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 the first half of November:
- Five decisions were released for orthopedics devices:
-
- TWIN CUP CEMENTED, double-mobility acetabular cup (application for registration, rejected due to insufficient expected benefit (AS))
- XLMOB CEMENTED, double-mobility cemented cup (application for registration, rejected due to insufficient expected benefit (AS))
- XLMOB NON CIMENTED, double-mobility non-cemented cup (application for registration, rejected due to insufficient expected benefit (AS))
- SATURNE II (without cement), double-mobility non-cemented cup (application for registration, approved)
- AIR, meniscal repair system (application for registration, approved)
- Two decisions were published for drug-coated balloons for peripheral vascular disease:
-
- LUTONIX 035, drug-coated balloon (application for registration, approved)
- RANGER, drug-coated balloon (application for registration, approved)
- Two decisions concern devices for radiofrequency ablation procedure:
-
- EVAC (COBLATION SYSTEM), radiofrequency electrodes for tonsillectomy (application for registration, approved)
- PROCIZE EZ VIEW (COBLATION SYSTEM) , radiofrequency electrodes ablation for tonsillectomy (application for registration, approved)
- Four decisions consider other devices:
-
- LIFECHOICE ACTIVOX 4L, portable oxygen concentrator (application for registration, approved)
- URGO K2, two-layer bandage system for venous compression (request for renewal of registration, approved)
- URGO K2 Latex Free, two-layer bandage system for venous compression (request for renewal of registration, approved)
- ALLEVYN GENTLE BORDER HEEL, hydrocellular dressings (anatomical shape heel) (application for registration, approved)
See list of decisions in French here.
Subscribe to our newsletter delivered every second week not to miss important reimbursement information.