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France

12
Apr 2019

Innovation funding of WISE cardiac resynchronization therapy technology in France

On the 16th of February of 2019, the approval for financing of WISE CRT system in a framework of “forfait innovation” program was released in the Official French Gazette. This financing is provided for the 48-months period; it includes the amount of €25,600 and cannot be combined with other benefits. It is fully covered by the compulsory health insurance schemes.
20
Feb 2019

Data requirements for TAVI registration updated in France

On January 31st, 2019, the French High Authority for Health (HAS) has published a new assessment of transcatheter aortic valve implantation (TAVI). The objective of this assessment was to clarify the level of requirements of the National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in terms of minimal clinical data to provide for the registration of a new TAVI on the LPPR, for the acceptance of a new indication for a TAVI already registered on the LPPR and for renewal of registration of a TAVI registered on the LPPR.