TMVI – BIBA Medtech Insights

Approval of Tendyne TMVI device means physicians now have a portfolio of options for treating mitral regurgitation

In January this year, Abbott made history when it became the first company in the world to receive market approval for a transcatheter mitral valve implantation (TMVI) device. Its Tendyne system now has a CE-mark indication for the management of patients with mitral regurgitation who cannot undergo mitral valve surgery or percutaneous edge-to-edge repair [...]

Medtronic receive FDA nod for feasibility trial of its Intrepid transcatheter mitral valve

Intrepid Medtronic has received FDA approval to begin an early feasibility study for its Intrepid transcatheter mitral valve implantation (TMVI) system using a minimally-invasive transfemoral access approach. A press release reports that this announcement builds upon primary endpoint outcomes of the Intrepid TMVI clinical trial (APOLLO), which showed that TMVI (via the [...]