A CD&D

FDA has asked for more information and clarification regarding a pre-market approval application for the ATS 3f aortic bioprosthesis from ATS Medical (Minneapolis), a company that makes products for cardiac surgery.

The heart valve already is approved for sale in Europe and Canada, ATS said.

Michael Dale, president/CEO of ATS, said, "Based on the nature of the questions received, we remain confident that the ATS 3f aortic bioprosthesis will receive PMA approval but the approval may not occur until the second half of 2008."

The company said that its PMA is supported by data from 405 patients implanted with the heart valve and includes more than 900 patient years of follow-up data. The clinical results for the 3 Fr aortic bioprosthesis met all the FDA objective performance criteria used for assessing clinical data, the company said.

It said the agency’s request for more information was primarily related to the in vitro testing submitted in the original IDE application. The company said it is confident it can provide information and analysis to assure FDA that the in vitro data meets all FDA and international valve testing standards and that the ATS 3f aortic bioprosthesis is safe and effective.