PARIS (Reuters) – French artificial heartmaker Carmat said on Thursday it had completed an internal investigation into quality issues that affected some of its prostheses, sending its shares up almost 10 percent in early trade.
“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,” Carmat said, adding it would pass on the findings to regulators, especially in France and the United States, and provide a further update in January.
Carmat said earlier this month it had suspended implants of its Aeson artificial hearts following a quality issue affecting some of its prostheses, prompting its shares to plunge.
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.
Shares in the Paris-listed heartmaker were last 9.73 % higher at 0804 GMT.
(Reporting by Tassilo Hummel; editing by Vinay Dwivedi, Kirsten Donovan)
