Genesis MedTech has secured breakthrough device designation from the US Food and Drug Administration (FDA) for its J-Valve Transfemoral (TF) System.
The company has developed the technology to treat patients with aortic valvular disease.
The device has received breakthrough status for its use in treating severe native aortic regurgitation (AR) and aortic valve disease characterised by dominant AR in patients.
It comprises the J-Valve TF Bioprosthesis and the J-Valve TF Delivery Device components.
The bioprosthesis includes bovine pericardium leaflets, a nitinol anchor ring and a nitinol stent frame covered with polyester fabric.
The delivery device helps place the bioprosthesis within the native aortic valve.
A minimally invasive transvascular approach helps carry out the J-Valve transcatheter aortic valve replacement procedure.
The device deploys an anchor mechanism and an expanding stent frame to attach to a failing valve.
It can potentially alleviate heart failure symptoms such as chest pain, fatigue and breathing trouble by aiding in the restoration of normal blood flow from the heart to the body.
Genesis MedTech Group chairman and CEO Warren Wang 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.”
