MAINTENANCE – Carmat can resume testing of his artificial heart. Its general manager details the improvements made and the next steps.
After the death last October of the fifth patient who received the Carmat artificial heart, only a month and a half after its implantation, the French biotechnology group had suspended its clinical trial, at the request of the National Medicines Safety Agency (ANSM) .
The latter has, this Tuesday, authorized Carmat to take it back. “After an in-depth assessment, the ANSM considers that the Carmat company has provided information allowing the trial to be resumed under satisfactory conditions of safety and risk control”, could one read on the website of the health agency. , which allows itself, however, an interim analysis “relating to the next five patients”.
Stéphane Piat, CEO of Carmat since September 2016, returns to Why actor on the adaptations of the protocols, and on the steps which will lead, he hopes, to the commercialization of the artificial heart in 2019.
What made the ANSM change its mind?
Stéphane Piat: The strategy has not changed, but the more successful protocols that we presented to the ANSM convinced her. Event or not, we are always in a process of continuous improvement. The actions that followed the voluntary suspension of the study were accompanied by a strengthening of the post-operative protocol, and we are committed to working on improvements to the battery system, insofar as they will not increase the risks. of the device.
Who are the candidates who will be included in the study?
Stéphane Piat: We are not yet in the logic of being an alternative to a heart transplant. Candidates are patients either who no longer have time to wait for a transplant, or who do not have the opportunity to receive it.
We reached an agreement with Dekra (the certification body associated with the project, editor’s note) to have a stepwise approach. The number of patients will therefore depend on the quality and consistency of the results. If the trend is positive, we will undoubtedly need a smaller number of patients, but we expect between ten and twenty patients.
Are other countries affected?
Stéphane Piat: Opening up to other countries is part of the logic of any development of therapy, medical device or pharmaceutical research. Carmat, which was a Franco-French initiative, was initially limited to France. But the desire to involve other countries was present from the start of development. We did not anticipate this opening, nor did we delay it. We believe now is the right time to start expanding the study to foreign countries.
How quickly do you plan to take over the facilities?
Stéphane Piat: Our strategy is based on finding patients who best respond to our therapy. We focus on their selection, which means that we are not necessarily going to treat patients in a trickle, as we have done in the past, but rather work to find those who will respond best to our therapy. . We may not start immediately, in the coming days, but treat several patients, over a shorter period of time.
Will the suspension of the trials have consequences for the marketing?
Stéphane Piat: As we said at the General Assembly last week, we are sticking to the agenda. In the reference document that we communicated to Dekra, we committed to completing the clinical module at the end of 2018. The follow-up should last approximately six months, which means that we will end the trial in June. 2018. Then, from the moment the file is submitted to Dekra, its processing should not take more than a few months, even if it is complex and particular.
We believe we can meet the deadlines that correspond to the treatment of this fifteen patients by June of next year. This represents more than one patient per month, which, given the needs and the willingness to participate of the medical centers, seems to be something achievable.
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