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Our Vision

Carmat

Our Vision

Become the primary alternative to heart transplants with the implementation of our Total Artificial Heart.

Our  Mission

Carmat will provide cardiologists with innovative technologies that save lives and improve the quality of life for patients with advanced heart failure.

Our History

2021

  • 19/07/2021

    First commercial implant of Aeson® artificial heart in Europe. This implant was performed by the team headed bu heart surgeon DR. Ciro Maiello at the Azienda Ospedaliera dei Colli hospital in Naples, Italy.

  • 15/07/2021

    First human implant of Aeson® total artificial heart in the United States within the framework of the Early Feasibility Study (EFS). In accordance with the study protocol approved by the FDA, 10 transplant-eligible patients are expected to be enrolled in this trial. The primary study endpoint is patient survival at 180 days post-implant or a successful cardiac transplantation within 180 days post-implant. It is a staged study with a progress report of the first 3 patients after 60 days, before the enrollment of the next 7 patients.

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.

Governance

Carmat governance ensures an effective and transparent organization for its different supervisory and operational management teams to create long-term value for all stakeholders. It includes the Management Team and the Board of Directors.

Code of ethics and business conduct

Download the Code of ethics and business conduct of Carmat

French gender Equality Index

Carmat SA scores a total of 96 points for the year 2020.

For more informations, download the french gender equality index of Carmat.

Location

Carmat

Corporate Headquarters 

Immeuble l’Etendard, 36 avenue de l’Europe, 78140 Vélizy-Villacoublay, FRANCE

Manufacturing Site 

9 rue René Clair, 78390 Bois-d’Arcy, FRANCE

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