The medical and entrepreneurial adventure continues, but how far? The Carmat company announced on Monday January 31 that it would not resume the implantations of its Aeson artificial heart before October, following having suspended them on December 2, 2021, due to health problems. “quality” encountered on two separate components of certain prostheses assembled at its site in Bois-d’Arcy (Yvelines) at the rate of sixteen per month.
“Corrective actions to avoid such defects have been defined, and are being integrated into production processes”, explained Carmat in a press release on Monday, January 31. They will take time. This work is scrutinized by Dekra, a certification body, but also by the National Agency for the Safety of Medicines and Health Products (ANSM) and the American Food and Drug Administration. Their green light is necessary for the resumption of implantations, both commercially and in the context of clinical trials.
At the end of 2020, the device designed from the 1990s onwards by cardiologist-surgeon Alain Carpentier had obtained European certification (“CE marking”) in the indication of “transplant bridge”, opening the way for it to be marketed in the twenty-seven countries of the Union. This autonomous and biventricular bioprosthesis, unique in the world, makes it possible to wait for an organ transplant, which is often impossible due to a lack of grafts, or to prolong the life of patients suffering from end-stage heart failure.
Positive feedback from doctors
The leaders of Carmat want to be calm on the medical level. The prosthesis does not present, according to them, any problem of design or biocompatibility; its difficulties are electronic (card) and mechanical (pump). They add that“In response to the continued interest of hospitals in Aeson, and encouraged by the positive feedback received from physicians who implanted its device, the company continues to train new centers, particularly in Germany, to enable a strong recovery of sales”.
Since its commercialization in July 2021, seven Aeson cores have been implanted: five in Germany and two in Italy. Several had been in trials, including the first in France at the end of 2013 (Georges-Pompidou European Hospital in Paris), then in the Netherlands, Denmark, Kazakhstan, the Czech Republic and finally in the United States. In France, five university hospital centers (CHU) have been selected (La Pitié-Salpêtrière, in Paris, Lyon, Lille, Toulouse and Rennes), as well as hospitals in Germany, which represent 40% of the European market for mechanical circulatory assist devices.
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