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FDA approves ATS Medical's heart valve products
By E. Janene Geiss
Philadelphia, Jan. 26 - ATS Medical, Inc. said Thursday that the Food and Drug Administration has approved for market release the ATS Simulus annuloplasty product line, expanding the company's portfolio to include the repair segment of the heart valve therapy market.
According to independent estimates, the worldwide repair segment of heart valve therapy is $115 million and growing at 5% to 10% a year, according to a company news release.
ATS Simulus annuloplasty products are available either in a flexible ring - the ATS Simulus FLX-O Ring - or a flexible band - the ATS Simulus FLX-C Band to accommodate various approaches to valve repair.
The valves can be used in both the mitral and tricuspid position, officials said.
Annuloplasty rings and bands are used in those cases where repair of a patient's heart valve is preferable to the complete replacement of the valve. It has been well-documented that the shape of heart valves change during the cardiac cycle, officials said.
The ATS Simulus annuloplasty products are designed to maintain the normal physiologic function of the heart valve. They have been designed with the input of cardiac surgeons with a focus on the ease of implantation, officials said.
Genesee BioMedical, Inc., a Denver-based innovator of cardiac surgery instruments and devices, is the exclusive partner of ATS Medical for the development and manufacture of a full line of annuloplasty products.
"The ATS Simulus annuloplasty product line is yet another vital step in our mission to establish ATS Medical as a leader in cardiac surgery," chairman, president and chief executive officer Michael D. Dale said in the release.
ATS, based in Minneapolis, manufactures and markets products and services focused on cardiac surgery.
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