Genesis MedTech announced today that it completed enrollment in its U.S. early feasibility study for its J-Valve transfemoral TAVR system.
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 centers in the U.S. It focuses on evaluating symptomatic individuals with severe AR. The company plans to present data on patients who received treatment with J-Valve later this year.
J-Valve remains investigational in the U.S. and Canada.
“This accomplishment would not have been possible without the dedicated efforts of the investigators and research teams involved,” said Dr. Mark A. Turco, CEO of JC Medical and president of vascular intervention North America at Genesis MedTech. “We look forward to the data and learnings as well as the initiation of our upcoming Pivotal Trial.”