Medtronic Scores Breakthrough Designation for Transcatheter Tricuspid Valve

Medtronic Scores Breakthrough Designation for Transcatheter Tricuspid Valve

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Medical Devices and Diagnostics Industry
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Medtronic reported on Wednesday that FDA has approved an early feasibility study of its Intrepid 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 FDA for the system. The Intrepid TTVR system is an investigational device worldwide.