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# FDA OKs Medtronic Intrepid Early Feasibility Study
- URL: https://www.fdaweb.com/fda-oks-medtronic-intrepid-early-feasibility-study/
- Published: 2020-09-09T12:00:00.000Z
- Updated: 2026-09-14T16:28:03.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5147618

FDA has approved an early feasibility study for Medtronic’s Intrepid Transcatheter Tricuspid Valve Replacement 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 company [says](https://www.marketwatch.com/press-release/medtronic-receives-breakthrough-device-designation-from-fda-begins-early-feasibility-study-for-investigational-intrepidtm-transcatheter-valve-system-for-the-treatment-of-tricuspid-valve-regurgitation-2020-09-09?tesla=y&ref=fdaweb.com) the study follows the agency’s breakthrough device designation for the Intrepid system.

Medtronic says the Intrepid transcatheter valve is the same valve being evaluated for treating symptomatic mitral valve regurgitation in the transfemoral mitral early feasibility study. It says the device is implanted using a transfemoral delivery catheter that assists physicians in delivering and placing the valve.