Sam Brusco, Associate Editor08.02.23
Genesis Medtech has earned breakthrough device designation from the U.S. Food and Drug Administration (FDA) for its J-Valve transfemoral (TF) system, for the indication to treat severe native aortic regurgitation (AR) and AR-dominant mixed aortic valve disease in patients judged by a heart team to be eligible and at high risk for open surgical aortic valve replacement.
The J-Valve transcatheter aortic valve replacement (TAVR) surgery is performed through a minimally invasive transvascular approach without needing an open-heart surgery or extracorporeal circulation. The system uses an anchor mechanism and stent frame that expands to attach the device to a failing valve.
J-Valve’s components are the J-Valve TF bioprosthesis and TF delivery device. The bioprosthesis is made of bovine pericardium leaflets, a nitinol stent frame covered with polyester fabric, and a nitinol anchor ring.
"We are hopeful that these designations will aid in providing timely treatment for a condition that currently lacks any transcatheter valves approved in the US. We look forward to continuing our work with the FDA to bring this life-saving technology to patients in need," Dr. Mark A. Turco, CEO JC Medical and President of Vascular Intervention North America at Genesis MedTech, told the press.
Warren Wang, chairman and CEO of Genesis MedTech Group added, "We believe the Breakthrough Device designation for the J-Valve TF System is a testament to the innovative spirit and dedication of our team at Genesis MedTech. We are committed to developing cutting-edge medical devices that address unmet clinical needs and improve patient outcomes, and this designation is a significant milestone in that journey."
The J-Valve transcatheter aortic valve replacement (TAVR) surgery is performed through a minimally invasive transvascular approach without needing an open-heart surgery or extracorporeal circulation. The system uses an anchor mechanism and stent frame that expands to attach the device to a failing valve.
J-Valve’s components are the J-Valve TF bioprosthesis and TF delivery device. The bioprosthesis is made of bovine pericardium leaflets, a nitinol stent frame covered with polyester fabric, and a nitinol anchor ring.
"We are hopeful that these designations will aid in providing timely treatment for a condition that currently lacks any transcatheter valves approved in the US. We look forward to continuing our work with the FDA to bring this life-saving technology to patients in need," Dr. Mark A. Turco, CEO JC Medical and President of Vascular Intervention North America at Genesis MedTech, told the press.
Warren Wang, chairman and CEO of Genesis MedTech Group added, "We believe the Breakthrough Device designation for the J-Valve TF System is a testament to the innovative spirit and dedication of our team at Genesis MedTech. We are committed to developing cutting-edge medical devices that address unmet clinical needs and improve patient outcomes, and this designation is a significant milestone in that journey."