medical devices needed for cardiovascular surgery.

ATS Medical‘s core product, ATS Open Pivot — a mechanical bileaflet heart valve — is used to treat heart valve failure. The company also operates in the tissue valve market. ATS Medical’s main competitor is St. Jude Medical, Inc. (STJ). Other competitors include Medtronic, Inc. (MDT), Carbomedics and Edwards Lifesciences (EW).

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