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 November 2018. The decisions were brought for twenty-two (22) medical devices.
Nine (9) decisions were released regarding prostheses:
- GYRACUP E - GYRACUP E ULTIMATE (without cement) / SYMBOL CUP DM HA - SYMBOL CUP DMR HA (without cement) / DS EVOLUTION DM HA - DS EVOLUTION DMR HA (without cement), double mobility cups consisting of an uncemented cupule combined with a conventional polyethylene insert (application for registration, approved)
- TREGOR MEDIAL CUP, dual mobility cup with a cemented cup and a conventional polyethylene insert (application for registration, approved)
- NOVAE TH & COPTOS TH (without cement), dual mobility cup with a cemented cup and a conventional polyethylene insert (application for registration, rejected because the available data do not establish the interest of NOVAE TH and COPTOS TH (without cement) in reconstruction with advanced bone destruction)
- SYMBOL CUP DM CEM (to cement) / GYRACUP E CEM (to cement) / DS EVOLUTION DM CEM (to cement), dual mobility cup with a cemented cup and a conventional polyethylene insert (application for registration, approved)
- PROFEMUR GLADIATOR (without cement), femoral stem with the modular neck (application for registration, accepted)
- PROFEMUR GLADIATOR (to be cemented), femoral stem with the modular neck (application for registration, accepted)
- PROFEMUR L, femoral stem with the modular neck (application for registration, accepted)
- CERAVER OSTEAL, centromedullary cement plug (cancelled)
- TMJ Prostheses, total prosthesis of the temporomandibular joint (renewal of registration, approved)
Five (5) decisions were released regarding cardiovascular devices:
- SYNERGY, a coronary stent coated with sirolimus (pharmacologically active product) (application for registration, approved)
- ULTIMASTER TANSEI, a coronary stent coated with sirolimus (pharmacologically active product) (application for registration, approved)
- PROMUS ELITE, a coronary stent coated with sirolimus (pharmacologically active product) (application for registration, approved)
- PROMUS PREMIER, a coronary stent coated with sirolimus (pharmacologically active product) (application for registration, approved)
- ACURATE NEO, transfemoral implanted aortic valve bioprosthesis (application for registration, approved)
Eight (8) decisions were released regarding other devices:
- SPIROTEL V2, portable electronic spirometer (renewal of registration, approved)
- ALOVA, memory foam mattress with shape memory (application for the amendment of the registration conditions, approved)
- SILK +, intracranial stent self-expanding controlled release (stent flow diverter), (application for registration, rejected because available data did not establish the interest of SILK + in the reasons claimed)
- HOT AXIOS, luminal biliopancreatic apposition implant and its delivery system with an electrocautery function system (application for the amendment of the registration conditions, approved)
- ARTISAN MRI for medullary neurostimulator of the PRECISION range, decahexapolar electrode for implantable medullary neurostimulation system (application for the amendment of the registration conditions, approved)
- LUTONIX 035 (model 9004), the paclitaxel-eluting balloon (application for registration, rejected because available data were insufficient to demonstrate the benefit of the paclitaxel-eluting balloon in patients with native arteriovenous fistula stenosis or restenosis up to 10 cm in length and 4 mm to 12 mm in diameter)
- CICA-CARE self-adhering silicone gel plate (application for registration, approved)
- INTELLIS, implantable and rechargeable medullary neurostimulator (application for registration, approved)
See the list of decisions in French here.
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