Carmat updates on artificial heart pivotal trial, plans U.S. feasibility study

Carmat (EPA:ALCAR) today announced updates on its bioprosthetic artificial heart pivotal trial in Europe and said it has submitted files to the FDA seeking an early feasibility trial in the US. The Paris-based company said it has received the regulatory go-ahead to launch its European pivotal trial, looking to implant its bioprosthetic artificial heart in 20 patients with end-stage biventricular heart failure with stable health. The trial’s primary endpoint is the survival of the patients at six months. Carmat said it received clearance to run the trial in France, Kazakhstan, the Czech Republic and Denmark, and that to date 30% of implantations planned for the trial have already been performed. The company said that the trial currently has a 100% implantation success rate and that patients in the trial have a more stable clinical profile than those in its earlier feasibility trial. Carmat added that it has opened a new assembly plant near Paris, which it hopes will be able to meet demand for its pivotal trial. The company said it has pre-submitted a dossier for an early feasibility study of its artificial heart in the US, and that it is hopeful it will be able to engage in a feasibility trial in the US followed by a pivotal trial in pursuit of FDA approval. “We are ramping up our project on all of its strategic routes and are gradually meeting the key milestones that bring us closer each day to meeting our objective of obtaining a CE mark for the Carmat total ar...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiac Implants Cardiovascular Clinical Trials Carmat Inc. Source Type: news