Paris, December 23, 2021 – 7 am CET
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, announces the completion of investigations on its prostheses.
Following the occurrence of a quality issue affecting some of its prostheses, CARMAT had announced, on December 3, 2021, the voluntary and temporary suspension of implants of its Aeson® artificial heart. The company has subsequently carried out a very rigorous investigation of the situation.
This investigation, which is now complete, has enabled the root causes of the quality issue to be identified, and the changes required to prevent its reoccurrence to be determined.
The outcome of the investigation will now be shared with the notified body (DEKRA) and the competent authorities (specifically the ANSM in France and the Food & Drug Administration in the United States), starting from this week. The discussions with DEKRA and the competent authorities are expected to take a few weeks and lead to an agreed schedule to resume implants.
The company plans to provide a further update in January 2022, including a web conference, the date of which will be communicated in due course.
Stéphane Piat, Chief Executive Officer of CARMAT, commented: “After more than 2 weeks of in-depth investigation, I am glad that our teams were able to identify the root causes of the quality issue that occurred, and to propose corrective actions. Given the significant unmet need for patients suffering from end-stage biventricular heart failure who cannot benefit from a heart transplant, and the strong demand for Aeson® from many doctors and hospitals, we will now work diligently with all regulatory stakeholders in order to resume implants as soon as possible while keeping quality and patient safety as our top priorities”.