CemarkingDubai Blog

CARMAT: Continuing Progress in Line with the Objective of Obtaining CE Marking in 2019

“We are ramping up our project on all of its strategic routes and are gradually meeting the key milestones that bring us closer each day to meeting our objective of obtaining a CE mark for the CARMAT total artificial heart in 2019. From a clinical perspective, we have carried out one third of the implantations foreseen within the framework of the PIVOTAL study. This sustained enrollment rate validates the pertinence of our international clinical strategy implemented in highly-specialized medical facilities. It also takes on its full meaning given the performances of the surgical teams, who have been able to substantially decrease the operating time, confirming that the implantation of the CARMAT heart is highly controlled and reproducible. These clinical breakthroughs are closely correlated to our industrial development and justify our decision to open a new manufacturing site in Bois-d’Arcy, near Paris. This new site will allow us to produce the prostheses necessary for the clinical trials and the subsequent commercial phase in compliance with certified procedures that meet the demands of industrial production. Lastly, as our project aims to address the issue of heart failure on a worldwide scale, we are delighted to see our discussions with the U.S. FDA progressing towards the initiation of an early feasibility study in the United States, a market with substantial potential for CARMAT”.

Acceleration in the pace of recruitment for the PIVOTAL study

The PIVOTAL study follows the feasibility study undertaken by CARMAT on 4 patients. It corresponds to the second phase of the clinical trials necessary to compile the CE marking clinical dossier. Within the framework of this study, CARMAT is planning to implant its bioprosthesis in approximately twenty patients with end-stage biventricular heart failure whose health state is more stable than that of the patients included in the feasibility study. This study’s endpoint is to show the survival of the implanted patients at 6 months and thus validate the CARMAT system’s safety, efficacy and performances.

CARMAT has received the essential regulatory authorizations to conduct this study in France and three other countries: Kazakhstan, the Czech Republic, and Denmark. This broadening of the study to include leading international facilities in the conduct of clinical trials on circulatory support devices targeting the European market has helped significantly accelerate patient enrollment in the study.

To date, the number of implantations already performed represents 30% of the study’s planned total.

The surgical procedure boasts a 100% success rate, and operating time has been cut by approximately 21% compared with the first implantations, showing both a substantial enhancement in surgical teams’ learning curve and good reproducibility of the surgery as the study progresses.

The patients treated in the PIVOTAL study have a more stable clinical profile than those involved in the feasibility study, as illustrated by the 100% survival rate at 1 month compared with 75% previously.

In order to further accelerate the implantation rate, CARMAT is planning to expand the network of investigation centers to 3 additional countries and is expecting to end PIVOTAL study implantations this year.

Major progress in the CE marking process

The CE marking procedure undertaken by CARMAT with certification body DEKRA aims to validate the CARMAT heart’s compliance with European regulatory needs. Within this framework, in 2017 CARMAT delivered more than half of the CE marking dossier’s modules, notably those concerning all the technical aspects. The Company is continuing to supplement the dossier with reliability data from prostheses operating constantly on test benches.

Following the PIVOTAL study, the clinical results will complete the final module of the CE marking dossier that will be submitted to DEKRA for validation, aiming to obtain CE marking in 2019.