|
 ANSM ordered Carmat in December to suspend further implantations
following the death of a fifth patient in October.
In a statement on Monday evening, the company provided details on
the case.
"The patient’s death was due to an interruption in the power supply
system, following incorrect battery handling by the patient, as a
result of which the prosthesis stopped functioning," Carmat said.
Carmat said it intended to file a new request in the near future
when it had gathered the information required by ANSM, but that the
study would remain suspended until a new application was accepted.
Shares in the company closed down 5.3 percent on Monday after the
French daily Le Parisien published an interview with Chief Executive
Stéphane Piat in which he expressed frustration about the trial.
"In France, innovation like the Carmat heart gets blocked, while it
should be the fruit of strong collaboration between the authorities,
the company, specialists, patients ... We are not on the same
wavelength," he said
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"We have met with the American health authority, the FDA. They have
a more pragmatic, more flexible approach," he added later in the
interview.
Shares in the company have lost around a quarter of their value
since the announcement of the first implantation of the artificial
heart in late August.
(Reporting by Alan Charlish; Editing by Kevin Liffey)
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