Developed by JC Medical, the U.S.-based Genesis subsidiary, J-Valve holds FDA breakthrough device designation. Its breakthrough designation covers the treatment of severe native aortic regurgitation (AR) and AR-dominant mixed aortic valve disease.
Patients eligible for the valve have a high risk for surgical aortic valve replacement. The procedure takes place through a minimally invasive, transfemoral approach. It eliminates the need for open-heart procedures or extracorporeal circulation. Genesis MedTech says its design can potentially help treat aortic valve regurgitation. The company believes this remains an underserved population by the treatment options in the U.S.
Genesis MedTech’s FDA-approved early feasibility study involved patient enrollment at five c…