Paris, February 6, 2017 (8:45 pm CET)
CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart project, aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, today provides an update on the suspension of the Pivotal study on its artificial heart.
As indicated in the press release of November 30, 2016, the Company confirmed that the prosthesis functioned correctly during its use by the 1st patient in the PIVOTAL study. However, CARMAT feels important to provide details regarding the patient’s death in order to rectify certain information published in today’s press. Indeed, 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’s Support-Training teams are actively working on this aspect relating to post-operative monitoring in order to increase safety for the next patients.
During the various discussions held with the ANSM regarding the resumption of the trial, it became clear that the requested scope of analysis was broader that that undertaken by the Company. Given the nature of the remaining issues, CARMAT was not in a position to meet the requirements within the stated timeframe. In order to give itself the necessary time to provide the elements required for the most comprehensive answer possible, the Company has decided to withdraw its initial request to resume the trial, in compliance with established procedures with the intention of filing a new request in the near future with the required items. The PIVOTAL study carried out in France will remain suspended until ANSM accepts this new application.
“The prosthesis functioned normally during the last three implants, thus strengthening our incentive to provide a suitable response for patients facing total therapeutic stalemate. Our confidence is further enhanced by the fact that the results provided by the self-regulating system used during the last implant have been very encouraging”, says Stéphane Piat, CEO of CARMAT.
