Artificial heart developer gains key approval as money troubles continue
Carmat, the French medtech company known for its total artificial heart technology, has received updated CE mark approval that complies with Medical Devices Regulation (MDR) requirements. The new certification covers the use of the company’s Aeson artificial heart as a bridge to heart transplant.
The Aeson device had previously received CE marking for the same indication under the Medical Device Directive (MDD), but the MDD has been replaced as a go-to European standard by MDR. MDR requires more of a company in terms of patient data and post-market surveillance.
This news come at a time of turmoil for the French company. On June 30, for example, Carmat filed for insolvency due to a lack of funds. The company was placed in a receivership procedure the very next day.
The situation is still ongoing. The company reduced its activities during this period to focus on seeking new regulatory approvals and supporting patients who have already received the Aeson artificial heart. Even commercial implants of the Aeson device are on hold at least through the end of August.
“I would like to underline that Aeson is, and currently remains, the only implantable artificial heart being CE-marked and thus marketed in Europe,” Stéphane Piat, Carmat CEO, said in a statement. “In the particular context in which Carmat currently finds itself, this MDR certification is a further independent recognition of Aeson’s quality and performance by health authorities. From a regulatory perspective, we have thus already secured the right to continue marketing Aeson across Europe even beyond 2027, for patients suffering from advanced heart failure. I hope we will successfully get out of the receivership procedure we are currently in, so that patients can effectively continue benefitting from our therapy going forward.”
Piat also emphasized that this updated CE mark approval should help Carmat’s chances of breaking through in the U.S. healthcare market.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.