Further to last June’s announcement, the Carmat Biotechnology Company was granted authorisation on Tuesday, 24 November 2015 by the French medical authorities to perform a fourth artificial heart implant. The aim is to complete the initial trial phase : “By enrolling and following up a fourth patient for 30 days, Carmat is hoping to draw the feasibility study to a positive conclusion”.
The authorisation granted “follows on from the expert report submitted to the authorities by the company, proposing solutions that were implemented and validated to correct the anomaly observed [cause of death of first two patients]. The prostheses to be used in the next implants will incorporate these changes”. The group also specified that the “criterion linked to the heart failure stage has been relaxed to allow more patients to benefit” from a bioprosthetic heart.
Carmat is already looking ahead to the next trial phase, namely the “pivot study” phase which would involve up to twenty patients and allow the launch of medical devices on the European market.
FromANSM (Agence nationale de sécurité du médicament et des produits de santé – French National Agency of Medicines and Health Products Safety) and the EC (Ethics Committee).
The initial trial phase comprised four transplants: the first two patients died but the third patient who underwent transplant surgery last May is doing well, according to a Carmat press release (Cf. Gènéthique du 4 septembre 2015).
Sciences et Avenir (25/11/2015) – Le Figaro (25/11/2015)