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Carmat to resume implants of Aeson artificial heart in October

By Reuters

-French artificial heart maker Carmat said on Monday it would resume implants of its Aeson artificial heart in October, after it suspended them in December because quality issues affected some of the devices.

“A rigorous investigation concluded that quality defects on two distinct components of the prosthesis were the root cause of these issues,” the group said in a statement.

Following corrective action to prevent these defects and taking account of production lead-times, new prostheses should be available by October 2022, Carmat said, specifying it had sufficient resources to finance its activities through to July.

In December, Carmat said it had completed an internal investigation into the quality issues that led to the suspension of its device implants earlier in the month.

Since the news, Carmat shares have lost almost 30% in value and closed at 16.74 euros on Monday, compared to its pre-suspension price of 24.20 euros.

Given recurring shortages of donors for heart transplants, Aeson is intended to treat patients with end-stage biventricular heart failure, a potentially fatal condition when the heart is no longer able to pump blood adequately around the body.

It launched commercially as a “bridge to transplant” last year after receiving the CE marking, which indicates a product is made to European Economic Area standards. In the United States, it is not available commercially, but is being used within clinical trials.