ATS Medical Announces Second Quart...(and DrugAdministration (FDA) asked ATS t...),Health

Date:8/4/2008

and Drug Administration (FDA) asked ATS to provide additional information and clarification in support of its Premarket Approval Application for the ATS 3f Aortic Bioprosthesis. The Company submitted answers to the FDA in March 2008. Management continues to expect that the ATS 3f Aortic Bioprosthesis will be approved in the second half of 2008.

* ATS 3f Enable(TM) Aortic Bioprosthesis: Enrollment continues to progress with excellent clinical results in the Company's European clinical trial of its Enable sutureless tissue valve, which is designed to provide a less invasive approach for aortic valve replacement. The Company expects to complete enrollment in the CE Mark clinical trial during the third quarter. Regulatory approval for commercialization in Europe is expected in mid-2009.

Mechanical Valves

* ATS Open Pivot AP360(TM) Mechanical Heart Valve: The Company commenced a limited launch of its ATS AP360 Heart Valve in the first quarter. The AP360 is the Company's most competitive Open Pivot product, with the same hemodynamic features as its existing supra annular AP valve but with a revised cuff design to enable easier suturing. Physician response continues to be excellent. The Company has enjoyed ongoing success with the AP360 as evidenced by the addition of several new mechanical valve customers since its launch.

Repair Products

* ATS Simulus(R) Semi-Rigid Ring: A full launch of the Semi-Rigid Ring is underway; initial surgeon feedback has been very positive and contributed to revenue growth of 76.0% in the first half of 2008 compared to the first half of 2007.

"Our second quarter revenue growth was especially strong due to increasing contributions from our non-mechanical valve products," continued Mr. Dale. "While we continue to grow revenue from our core mechanical valve line, our non-mechanical valve revenue grew approximately 153% over the second quarter of 2007, even without contributions from our tissue valve in t
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SOURCE ATS Medical, Inc. Copyright©2008 PR Newswire. All rights reserved

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