Today, the personal protection committee, the safety committee, as well as the regulatory authorities have issued a favorable opinion to resume recruitment of the following three patients in the feasibility trial.
Three other patients should indeed be operated in order to complete the first phase of the clinical trial, whose success will be evaluated in particular by the survival rate at one month or the conduct of the patient towards the transplant if he is in a condition of eligibility. , explained Carmat during the authorization to perform the implantation issued by the Medicines Safety Agency (ANSM) on September 24.
“The quality of the work of all the participants in the process of collecting and analyzing data from the first bioprosthesis implanted in humans made it possible to put in place additional measures to continue the trial under the best possible conditions of safety. »Declared Marcello Conviti, CEO of CARMAT in a press release.
The first implementation, a real success
The doctors concerned by this medical experience recalled the importance of the first lessons they were able to draw from this first clinical trial, concerning patient selection, postoperative follow-up, treatment and prevention of the difficulties encountered. “This is not a failure for the medical team who performed the transplant since they initially hoped for a survival period of 1 month. However, the patient has largely exceeded this period, living with the artificial heartfor nearly two and a half months ”recalls the Socité Carmat.
The heart of the Carmat company is a real hope for patients suffering from heart failure. This cardiovascular disorder makes it impossible for the heart to contract enough to send the volume of blood necessary to supply the whole body. People who suffer from it are constantly short of breath, tired and sometimes need to be hospitalized. In France, every year heart failureis responsible for more than 32,000 deaths.