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 artificial heart in 2019. From a clinical perspective, we have carried out one third of the implantations foreseen within the framework of the pivotal study. This sustained enrollment rate validates the pertinence of our international clinical strategy implemented in highly-specialized medical facilities. It also takes on its full meaning given the performances of the surgical teams, who have been able to substantially reduce the operating time, confirming that the implantation of the Carmat heart is highly controlled and reproducible. These clinical breakthroughs are closely correlated to our industrial development and justify our decision to open a new manufacturing site in Bois-d’Arcy, near Paris. This new site will enable us to produce the prostheses required for the clinical trials and the subsequent commercial phase in compliance with certified processes that meet the demands of industrial production. Lastly, as our project aims to address the issue of heart failure on a global scale, we are delighted to see our discussions with the U.S. FDA progressing towards the initiation of an early feasibility study in the United States, a market with substantial potential for Carmat,” CEO Stéphane Piat said in a prepared statement.
Last May, Carmat saw shares rise after it said French regulators approved the resumption of a clinical trial of the artificial heart.