"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.
[to top of second column] |
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)
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