Medtronic receives Breakthrough Device designation from FDA

September 09, 2020 – Medtronic plc (Dublin, OH) announced U.S. Food and Drug Administration (FDA) approval of an early feasibility study (EFS) of the Intrepid Transcatheter Tricuspid Valve Replacement (TTVR) system in patients with severe, symptomatic tricuspid regurgitation, a disease in which the diseased, damaged or malfunctioning tricuspid valve allows blood to flow back into the heart’s upper right chamber causing eventual heart failure or death.

The study begins on the heels of a recent Breakthrough Device Designation issued by the FDA for the Intrepid TTVR System.

The Intrepid transcatheter valve is the same valve being evaluated for the treatment of symptomatic mitral valve regurgitation in the transfemoral mitral early feasibility study. The device is implanted using a transfemoral delivery catheter, which assists physicians in delivering and placing the valve through a catheter inserted in the femoral vein.

The Intrepid TTVR system is an investigational device worldwide.

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