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May 3, 2017

Carmat gets ANSM approval to resume its artifical heart trial in France

Carmat has secured approval to resume the clinical trial of its artificial heart from the French National Agency for Medicines and Health Products Safety (ANSM).

Carmat has secured approval to resume the clinical trial of its artificial heart from the French National Agency for Medicines and Health Products Safety (ANSM).

Being developed as a therapeutic alternative for end-stage biventricular heart failure patients, Carmat's implantable prosthesis comes with an external power supply system.

Carmat inserted its bioprosthetic artificial heart in the first participant of the trial last August.

In November, the firm reported that the patient died due to reasons not related to the functioning of the prosthesis.

Carmat chief executive officer Stéphane Piat said: “It was with much grief that we learned of the death of the first patient enrolled in the pivotal study. We would like to extend our sincere gratitude to the patient and their family.

"Our motivation to provide an alternative for these patients facing total therapeutic stalemate is continuing to grow."

"We can confirm that the analyses that have been carried out have not shown the prosthesis to be involved in the patient’s death.

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"It functioned normally during the last three implantations, so our motivation to provide an alternative for these patients facing total therapeutic stalemate is continuing to grow.”

The approval is based on the outcome of the analyses and actions carried out by the firm with respect to ANSM’s regulations.

Carmat intends to expand the trial to other countries to comply with its clinical strategy for CE marking processes.

To meet the manufacturing requirements for the commercial launch of the prosthesis, the firm is set to open a new production site with automated processes, which is expected to be operational by the end of this year.

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