CARMAT announces FDA full approval to initiate US clinical feasibility study of its total artificial heart
- CARMAT has responded to all remaining questions from the conditional approval
- Number of subjects to be enrolled in the study extended to 10 patients
Paris, February 5, 2020 – 5:45 pm CET
CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, announces that the US Food and Drug Administration (FDA) has fully approved the Company’s Investigational Device Exemption (IDE) application to start a US Early Feasibility Study (EFS) of its total artificial heart.
The amended EFS protocol includes 10 transplant-eligible subjects limited to a network of 7 US renowned institutions. The primary endpoint of the study is patient survival at 180 days post-implant or a successful cardiac transplantation within 180 days post-implant. It is a staged study with a progress report of the first 3 patients after 60 days, before the enrollment of the next 7 patients.
CARMAT also obtained conditional approval from two Institutional Review Boards (IRB) and this full FDA approval enables the company to accelerate the discussions with the other IRB and research contract offices at the 7 sites. The company is also working closely with the Centers for Medicare & Medicaid Services (CMS) to obtain a coverage of the costs of the trial, with the objective to start patient enrolment in Q4 2020.
CARMAT will present the EFS protocol at the 2020 symposium on mechanical support for the heart and lung of the American Association for Thoracic Surgery (AATS) on February 14, 2020, in Houston (Texas).
Stéphane Piat, Chief Executive Officer of CARMAT, said: “The full approval to initiate a US study marks another milestone for CARMAT and confirms the trust of the FDA in our ability to conduct the feasibility study of the first bioprosthetic artificial heart in the United States. Considering the ongoing approval procedures with the Institutional Review Boards at the selected centers and discussions on the potential reimbursement of the treatment costs, we expect patient enrolment to start in Q4 2020.”