Genesis MedTech Receives FDA Breakthrough Device Designation for the J-Valve™ Transfemoral System
Wednesday, August 02, 2023
Genesis MedTech, a leading medical device company, has announced that its J-Valve™ Transfemoral (TF) System has received FDA Breakthrough Device designation. This designation is for the treatment of severe native aortic regurgitation (AR) and AR-dominant mixed aortic valve disease in high-risk patients who are considered eligible by a heart team for the device.
The J-Valve™ TF System offers an innovative solution for patients with aortic valvular disease, addressing a common condition that can lead to heart failure. The transcatheter aortic valve replacement procedure is minimally invasive, performed through a transvascular approach, avoiding the need for open-heart surgery or extracorporeal circulation. The system's anchor mechanism and stent frame effectively attach the device to the failing valve, restoring normal blood flow and potentially alleviating heart failure symptoms such as breathing difficulties, chest pain, and fatigue.
Comprising two essential components, the J-Valve™ TF System includes the J-Valve™ TF Bioprosthesis and the J-Valve™ TF Delivery Device. The bioprosthesis features bovine pericardium leaflets, a nitinol stent frame with polyester fabric, and a nitinol anchor ring. The delivery device facilitates the precise positioning of the bioprosthesis in the native aortic valve.
Obtaining Breakthrough Device designation signifies the significance of this innovative development for cardiovascular patients. Through the program, Genesis MedTech will receive prioritized review and interactive communication with the FDA during the premarket review phase. To receive this designation, the device must demonstrate a reasonable expectation of providing more effective treatment or diagnosis for the identified disease or condition in the proposed indications for use.