FDA Approves ATS 3f Aortic Bioprosthesis

Ruzanna Harutyunyan's picture
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ATS Medical, Inc. (Nasdaq: ATSI), manufacturer and marketer of state-of-the-art cardiac surgery products and services, today announced it has received U.S. Food and Drug Administration (FDA) approval for the ATS 3f Aortic Bioprosthesis.

This is the Company's first entry into the $400-plus Million U.S. tissue valve market. Based on the precept that 'Form Follows Function', the ATS 3f Aortic Bioprosthesis is a revolutionary next generation stentless pericardial aortic tissue valve that is unlike any other replacement valve.

Mimicking the native aortic valve's function as a tubular structure whose sides collapse in response to pressure, the ATS 3f Aortic Bioprosthesis is based on a proprietary valve design that reproduces the functional characteristics of the native aortic valve. This novel design results in a normal distribution of stress on the valve leaflets and laminar, non-turbulent blood flow across the prosthetic valve that is characteristic of a normal, native aortic valve.

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With more than six years of clinical experience confirming excellent safety and efficacy, the ATS 3f Aortic Bioprosthesis' combination of normal blood flow dynamics and improved stress distribution provides surgeons and patients with a potentially more durable and physiologic solution to aortic valve replacement.

As one of the lead investigators in the pivotal clinical trial for the ATS 3f Aortic Bioprosthesis, Dr. Richard Shemin, Robert and Kelly Day Professor of Cardiothoracic Surgery, Chief, Division of Cardiovascular Center Executive Vice Chairman, Department of Surgery, David Geffen School of Medicine at UCLA, is eager to begin implanting the new pericardial tissue valve.

"The tubular design of the ATS 3f valve sets it apart from all other valves. The preservation of the aortic root is an innovative design element that returns native flow, increases coronary perfusion and appropriately distributes cardiac stress. In addition, the ease of implantation and potential for longer term durability makes this an excellent choice for my patients," added Dr. Shemin.

"This FDA approval is our first Class III PMA Approval since the reorganization of ATS Medical in October 2002 to become a leader in the treatment of structural heart disease with a focus on serving the unique requirements of cardiac surgeons," stated Michael Dale, Chairman, President and CEO. "This is a major milestone that will allow ATS Medical to leverage the expertise of our U.S. sales organization and capitalize on the significant brand equity we have established in the marketplace with the ATS Open Pivot heart valve, ATS Simulus annuloplasty products and the ATS CryoMaze surgical ablation product line. Finally, this achievement is a testament to the competence, perseverance and vision of our employees, the founders of 3f and our clinical investigators who for more than six years committed themselves to bring an important solution forward for the advancement of cardiac surgery and patient well being." added Mr. Dale.

The ATS 3f Aortic Bioprosthesis is manufactured in Lake Forest, California, and is the first product within the 3f platform to earn FDA PMA approval. The second generation ATS 3f Enable Aortic Bioprosthesis, which is comprised of the ATS 3f tissue valve mounted in a self expanding nitinol frame, is currently under clinical investigation in select centers in Europe with over 100 implanted patients. ATS Medical expects CE Mark approval of ATS 3f Enable in the first half of 2009.

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