CARMAT announces FDA conditional approval to initiate US clinical feasibility study of its total artificial heart

  • CARMAT provided sufficient data to support the initiation of a human clinical study
  • Study to include 5 patients in selected renowned US institutions

Paris, September 12, 2019 – 6.00 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 US Food and Drug Administration (FDA) has conditionally approved[1] the Company’s Investigational Device Exemption (IDE) application to initiate a US Early Feasibility Study (EFS) of its total artificial heart.
The EFS protocol includes 5 transplant-eligible subjects limited to a network of 7 US renowned institutions. CARMAT will submit study documents to the Institutional Review Boards (IRB) of the selected study sites and may begin enrolling patients in the study upon the first IRB approval.
CARMAT is invited to present the protocol of the EFS at the 2019 symposium on mechanical support for the heart and lung of the American Association for Thoracic Surgery (AATS) on September 20, 2019 in Houston (Texas).
Stéphane Piat, Chief Executive Officer of CARMAT, says: “The conditional approval to start a US study marks a significant milestone for CARMAT and the mechanical circulatory support field in general. This approval demonstrates the confidence of the FDA in our ability to conduct this feasibility study and reflects the high need for a safe and efficient solution for patients suffering from biventricular heart failure while waiting for a donor heart. We have already selected potential study sites and will immediately begin the submission process with the IRBs and research contract offices.”

[1] If an IDE application is approved with conditions, the sponsor may begin subject enrollment with the number of subjects and investigational sites specified in FDA’s decision letter upon receipt of Institutional Review Board (IRB) approval.