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 Medicalâ€™s ATS 3fÂ® 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 FDAâ€™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 in an approved post-market study with the ATS 3f Aortic Bioprosthesis in a younger patient population. We look forward to the outcomes that will demonstrate scientifically that the ATS 3f Aortic Bioprothesis is the highest performing tissue valve available to all patients in need of aortic valve replacement,” Berthe stated in the press release.
The ATS 3fÂ® Aortic Bioprosthesis is designed to replace and function as a â€œnativeâ€ aortic valve. The valve is tubular in design, allowing for flexibility when external pressure is applied, restoring blood flow and the natural stress distribution to the aortic root.
Targeting a younger and more active patient roster, ATS Medical anticipates the study to demonstrate the safety and efficacy of the ATS 3f Aortic Bioprostheis, ultimately providing the durability needed for patients to maintain their active lifestyles after heart surgery.
The company said it is now reviewing and discussing hospital discussion and will begin patient enrollment after it receives Institutional Review Board approval for each facility.