The Mitral Contour System combines a proprietary, implantable device with a percutaneous catheter delivery system. The implantable device consists of a proximal anchor and a distal anchor connected by a shaping ribbon.
The approval was based on the results obtained through the Amadeus and Titan clinical trials of the Carillon system which demonstrated reductions in FMR and improvement in functional capacity and quality of life.
Cardiac Dimensions president and CEO Rick Stewart said they are delighted to have achieved this milestone, which allows them to distribute Carillon throughout Europe.
“We are pleased to have the opportunity to further substantiate our initial clinical experiences through the commencement of the Titan II trial,” Stewart said.