Genesis MedTech has announced that its J-Valve transfemoral (TF) system has been granted breakthrough device designation by the US Food and Drug Administration (FDA).
The valve has been granted breakthrough device 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 (SAVR).
The 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 implant (TAVI) procedure is performed through a minimally invasive transvascular approach, without the need for open-heart procedure or extracorporeal circulation.
The system utilises an anchor mechanism and a stent frame that expands to attach the device to a failing valve.
The J-Valve TF system consists of two components including the J-Valve TF Bioprosthesis and the J-Valve TF delivery device. The bioprosthesis is comprised 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.
“We are hopeful that these designations will aid in providing timely treatment for a condition that currently lacks any transcatheter valves approved in the USA. We look forward to continuing our work with the FDA to bring this life-saving technology to patients in need,” stated Mark A Turco, CEO JC Medical and president of vascular intervention North America at Genesis MedTech.
Warren Wang, chairman & CEO of Genesis MedTech Group, said: “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.”