The French National Authority for Health (HAS) published a new set of decisions in relation to add-on reimbursement of medical devices and reimbursement of medical aids that had been released by National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in October:
- Six decisions for orthopedics devices:
- ULTRAFILL, home oxygen system (request for renewal of registration, approved)
- FLEX-FOOT BALANCE, prosthesis of multi-axial foot (request for renewal of registration, approved)
- FLEX-FOOT ASSURE, prosthesis of heel combined with the full-length keel (application for registration, approved)
- OSTIBONE, injectable synthetic bone graft substitute (request for renewal of registration, approved)
- MULTIFLEX, prosthetic foot mounted on a multiaxial ankle (request for renewal of registration, approved)
- DYNACITY 1A510, prosthetic foot class II energy (application for registration, approved)
- Two decisions for heart valve replacement procedures:
- SAPIEN 3 Model 9600 TFX transapical, bioprosthetic aortic heart valve transapical (request for extension of condition for reimbursement, request for raise of ASA level, rejected)
- SAPIEN 3 Model 9600 TFX transfemoral, bioprosthetic aortic heart valve transfemoral (request for extension of condition for reimbursement – approved; request for raise of ASA level - rejected)
- Two decisions about devices for peripheral vascular disease and ischemic stroke:
- LUTONIX 035, drug coated balloon (administrative amendment)
- TREVO XP PROVUE, stent retriever (administrative amendment)
- Three decisions for other devices:
- ONYX LES, liquid embolic system (request for amendment, approved)
- LATITUDE NXT, remote monitoring system (request for amendment, approved)
- ASKINA CARBOSORB, sterile wound dressing with activated charcoal cloth layer (request for renewal of registration, approved)
- ULTRAFILL, home oxygen system (request for renewal of registration, approved)
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