The High Authority for Health and the National Medicines Safety Agency have issued the first authorizations for a new clinical trial of the artificial heart, as part of a program on medical innovations.
The green light for the return of clinical trials in France for the artificial heart seven years after the first attempts? According to decisions of the High Authority for Health (HAS) and the National Medical Safety Agency (ANSM), the Carmat device is eligible for a program called “Innovation package”. Its objective is to facilitate the study, then the commercialization of innovative medical devices.
Assess patient survival at 180 days
The French company Carmat has been developing an artificial heart for several years to treat people with end-stage biventricular heart failure. The system is capable of replacing the core entirely. Its validation by the HAS within the framework of the “Forfait innovation” is linked to several criteria, as explained by a press release from Carmat. The authority considers that “the Carmat heart meets the criteria for innovation thanks to the use of biological materials in contact with blood, its capacity for self-regulation and lighter and quieter external equipment”. The study proposed by Carmat will aim to assess patient survival 180 days after implantation. “We are delighted with this positive opinion from the HAS, which demonstrates a real need for more effective and safer care for patients suffering from heart failure in France”, welcomed the managing director of Carmat, Stéphane Piat. Before it is launched, the clinical trial project must be approved by a ethics committee. If so, he could be supported by the Ministry of Solidarity and Health.
In 2013, a patient had already been implanted in France, he died 75 days after the operation. The company had continued its trials, but they had all ended in the death of the people operated on. The ANSM then requested additional studies before authorizing the continuation of the trials.
Several tests abroad
In 2017, Carmat started clinical studies in other countries, notably in Kazakhstan. In February 2020, the artificial heart was authorized across the Atlantic: the Food and Drug Administration gave its approval for a “feasibility” clinical trial. Ten patients will undergo a heart transplant. The objective of the study is to assess their survival in the six months following the operation. Their recruitment should begin at the end of 2020. Until now, the artificial heart of the company Carmat has never been marketed, but only studied in the context of clinical work.
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