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.
-- 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
|SOURCE ATS Medical, Inc.|
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