asked ATS to provide additional information and clarification in
support of its PMA 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 designed to
provide a less invasive approach for aortic valve replacement. The
Company recently implanted the 50th patient in this pivotal trial and
expects to reach enrollment of 100 patients around mid year. The first
regulatory approval for commercialization is expected in mid 2009.
-- 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. Initial
physician response has been excellent and the company expects to see
measurable revenue growth from this new offering in the second quarter.
-- ATS Simulus(R) Semi-Rigid and Adjustable Flexible Rings: Initial launch
and implants have been completed; surgeon feedback has been very
positive and contributed to revenue growth of 28.0% in the first
quarter of 2008 compared to Q4 2007 and 70.4% compared to the first
quarter of 2007. The ATS Simulus Flexible rings and bands are fast
becoming the annuloplasty device of choice among surgeons performing
|SOURCE ATS Medical, Inc.|
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