A Medical Device Daily

FDA has asked for more information and clarification regarding a pre-market approval (PMA) 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.

“We look forward to working closely with the FDA to provide the information requested and answer conclusively their questions during the first quarter,” said Michael Dale, president/CEO of ATS. “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 PMA application for the device is supported by data from 405 patients implanted with the heart valve and included more than 900 patient years of follow-up data, according to ATS. The clinical results for the 3f aortic bioprosthesis met all the FDA objective performance criteria used for assessing clinical data, the company said.

The agency’s request for more information was primarily related to the in vitro testing submitted in the original IDE application, ATS said. 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.

ATS also reported an update to its financial guidance for 2008 and its reporting timeline for 2007 year-end results. The company said it anticipates releasing preliminary sales data for the fourth quarter and full-year 2007 next week and will report full-year 2007 operating results Feb. 25. ATS said it expects that its full-year 2007 revenue will be between $49 million and $50 million.

For full-year 2008, ATS is revising its revenue estimate to $60 million to $64 million instead of $65 million to $70 million. The revised guidance includes about $2 million to $3 million of worldwide revenue from the company’s tissue valves.

“The delay in our ability to market the tissue value in the U.S. is expected to result in a modest reduction in our growth expectations for 2008. However we still expect to report revenue growth of approximately 25% for 2008,” Dale said. “Additionally, we continue to believe the strong growth of our mechanical valve, heart valve repair and surgical ablation franchises will enable us to be profitable in the fourth quarter of 2008 and will provide cash flow adequate to fund the business until we are cash-flow positive.”