In October last year, Medtronic (Dublin, Ireland) launched a pivotal trial of its Intrepid transcatheter mitral valve replacement system following an FDA investigational device exemption. Early results of the trial showed procedural success and reduction in mitral regurgitation. It was successfully implanted in 98% of patients who showed notable reductions in mitral regurgitation with patients experiencing none, trace or mild mitral regurgitation compared to baseline.
The Intrepid system features self-expanding, dual-stent technology with replacement tissue heart valve to allow for catheter-based implantation.
Medtronic paid $458 million for Twelve and its transcatheter mitral valve implant in August 2015.