The company that develops the artificial heart has denied wanting to settle abroad. She hopes to be able to resume testing quickly.
The Carmat company never wanted to leave France. The manufacturers of the artificial heart on Tuesday denied any intention of exile in the United States at a press conference on Tuesday, February 14. The leaders have in fact repeated that they wanted to continue their clinical trial in France and hoped for a rapid resumption of this work suspended since the death of the 5th patient implanted last October.
“I never said we were going to leave France,” said Stéphane Piat, director of Carmat, on the occasion of the presentation of the annual results of the French start-up. “We never talked about anything other than enrolling patients abroad,” he added.
Engaged in a standoff with the health authorities, the company would never have wanted to relocate its experiments abroad. Stéphane Piat, however, reiterated his call to the National Agency for the Safety of Medicines and Health Products (ANSM) for “more pragmatism on breakthrough innovation”.
Because for the latter, France’s problem is its lack of flexibility. In an interview given to Parisian last week, he explained in particular that the precautionary principle was out of date, adding that in “many countries we talk more about benefit / risk”.
Meeting at the Ministry of Health
But today, the speech is smoother. While the company is in discussion to resume the tests, the boss of Carmat praised the work of the ANSM which “makes difficult choices”, and felt that it was necessary to “respect” the rules of each. Remember that the ANSM refuses to relaunch artificial heart implantations until patient safety issues are resolved. A firm position which follows the death of the last patient linked to improper handling of the batteries.
The company also expects a lot from its meeting with the Ministry of Health which will take place “within 10 days”, according to the president of Carmat, Jean-Claude Cadudal. On this occasion, the promoter of the artificial heart should surely recall that this prosthesis offers a therapeutic alternative to patients suffering from terminal heart failure.
.