It had raised considerable hope for many patients with severe heart failure. The Carmat artificial heart clinical trial is now suspended after the death of the fifth patient in October. Three and a half months later, the company of the same name is considering continuing its study outside French soil. Asked by The Parisian, its managing director, Stéphane Piat, believes that France does not offer good conditions for innovation. The demands of the French authorities prompted the company to withdraw its request for authorization to continue the research in December.
For Stéphane Piat, the National Agency for the Safety of Medicines and Health Products (ANSM) requests “too many documents […] in relation to the problem identified. The death of the patient has nothing to do with the Carmat heart. If the authorities’ expectation is zero risk, many will be disappointed, in the first place the patients who are waiting to be implanted ”. The managing director admits that certain precautions are necessary but prefers the principle of benefits / risks in force in other countries to the French precautionary principle.
Resume testing abroad?
Does society mean by this that it will look elsewhere to develop and test its artificial heart? The answer is not clear: “we will work with people capable of understanding our problem. We are at a point in the study where we have to go quickly to progress ”. Carmat has so far met with the American health authority (Food and Drug Administration), but nothing has been set in motion.
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