Canadian Regulatory Authorities Approve 3f(R) Aortic Bioprosthesis for Sale
Company Updates Financial Outlook for 2008
MINNEAPOLIS, Jan. 31 /PRNewswire-FirstCall/ -- ATS Medical, Inc. (Nasdaq: ATSI), manufacturer and marketer of state-of-the-art cardiac surgery products and services, today announced it has received a request for additional information and clarification from the US Food and Drug Administration (FDA) regarding its PMA approval application for its ATS 3f(R) Aortic Bioprosthesis. Additionally, the Company announced the same valve has been approved by the Canadian regulatory authorities for sale in Canada.
"We look forward to working closely with the FDA to provide the information requested and answer conclusively their questions during the first quarter," commented Michael Dale, President and CEO of ATS Medical. "Based on the nature of the questions received, we remain confident that the ATS 3f(R) Aortic Bioprosthesis will receive PMA approval but the approval may not occur until the second half of 2008."
The PMA for the ATS 3f(R) Aortic Bioprosthesis is supported by data from 405 patients implanted with the heart valve and included over 900 patient years of follow-up data. The clinical results for the ATS 3f(R) Aortic Bioprosthesis met all the FDA Objective Performance Criteria (OPC) used for assessing clinical data.
The FDA's request for additional information was primarily related to
the in-vitro testing submitted in the original IDE application. The Company
is confident it can provide in
|SOURCE ATS Medical, Inc.|
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