ATS Receives FDA Clearance For Simulus Semi-Rigid Annuloplasty Ring

Armen Hareyan's picture
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Semi-Rigid Annuloplasty Ring

ATS Medical received FDA clearance for the ATS Simulus Semi-Rigid Annuloplasty Ring.

These semi-rigid rings are the next in a series of mitral valve repair products developed and commercialized through the Company's partnership with Genesee BioMedical. This collaboration has worked closely with cardiac surgeons to create a semi-rigid ring with the unique Flex-Zone anterior segment.

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The ring respects the natural motion of the mitral annulus and its proximity to the aortic valve allowing for a safer, more physiologic valve repair. Annuloplasty rings and bands are used in those cases where repair of a patient's heart valve is preferable to replacement of the valve.

Douglas Murphy, M.D. of St. Joseph's Hospital in Atlanta, Georgia, noted "I have utilized the original ATS Simulus Flexible annuloplasty ring and band in hundreds of surgical cases and have been impressed with its superior handling and suturability. A semi-rigid version coupled with the variety of surgical repair techniques available will now allow us to further individualize and refine each patient's care with an eye towards
continuous outcome improvement."

Michael Dale, President and CEO of ATS Medical commented, "The first results of our collaboration with Genesee BioMedical, ATS Simulus Flexible rings and bands, were introduced in 2006 and employ an innovative braided polyester material that uniquely offers flexibility without elasticity.

The ease and reproducibility facilitated during implant has helped us rapidly carve out a significant niche within the minimally invasive and robotic valve repair market; one that we look to build upon and exceed with our semi-rigid product. We have significantly strengthened our offerings in the approximately $100 million market for valve repair devices where an estimated 50% of current procedures employ semi-rigid devices. This key product approval combined with pending U.S. approvals of our first tissue valve offering, the ATS 3F Aortic Bioprosthesis, and the AP360 Mechanical Heart Valve, further strengthens our ability to achieve our stated goals of positive cash flow and profitability in 2008."

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