ATS Medical Announces FDA Clearance and First Implant of New ATS Simulus Semi-Rigid Annuloplasty Band

ATS Medical, Inc., manufacturer and marketer of state-of-the-art cardiac surgery products and services, today announced FDA clearance and the first implant of the ATS Simulus(R) Semi-Rigid Annuloplasty Band. The Simulus Semi-Rigid Annuloplasty Band was developed through the Company's collaboration with Genesee BioMedical and represents the latest addition to the expanding portfolio of valve repair products.

Annuloplasty rings and bands are used in those cases where repair of a patient's heart valve is preferable to replacement of the valve. This new repair product has clinical applications that expand the existing therapeutic options for surgeons and their patients. The Simulus Semi-Rigid Band is specifically designed to respect the natural motion of the mitral annulus during the cardiac cycle allowing for a more physiologic valve repair. This unique characteristic can be particularly important in patients where both the aortic and mitral valves are being treated.

Dr. Robert F. Hebeler, Jr., who performed the first implant of the ATS Simulus Semi-Rigid Band at Heart Hospital Baylor in Plano, Texas commented, "This Simulus Semi-Rigid Band represents the next advancement in annuloplasty repair rings and provides an excellent option for my patients with mitral valve regurgitation. The band retains the natural saddle shape of the mitral valve annulus and preserves mobility during the cardiac phases, particularly in the aorto-mitral junction. These design characteristics make the Simulus Semi-Rigid Band easy to implant."

Michael Dale, President and CEO of ATS Medical added, "We are excited about the growth and innovation we have brought to the annuloplasty repair market. Our portfolio of Simulus annuloplasty products continues to be an important contribution to our heart valve therapy product platform."