Medtronic Gets FDA Breakthrough Designation for Transcatheter Valve System

Medtronic has gone ahead with an early feasibility study for its Intrepid transcatheter valve system after receiving the FDA’s Breakthrough Device designation.

The system, which is being developed to treat tricuspid valve regurgitation, is implanted in the patient using a transfemoral delivery catheter. The feasibility study will evaluate the device in patients with severe, symptomatic tricuspid regurgitation. It is also being studied as a treatment for symptomatic mitral-valve regurgitation.

"The clinical experience generated during this initial study phase will be critical for the future of the therapy, as many of these patients are not good candidates for traditional surgical tricuspid valve interventions due to their poor right-heart functions," said Vinayak Bapat, the study’s co-principal investigator.