The French National Authority for Health (HAS) released new decisions about add-on and medical aid reimbursement of 28 medical devices from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in February.
Four decisions were released for cardiovascular devices:
- EDORA 8 DR-T, implantable cardiac pacemaker (renewal of registration, approved)
- EDORA 8 SR-T, implantable cardiac pacemaker (renewal of registration, approved)
- CARBOMEDICS CARBO-SEAL VALSALVA, aortic conduit with mechanical valve (application for registration, approved)
- CARBOMEDICS CARBO-SEAL, aortic conduit with mechanical valve (renewal of registration, approved)
Sixteen decisions were published for devices for arthroplasty:
- GYROS, double mobility cementless cup (application for registration, approved)
- FIXA 3P DUPLEX , dual-mobility cementless cup (application for registration, rejected due to insufficient expected benefit)
- FIXA DUPLEX, dual-mobility cemented cup (application for registration, rejected due to insufficient expected benefit)
- FIXA DUPLEX, dual-mobility cementless cup (application for registration, rejected due to insufficient expected benefit)
- LIBERTY SC - LIBERTY T, dual-mobility cementless cup (application for registration, approved)
- LIBERTY AC, dual-mobility cemented cup (application for registration, approved)
- ADES et ADES PLUS, dual-mobility cementless cup (application for registration, approved)
- ADES, dual-mobility cemented cup (application for registration, approved)
- INTEGRA DE REPRISE, dual-mobility cementless cup (application for registration, approved)
- INTEGRA, dual-mobility cementless cup (application for registration, rejected)
- QUATTRO CIM, dual-mobility cemented cup (application for registration, approved)
- QUATTRO HAP, dual-mobility cementless cup (application for registration, approved)
- TREGOR – TREGOR, dual-mobility cementless cup (application for registration, approved)
- TREGOR MEDIAL CUP, dual-mobility cemented cup (application for registration, approved)
- NOVAE, dual-mobility cementless cup (application for registration, approved for 28 mm diameter, rejected for 32 mm)
- NOVAE STICK, dual mobility cemented cup (application for registration, approved for 28 mm; rejected for 32 mm)
Two decisions were released for porous high-density polyethylene implants for facial and cranial reconstruction:
- OMNIPORE, (application for registration, rejected due to insufficient expected benefit)
- OMNIPORE (standard), (application for registration, rejected due to insufficient expected benefit)
Five decisions were for other devices:
- ALBER VIAPLUS V12, wheelchair add-on electric propulsion system (request for registration, approved)
- INVACARE COLIBRI OUTDOOR, modular electric scooter (application for registration, approved)
- LARYVOX FAHL, respiratory prostheses for total laryngectomy with or without phonatory implants (application for registration, approved)
- PONTO, osteo-integrated prosthesis (request for delisting, approved)
- RONDO 2, audio processor for cochlear implant system (application for registration, approved)
- RE-FLEX, prosthetic foot (III energy class) (renewal of registration, approved)
See list of decisions in French here.
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