May 13th 2020
Paris, May 13, 2020 – 5.45 pm CEST
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 “Centers for Medicare & Medicaid Services” (CMS) has approved coverage of the device and routine care items and services supplied to Medicare beneficiaries to be enrolled in the clinical feasibility study.
The approval confirms the Food and Drug Administration (FDA) Category B designation of the device, which refers to a non-experimental/investigational device for which initial questions of safety and effectiveness have been resolved. It enables the company to accelerate its discussions with the purchase departments, research contract offices and institutional review boards (IRB) at the 7 sites selected for the study. As a reminder, CARMAT has already obtained the conditional approval of two IRB.
The study aims to include 10 transplant-eligible patients, and the primary endpoint corresponds to patient survival at 180 days after the implant or a successful heart transplant within 180 days of the implant.
Stéphane Piat, Chief Executive Officer of CARMAT, said: “This approval of CMS coverage marks a very important milestone for CARMAT, as it substantially supports its development in the United States. Indeed, hospitals will be able to receive payments for the device, routine care items and services during the clinical study. Given the ongoing discussions at the study centers, and subject to the positive evolution of the COVID-19 situation, we expect patient enrolment to begin in Q4 2020, as planned.