CARMAT receives FDA approval to use the new version of its artificial heart in the US Early Feasibility Study (EFS)
CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to fulfill an unmet medical need by providing a therapeutic alternative to people suffering from end-stage biventricular heart failure, today provides an update on its early feasibility study (EFS) in the United States.
The FDA has granted CARMAT approval to use the new version of its artificial heart in the EFS. This new version includes certain improvements in the prosthesis and the wearable system based on clinical experience gained in the PIVOTAL study. The company believes that this latest version should further improve patient safety and quality of life.
In view of this, the Company confirms that it expects the first enrolments in the EFS in Q1 2021.
As a reminder, CARMAT obtained the approval from the Centers for Medicare & Medicaid Services (CMS) for the reimbursement of the device and associated services within the framework of this study in May 2020.
Stéphane Piat, Chief Executive Officer of CARMAT, says: “We are pleased to provide this new version of our artificial heart, which is similar to our CE-marked product, to the US study centers. Despite the Covid-19 pandemic, we were able to train and initiate three of them before the end of 2020. These centers are now ready to enroll patients. We also intend to pursue the training and initiation of additional selected centers.”