The news boosted its stock price.

The French company Carmat announced on Tuesday that it “has obtained the necessary authorizations to resume the implantations” of its Aeson artificial heart, after a suspension at the end of 2021. The certifying body Dekra “approved all the changes made by Carmat in response to the problems [ of] quality which had led the company to voluntarily suspend temporarily, at the end of 2021, all the establishments of Aeson”, indicates the group in a press release.

"This approval allows Carmat to take over Aeson's facilities on a commercial basis in the European Union and in other countries recognizing the 'EU marking'", he adds.

Carmat wishes to "resume soon, gradually,

Investors welcomed the news: the stock price rose 6.67% to 13.28 euros around 9:25 a.m., after jumping more than 10% in the first exchanges.

Despite this increase, over the year, the stock market valuation fell by almost 35%.



The group had already indicated in January to expect “a resumption of settlements in October 2022, after obtaining the green light from these authorities”.

Carmat had decided in December 2021 to suspend them after incidents that affected some of its prostheses.

An investigation concluded that quality defects on two separate components of the prosthesis were the cause of these problems.

Corrective actions have been undertaken with the horizon of autumn 2022 for the resumption of settlements, he had previously indicated.

Carmat had obtained CE marking in Europe in December 2020 for its heart, as a “bridge to transplantation”, that is to say for patients awaiting heart transplantation.

Since its first commercialization in July 2021, it has implanted seven Aeson cores, five in Germany and two in Italy.

This heart aims to offer a therapeutic alternative to patients suffering from end-stage biventricular heart failure.

Health

Artificial heart: Carmat raises 40.5 million euros and hopes to resume implantations

Health

Artificial heart: Carmat has identified the origin of the "quality problem"

  • Health

  • carmat heart

  • Artificial heart

  • Surgery