Transcatheter aortic valve implantation (TAVI) devices– Clinical data requirements
TAVI devices are listed by brand name in Section III of the list of products and services qualifying for reimbursement in France (LPPR list). This inclusion procedure involves the submission of a medico-technical file to the National Committee for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS) for assessment of their expected or actual clinical benefit with a view to funding by the French national health insurance system.
In addition, the CNEDiMTS must “specify the procedures and principles it uses to apply assessment criteria for health products with a view to their funding by the French national health insurance system” (art. L 161-37 of the French Social Security Code).
The purpose of this document is therefore to explain the requirements of the CNEDiMTS in terms of the minimal clinical data to be supplied in France for:
a new TAVI device;
the acceptance of a new indication for a TAVI device already listed in the LPPR list;
the renewal of inclusion of a TAVI device in the LPPR list.