ATS Medical Inc. (ATSI) Awarded FDA-Approval for Cardiac Study of Aortic Valve Replacement
ATS Medical Inc. manufactures and markets advanced cardiac surgery products and services through its heart valve disease therapy and surgical ablation of cardiac arrhythmias segments. The company yesterday announced FDA-approval for a first-of-its-kind clinical study in which cardiac surgeons will implant ATS Medical’s ATS 3f® Aortic Bioprosthesis in patients under the age of 60, a population not yet studied in a controlled and scientific manner. Astrid Berthe, vice president of Regulatory Affairs, said the FDA’s decision is a milestone that will raise the bar in aortic valve replacement. "We are encouraged by the FDA approval to pursue this landmark opportunity…