The company has recently secured FDA breakthrough device status for the Intrepid TTVR system
Medtronic has secured approval from the US Food and Drug Administration (FDA) to begin an early feasibility study (EFS) of the Intrepid transcatheter tricuspid valve replacement (TTVR) system to treat patients with severe and symptomatic tricuspid regurgitation.
The study follows the recent breakthrough device status granted by the FDA for the Intrepid TTVR investigational device.
The tricuspid regurgitation is a disease in which the damaged or malfunctioning tricuspid valve enables blood to flow back into the heart’s upper right chamber, which may lead to heart failure or death.
Medtronic’s Intrepid transcatheter valve is the same valve being assessed to treat symptomatic mitral valve regurgitation in the transfemoral mitral early feasibility study.
The transfemoral delivery catheter will help implant Intrepid transcatheter valve
The transfemoral delivery catheter will be used to implant Intrepid transcatheter valve. The catheter will allow physicians to deliver and place the valve in the femoral vein.
The study co-principal investigator Dr Vinayak Bapat said: “The clinical experience generated during this initial study phase will be critical for the future of the therapy, as many of these patients are not good candidates for traditional surgical tricuspid valve interventions due to their poor right heart functions and are higher risk due to co-morbidities.
“We are optimistic that these early learnings will help fuel additional clinical research and device innovation around this treatable disease.”
In August this year, Medtronic secured FDA approval for the revised commercial labeling of its Evolut TAVR platform to treat bicuspid severe aortic stenosis (AS) patients.
The revised commercial labelling includes recommendations for assessing TAVR as a potential treatment option for bicuspid patients, considering anatomical characteristics, age, long term durability, and the existing clinical data of the patients.