(Reuters) – French medical device company Carmat on Friday said it had suspended implants of its Aeson artificial hearts following a quality issue affecting some of its prostheses.
“Quality issues are common events in the life cycle of medical devices, especially during the production ramp-up phase,” said CEO Stéphane Piat in a statement, adding that the suspension was a voluntary and precautionary measure.
Given recurring shortages of donors, Carmat’s device aims to give patients with end-stage biventricular heart failure, a deadly condition where the heart is no longer able to pump blood adequately around the body, an alternative to hospital stays.
Earlier this year, it launched commercially in the European Union after receiving European Commission approval and launched a feasibility study in the United States.
Following the first implant in the Netherlands, Stéphane Piat said the device had been implanted in eight countries.
Carmat was not immediately available for comment.
(Reporting by Sarah Morland and Valentine Baldassari, Editing by Louise Heavens)