ATS Medical Receives FDA Clearance For ATS Simulus Semi-Rigid Annuloplasty Ring

Main Category: Cardiovascular / Cardiology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 27 Oct 2007 - 0:00 PDT

email to a friend   printer friendly   opinions  

ATS Medical, Inc. (Nasdaq: ATSI), manufacturer and marketer of state-of-the-art cardiac surgery products and services, announced U.S. Food and Drug Administration (FDA) clearance for the ATS Simulus(R) 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(TM) anterior segment. 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(R) 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(R) 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(R) Aortic Bioprosthesis, and the AP360(TM) Mechanical Heart Valve, further strengthens our ability to achieve our stated goals of positive cash flow and profitability in 2008."

About ATS Medical

ATS Medical, Inc. provides innovative products and services focused on cardiac surgery. The company, global in scope, is headquartered in Minneapolis, Minnesota. More than 140,000 ATS Open Pivot(R) Heart Valves, which utilize a unique pivot design resulting in exceptional performance and low risk profile, have been implanted in patients worldwide. The ATS 3f(R) brand encompasses multiple tissue heart valve product offerings at varying steps from market introductions to clinical trials to development projects that incorporate less invasive valve replacement technology. ATS Medical's focus on serving the cardiac surgery community is further strengthened by offerings that include ATS Simulus(R) annuloplasty products for heart valve repair, ATS CryoMaze(TM) surgical ablation products, and RTI-Cardiovascular for allograft tissue services. The ATS Medical web site is http://www.atsmedical.com.

Safe Harbor

This Press Release contains forward-looking statements that may include statements regarding intent, belief or current expectations of the Company and its management. Actual results could differ materially from those projected in the forward looking statements as a result of a number of important factors, including the results of clinical trials, the timing of regulatory approvals, the integration of 3f Therapeutics and the surgical cryoablation business of CryoCath Technologies, Inc., regulatory actions, competition, pricing pressures, supplier actions and management of growth. For a discussion of these and other risks and uncertainties that could affect the Company's activities and results, please refer to the Company's filings with the Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2006 and its most recent quarterly report on Form 10-Q.

ATS Medical, Inc.
http://www.atsmedical.com

• Additional
• References
• Citations