The Carmat company, designer of the total artificial heart project aimed at offering patients a therapeutic alternative suffering from heart failure terminal bi-ventricular, announced a new implantation of its artificial bio-prosthetic heart, this time in the Czech Republic.
The operation took place within the framework of the PIVOT study approved by the National Agency for the Safety of Medicines and Health Products (ANSM).
A study involving 20 patients
Last October, the Carmat company announced that it had successfully carried out the first transplant of his artificial heart abroad. The operation had been carried out in Kazakhstan, at an undisclosed date.
The internationalization strategy of the PIVOT study is based on a network of centers specializing in the conduct of clinical trials of cardiac devices intended for the European market. It also aims to accelerate the recruitment of patients, in line with the schedule which is expected to be finalized by the end of 2018. By then, the study should include a total of twenty patients suffering heart failure
advanced bi-ventricular.
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