ATS Medical, Inc. (ATS), has received FDA approval to initiate the clinical trial for ATS 3f Aortic Bioprosthesis, in which the device will be implanted in younger aortic valve replacement patients who have not been previously studied in a controlled and scientific manner.
This new FDA approved clinical study will enroll patients younger than 60 years of age, with half of the population younger than 50 years of age. The Company believes that this study will ultimately demonstrate the safety, efficacy and durability of the ATS 3f Aortic Bioprosthesis in this new patient population, while illustrating the performance necessary to maintain the active lifestyle of the younger population.
The ATS 3f Aortic Bioprosthesis is an aortic valve designed to function just like a native valve. Its tubular design was inspired by how a native valve forms in utero, as a tube with sides that collapse when external pressure is applied. The primary benefit of the ATS 3f Aortic Bioprosthesis is its tubular design and that it restores physiologic non turbulent blood flow and native-like stress distribution to the aortic root. This valve design provides surgeons and patients with a potentially more durable solution to aortic valve replacement.
ATS Medical is working diligently on hospital selection and patient enrollment will commence immediately after Institutional Review Board approval has been granted at each site. We are encouraged by the FDA approval to pursue this 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, said Astrid Berthe, Vice President of Regulatory Affairs.