Restart of production and confirmation of the objective of resuming installations in October 2022
Following the characterization of the quality defects on the two components which were at the origin of incidents on some of its prostheses, CARMAT defined, in close collaboration with its suppliers, the corrective actions required.
These are now implemented in the production processes of the suppliers concerned, and include in particular reinforced controls.
Given the production times for prostheses both at its suppliers and at its factory in Bois-d’Arcy, CARMAT thus confirms that it will be able to have new implantable prostheses in October 2022.
At the same time, the company is continuing its dialogue with the notified body (DEKRA) and the competent authorities (ANSM in France and the Food & Drug Administration in the United States), whose authorization is necessary to resume operations.
These elements allow CARMAT to confirm its objective of resuming implantations in commercial and clinical settings in October 2022.
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