Following the death of the fifth transplant patient, the French National Agency for Medicines and Health Products’ Safety (ANSM) instructed the Carmat Company to suspend clinical trials involving its artificial heart (see Death of fifth patient transplanted with a Carmat heart: implantations suspended). The Company had attributed this death to “poor patient handling of the batteries, causing the prosthesis to arrest”, but ANSM asked for more information and additional guarantees.
Yesterday, the Carmat Company announced that “following in-depth evaluation, ANSM considered that Carmat had provided sufficient evidence to allow the trial to resume under safe conditions with satisfactory risk management”. The Medicines Agency has nevertheless called for the Company to be “particularly vigilant in terms of patient safety, the quality of the data provided and the analysis carried out”. It has also asked for “an interim overall analysis of the next five patients enrolled (in this clinical trial)”.
This decision should allow the Carmat Company to resume the clinical trials which have to include between 15 and 20 patients presenting with particularly severe heart failure and warranting a heart transplant. Eventually, the aim is for the prosthetic heart to offset “the shortage of transplant organs available for subjects with terminal heart failure”.
The Carmat Company is also pursuing its approach to “extend the clinical trial to other countries in addition to France”. And it is considering “filing a request for CE marking by the end of 2018. This step is essential in order for the Company to market its device in the European Union” (see Carmat Heart: a step towards its market launch and the artificial heart “market” is soaring).
Le Figaro, Christophe Archambault (02/05/2017)