September 9, 2016 — Carmat announced that the first implantation of its bioprosthetic artificial heart within the framework of the PIVOTAL study has been carried out. The implantation was conducted in accordance with the authorizations obtained from the ANSM (French national agency for the safety of medicines and health products) and CPP (patient protection committee).
The clinical data collected during the PIVOTAL study will supplement the technical data of the CE marking dossier.
Carmat will publish information about the general progress made during the CE marking process.
In accordance with good clinical practice, the company reminds readers that it is not planning to publish specific information concerning the implantations of each patient involved in the study or their condition.
By pursuing the development of its total artificial heart, Carmat intends to overcome the well-known shortfall in heart transplants for the tens of thousands of people suffering from irreversible end-stage heart failure, the most seriously affected of the 20 million patients with this progressive disease in Europe and the United States.
For more information: www.carmatsa.com