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Medtronic on go with feasibility study of Intrepid TTVR in heart valve disease

Sep. 09, 2020 10:14 AM ETMedtronic plc (MDT) StockMDTBy: SA News Team
  • The FDA has approved Medtronic's (MDT +1.9%) early feasibility study of the Intrepid Transcatheter Tricuspid Valve Replacement (TTVR) system in patients with severe, symptomatic tricuspid regurgitation, a disease in which the damaged tricuspid valve allows blood to flow back into the heart's upper right chamber causing eventual heart failure or death.
  • Medtronic recently received Breakthrough Device Designation by the FDA for the Intrepid TTVR system. The designation, akin to Breakthrough Therapy status for a drug, provides for more intensive guidance on development by the FDA, the involvement of more senior agency personnel, the assignment of a case manager and priority review of the marketing application.

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