FDA greenlights ATS Medical aortic valve replacement study

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The FDA has approved a U.S. clinical study of ATS Medical, in which cardiac surgeons will implant the ATS 3f Aortic Bioprosthesis in a younger aortic valve replacement patient population that has not been previously studied in a controlled manner.

The study will enroll patients younger than 60 years of age, with half of the population younger than 50 years of age. The Minneapolis-based company said the tubular design of ATS 3f Aortic Bioprosthesis was inspired by how a native valve forms in utero: as a tube with sides that collapse when external pressure is applied.

ATS said it is working on hospital selection and patient enrollment, which will commence after Institutional Review Board approval has been granted at each site.