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 French National Authority for Health (HAS) and the French national agency for medical safety (ANSM), the Carmat device is eligible for a program called “Innovation package”. Its objective is to facilitate the study and then the marketing of innovative medical devices.
Assess patient survival at 180 days
The French company Carmat has been developing for several years a artificial heart to treat people with end-stage biventricular heart failure. The system is able to completely replace the heart. Its validation by the HAS as part of the “Innovation Package” is linked to several criteria, as explained in a Carmat press release. The authority considers that “the Carmat heart meets the criteria of innovation through the use of biological materials in contact with the blood, its self-regulating capacity and the lighter and quieter external equipment”. The study proposed by Carmat will aim to assess the survival of patients 180 days after implantation. “We are delighted with this positive opinion of the HAS which demonstrates a real need for a more efficient and safer care for patients suffering from heart failure in France “, welcomed Carmat’s general manager, Stéphane Piat. Before it was launched, the project clinical trial must be approved by a ethics committee. If so, it could be taken care of 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 tests, but they had all ended in the death of operated persons. 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 agreement for a “feasibility” clinical trial. Ten patients will undergo a heart transplant. The objective of the study is to assess their survival within six months of the operation. Their recruitment should start at the end of 2020. So far, the artificial heart of the Carmat company has never been marketed, but only studied in the context of clinical work.
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