Carmat decided to withdraw its initial request to resume artificial heart implantation

News Hour:

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, reports Reuters.

“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

“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.


This article has been posted by a News Hour Correspondent. For queries, please contact through [email protected]
No Comments

Join Epidemiology Congress 2019

Translate this News

Join the Facebook Group

Click here to join the Facebook group of News Hour

Popular Posts

Sacred Games exposes Rajshri Deshpande nude [video]
Banglalink and Facebook jointly launched the campaign "Learn More, be More"
SRK as Satyajit Ray! Here is the truth behind the poster
Anurag Kashyap shoots Kubra Saith 7 times nude and made her cry for frontal nudity scene [Video]
Huawei introduces EMI facilities for smartphone purchase in Bangladesh
World Heart Day rally organized in Guwahati


News of the Month

February 2017
« Jan   Mar »
Scroll Up
%d bloggers like this: