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ATS Medical Announces CE Mark Approval for the ATS 3f Enable Bioprosthesis
Date:12/7/2009

"We are very excited to obtain the world's first approval for a surgical sutureless heart valve. This initial offering in the Enable platform is an important first step in bringing disruptive technology to the traditional surgical market. Ultimately, we envision the Enable platform facilitating minimally invasive procedures for patients with conventional surgical indications," stated Michael Dale, President and CEO of ATS Medical. "Additionally, by reducing procedural time and the trauma incurred with current conventional surgical procedures, we believe Enable may also become a viable solution for certain patients who are currently considered too sick for surgery."

Commercialization of the Enable valve will commence with a controlled market release at select surgical centers in Europe. These sites will serve as "Centers of Excellence" where surgeons throughout Europe will be trained in the state-of-the-art techniques used for implanting the Enable valve and will be instrumental in the development and launch of future generations of the ATS 3f Enable platform. Release of the second generation Enable is expected in the latter half of 2010.

The Company is continuing to develop sutureless tissue valve technology for use in beating heart procedures based in part on the characteristics of the next generation of Enable valves. First-in-man studies of these novel technologies are targeted for 2010. Commercialization of a beating heart solution could occur within one to two years thereafter. A valve compatible in beating heart procedures would enlarge the Company's market opportunity by providing a solution for those patients who are poor candidates to endure conventional surgery.

About ATS Medical

ATS Medical, Inc. is dedicated to 'Advancing The Standards' of cardiac surgery through the development, manufacturing and marketing of innovative products and services for the treatment of structural heart dise
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SOURCE ATS Medical, Inc.
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