FDA Clears ATS Simulus Semirigid Annuloplasty Band


July 6, 2009

July 6, 2009 - ATS Medical Inc. today said the FDA cleared the first implant of the ATS Simulus Semirigid Annuloplasty Band, which was developed through the company’s collaboration with Genesee BioMedical and represents the latest addition to the expanding portfolio of valve repair products.

This product’s clinical applications expand the existing therapeutic options for surgeons and their patients. The Simulus Semirigid Band is 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, the company said.

“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,” said Robert F. Hebeler Jr., M.D., who performed the first implant of the product at Heart Hospital Baylor in Plano, Texas. “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 Semirigid Band easy to implant.”

For more information: www.atsmedical.com