Genesis MedTech announced that its J-Valve Transfemoral (TF) System has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA). The heart valve received the designation for the proposed indication of treatment of severe native aortic regurgitation (AR) and AR-dominant mixed aortic valve disease in patients who are judged by a heart team to be eligible for the device and to be at high risk for open surgical aortic valve replacement.
This novel technology is designed for patients with aortic valvular disease. Aortic regurgitation is a common condition that can lead to heart failure. The J-Valve transcatheter aortic valve replacement procedure is performed through a minimally invasive transvascular approach, without the need for open-heart procedure or extracorporeal circulation.
The system utilizes an anchor mechanism and a stent frame that expands to attach the device to a failing valve. By helping to restore normal blood flow out of the heart and into the body, the J-Valve TF system can potentially reduce and/or improve symptoms of heart failure including breathing trouble, chest pain and fatigue.
J-Valve TF System consists of two key components, the J-Valve TF Bioprosthesis and the J-Valve TF Delivery Device. The bioprosthesis consists of bovine pericardium leaflets, a nitinol stent frame covered with polyester fabric and a nitinol anchor ring. The delivery device is used to position the bioprosthesis in the native aortic valve.
The Breakthrough Device designation underscores the significance of this innovative development for cardiovascular patients, according to Genesis MedTech. Under the program, JC Medical will receive prioritized review and interactive communication with the FDA throughout the premarket review phase. To achieve Breakthrough Device designation a device must demonstrate a reasonable expectation that it could provide for more effective treatment or diagnosis of the disease or condition identified in the proposed indications for use.
“We are hopeful that these designations will aid in providing timely treatment for a condition that currently lacks any transcatheter valves approved in the U.S.,” said Dr Mark A. Turco, chief executive officer of JC Medical and president of Vascular Intervention North America at Genesis MedTech. “We look forward to continuing our work with the FDA to bring this life-saving technology to patients in need.”
Photo via Genesis Medtech