2020

22/12/2020
On December 22, 2020, CE marking obtained for the bridge to transplant (BTT) indication.
12/10/2020

The French National Authority for Health (HAS) confirmed its positive opinion regarding the financing by special exemption of the CARMAT total artificial heart within the framework of the EFICAS study, a prospective, multicenter, non-randomized study to be undertaken on 52 patients in France. Carmat has been granted €13 million in funding by the French Ministry of Health and Solidarity to conduct the EFICAS clinical study.
06/08/2020

Bridge to transplant experience published in the Journal of Heart and Lung Transplantation.
05/02/2020

Carmat received full approval from the FDA (Food & Drug Administration) to undertake a clinical feasibility study in the United States on 10 patients eligible for a transplant. The Centers for Medicare & Medicaid Services (CMS) approved coverage of the Carmat device and routine care items and services supplied to patients within the framework of this study.

2019

31/12/2019

Full transfer of production to the New manufacturing site in Bois d’Arcy, France.

2018

11/07/2018

Finalization, with positive results, of the first part (cohort 1 of 10 patients) of the pivotal study. Beginning of implantations for cohort 2.

2017

31/12/2017

Applying for CE marking and commercial authorization. The CE mark is a prerequisite to market the prosthesis in Europe. It entails conformity with the EU regulations regarding design, manufacturing and clinical evaluation. The objective of the pivotal study is to demonstrate safety and performance of the Carmat TAH.

2016

31/12/2016

With the feasibility study relating to four patients completed, the experience gained allows Carmat to start the pivotal study, after receiving both ANSM (National agency for medicines and health product’s Safety) and CPP authorizations.

2013

31/12/2013

Carmat obtains authorization from the ANSM to conduct a feasibility study in France involving four patients. First successful implantation performed on December 18, 2013 at the Georges Pompidou European Hospital by Professor Christian Latrémouille.

2011

31/12/2011

Carmat presents preclinical hemocompatibility data to the 25th Annual Congress of the European Association for Cardio-Thoracic Surgery (EACTS). Carmat received approval from the CPP from the French ethical research committee.

2008

31/12/2008

Creation of CARMAT by Matra Défense (Airbus Group), Truffle Capital and Professor Alain Carpentier.

CARMAT anticipates implants of its Aeson artificial heart to resume in October 2022

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