The French National Authority for Health (HAS) released new decisions about add-on and medical aid reimbursement of many medical devices from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in October 2018.
Seven (7) decisions were released for prostheses:
- ODRA, custom-made, articulated, dynamic orthosis using ODRA (Distraction Orthotic and Rotation for Osteoarthritis) (renewal of registration, approved)
- LEGION OXINIUM, biocondylar femoral implant, cemented, made of zirconium oxide (application for registration, rejected because the data does not demonstrate interest for it)
- RHEO KNEE (3rd generation), monoaxial knee, microprocessor-controlled joint and magnetorheological fluid (application for registration, approved)
- PINNACLE ULTAMET, femoral head metal for a total hip prosthesis (cancelled)
- AMOENA, external silicone breast prosthesis, the standard model (application for the amendment of the registration conditions, approved)
- NATRELLE 168 / NATRELLE 468, breast implants (cancelled)
- RL, femoral stem with the modular neck (without cement) (application for registration, rejected because the data does not demonstrate interest for it)
Three (3) decisions were released for cardiovascular devices:
- CARBONART AVP-BOVIN, aortic duct with a mechanical valve (cancelled)
- COREVALVE EVOLUT R, aortic valve bioprosthesis implanted by the transcutaneous arterial route (application for registration, approved)
- COREVALVE EVOLUT PRO, aortic valve bioprosthesis implanted by the transcutaneous arterial route (application for registration, approved)
Eleven (11) decisions were released for other devices:
- URGOCLEAN, compress and wick (renewal of registration, approved)
- NEUROCYBERNETIC PROTHESIS (NCP) SYSTEMS 102 & 102R, Neuro-Cybernetic Prothesis Left Wave Nerve Stimulator (NCP) and Bipolar VNS Electrode (cancelled)
- PHOENIX, viro-inactivated bone allograft, (application for the amendment of the registration conditions, approved)
- EDEN, lubricated male condom (application for registration, approved)
- SENTRY 1200, category 3 support mattress for the prevention of pressure pain with automatic, constant pressure and / or dynamic air pressure over 15 cm of air thickness (cancelled)
- PROVOX LUNA, a respiratory prosthesis for total laryngectomees with or without phonatory implant (application for registration, rejected)
- KIT BIFLEX, multitype compression system (application for registration, approved)
- NEOVIS TOTAL multi, sterile emulsion for topical ophthalmic use (application for registration, approved)
- NEOVIS TOTAL, sterile emulsion for topical ophthalmic use (application for registration, approved)
- HYLOVIS LIPO, sterile emulsion for topical ophthalmic use (application for registration, approved)
- HYLOVIS LIPO MULTI, sterile emulsion for topical ophthalmic use (application for registration, approved)
See the list of decisions in French here.
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