The French company,Carmat, has just announced the first successful heart transplant in a patient previously implanted with a Carmat artificial heart, in its Pivot study.
The patient received the Carmat artificial heart in October 2017 and “after 8 months of excellent support provided by the total artificial heart”, underwent donor heart transplant surgery to replace the prosthesis. The surgery was performed in Kazakhstan, at the National Center for Cardiac Surgery in Astana, by a team led by Dr. Yuriy Pya, CEO of this hospital centre.
The patient, who was suffering from terminal heart failure, was initially unlikely to be selected for a heart transplant because of his pulmonary hypertension. In the eight months following implantation of the artificial heart, the patient’s health “improved considerably thanks to the support of the Carmat device”. His pulmonary hypertension stabilised and donor heart transplant surgery was performed in June. Doctor Pya explained that he had “observed (…) an improvement in the pulmonary hypertension “diagnosed in the patient fitted with the Carmat prosthesis “based on the continuous data provided” by the device.
Launched in France in the summer of 2016, the Pivot trial was delayed due to the death of the first patient to undergo artificial heart implantation in this study. According to the company, the death was linked to the incorrect handling of the device batteries by the patient in question. Following this death, the Autorité Nationale de Sécurité du Médicament (ANSM – French National Authority for the Safety of Medicines and Health Products) demanded the suspension of the Pivotstudy. During this period, Carmat made improvements to the device.
The pivot study was resumed in October 2017. By this time, Carmat had also extended its device implantation sites to Kazakhstan, the Czech Republic and Denmark. The primary aim of the study was “broadly reached” in this case since it stipulated a survival rate of 180 days (6 months) for the transplanted patient.
The company announced that new implantation centres would “soon” be authorised in other countries in order to maintain a “sustained” rate of implantations.
It also hopes to obtain CE marking (authorisation for marketing in Europe) for its prosthesis in 2019.
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