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ATS Medical Announces Record Quarterly and Full Year Revenue
Date:2/25/2008

e 57 patients have been treated for atrial fibrillation using ATS

CryoMaze through minimally invasive access. The results of the study

demonstrate over 90% freedom from atrial fibrillation at six months.

Tissue Heart Valves

-- ATS 3f(R) Aortic Bioprosthesis: The Company's first generation tissue

valve has been approved for sale in Europe and Canada and launch

activities in these geographies are underway. The ATS 3f Aortic

Bioprosthesis represents the Company's first product targeted at the

largest market in cardiac surgery, tissue heart valves.

As announced previously, the Food and Drug Administration (FDA) has

asked ATS to provide additional information and clarification in

support of its PMA for the ATS 3f Aortic Bioprosthesis. The request

relates primarily to in-vitro testing submitted in the original IDE

application. The Company intends to work collaboratively with the FDA

to answer all questions early in 2008. Management remains confident

that the ATS 3f Aortic Bioprosthesis has met or exceeded all of the

requirements and is approvable, but it is now anticipated in the

second half of 2008.

-- ATS 3f Enable(TM) Aortic Bioprosthesis: Enrollment in the Company's

European clinical trial of its Enable tissue valve designed to provide

a less invasive approach for aortic valve replacement continues to

progress with excellent clinical results. The Company expects to

reach enrollment of 100 patients in the pivotal stage of the trial

around mid year, and anticipates its first regulatory approval for

commercialization in 2009.

Mechanical Valves

-- ATS Open Pivot AP360(TM) Mechanical Heart Valve: The Company received

FDA approval of its ATS AP360 Heart Valve in December 2007. The AP360

is the Company's
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SOURCE ATS Medical, Inc.
Copyright©2008 PR Newswire.
All rights reserved

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