Genesis MedTech Concludes Enrollment for U.S. Early Feasibility Study on J-Valve™ Transfemoral System in Severe Aortic Regurgitation Patients

6 February 2024

Genesis MedTech, a leading player in the medical device industry, has announced the successful completion of enrollment in its United States Early Feasibility Study (EFS) involving the J-Valve™ Transfemoral (TF) System, a specialized transcatheter aortic valve replacement (TAVR) system. This milestone represents a significant achievement for Genesis MedTech and its subsidiary, JC Medical, operating in the United States.

The FDA-approved EFS trial was conducted across five medical centers within the country and focused on evaluating symptomatic individuals suffering from severe Aortic Regurgitation. The J-Valve™ TF System, which has received Breakthrough Device designation, aims to address severe native aortic regurgitation (AR) and AR-dominant mixed aortic valve disease in patients deemed unfit for surgical aortic valve replacement by a heart team. Utilizing a minimally invasive transfemoral approach, the procedure eliminates the need for open-heart surgery or extracorporeal circulation.

The innovative design and functionality of the J-Valve™ TF System offer promising prospects for patients with aortic valve regurgitation, addressing a critical gap in treatment options in the United States. This achievement reflects the dedicated efforts of the investigators and research teams involved in advancing cardiovascular care.