Carmat withdraws initial request to resume artificial heart implants

Send a link to a friend  Share

[February 07, 2017]  (Reuters) - Artificial heart maker Carmat said on Monday it had decided to withdraw its initial request to France's national drugs agency (ANSM) to resume trial implantations.

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

[to top of second column]

"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)

[© 2017 Thomson Reuters. All rights reserved.]

Copyright 2017 Reuters. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.


Back to top