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Carmat announced that it decided to withdraw its initial request to resume the pivotal study on the company's artificial heart. Last November, French regulator ANSM requested Carmat to suspend further artificial heart implants following the death of a fifth patient in October, after being implanted with the device at the end of August 2016.
During discussions with the ANSM regarding the trial's resumption, "it became clear that the requested scope of analysis was broader that that undertaken by the company," Carmat said, adding that "given the nature of the remaining issues," the company is "not in a position to meet the requirements within the stated timeframe." Carmat added that it intends on "filing a new request in the near future" with the required items, adding that the pivotal study carried out in France "will remain suspended until ANSM accepts this new application."
Meanwhile, Carmat said it is "important to provide details regarding the patient's death in order to rectify certain information" published in the press. The company explained that "the patient's death was due to an interruption in the power supply system, following an incorrect battery handling by the patient, as a result of which the prosthesis stopped functioning." Carmat added that it is "working on this aspect relating to post-operative monitoring in order to increase safety for the next patients."
Carmat's shares fell as much as 5.3 percent after Le Parisien published an interview with CEO Stéphane Piat in which he expressed frustration about the trial. However, Piat remarked that "the prosthesis functioned normally during the last three implants, thus strengthening our incentive to provide a suitable response for patients facing total therapeutic stalemate." Piat added "the results provided by the self-regulating system used during the last implant have been very encouraging."
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