- 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.