After the death of the 5th patient and the threats of exile in the United States, the Carmat company should be received soon by the Ministry of Health.
Did the threats of departure from the French company Carmat have the desired effect? The Ministry of Health is in any case ready to listen to the manufacturer of the artificial heart. Stéphane Piat, director general of Carmat, should be received soon by the ministerial delegate for innovation, according to the Parisian.
During this meeting, the promoter of the artificial heart should recall that this prosthesis offers a therapeutic alternative to patients suffering from terminal heart failure. A device that has exceeded its promises with four patients implanted. All died but the prosthesis had been ruled out for three of them. The second patient implanted in August 2014 even survived more than 9 months. Encouraging results which had enabled the company to move on to the second stage of its clinical trial, the PIVOT study.
A phase that lasted barely a month and a half. The 5th patient implanted at the end of August 2016 died in October following a “bad handling of the batteries by the patient which caused the stopping of the prosthesis”, we learned this Tuesday, February 7th. However, one of the objectives of this trial was survival greater than 180 days.
A trial suspended since October
The fact remains that since this death, the trial which was to include about twenty patients before 2018 has been suspended. Too long an interruption for the boss of Carmat. At the beginning of the week, Stéphane Piat did not rule out the possibility of going to the United States to be able to continue the research. “The National Medicines Safety Agency (ANSM) observes the precautionary principle. But this principle is outdated in many countries where we talk more about benefit / risk “, he explained, adding that the Americans” are more flexible and more pragmatic “.
For its part, the ANSM refuses to relaunch the study until the safety issues for patients are resolved. But it appears that the agency is very demanding. Carmat would not yet be able to satisfy them “within the allotted time”, which would explain why the company itself withdrew its request last December. It plans to submit a new request for resumption of trials when it has been able to collect all the elements guaranteeing patient safety.
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