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 June 2019.
Six (6) decisions were released regarding orthopedic devices:
- XLMOB (to be cemented), dual mobility acetabulum consisting of a cemented cup and a conventional polyethylene insert or a highly crosslinked polyethylene insert (application for registration, approved)
- CAPITOL - EVIDENCE (to cement), dual mobility acetabulum consisting of a cemented cup and a conventional polyethylene insert (application for registration, rejected)
- FIXA 3P DUPLEX (without cement), dual mobility acetabulum consisting of a cemented cup and a conventional polyethylene insert or a highly crosslinked polyethylene insert (application for registration, approved)
- CAPITOL - EVIDENCE (without cement), dual mobility acetabulum consisting of a cemented cup and a conventional polyethylene insert (application for registration, approved; rejected for all other types of CAPITOL – EVIDENCE)
- CAPTIV DM - EVIDENCE Ti / HAC, dual mobility acetabulum consisting of a cemented cup and a conventional polyethylene insert (application for registration, rejected)
- GALILEA (to cement), dual mobility acetabulum consisting of a cemented cup and a conventional polyethylene insert (application for registration, approved)
Eleven (11) decisions were released for cardiovascular devices:
- SURPASS, a self-expanding intracranial stent with controlled release said flow diverter (cancelled)
- AXS CATALYST, distal access catheter used in a thromboaspiration system (application for registration (Title V), approved)
- PIPELINE, a self-expanding intracranial stent with controlled release said flow diverter (cancelled)
- TREVO XP PROVUE, stent retriever (application for modification of the registration conditions (Title V), approved)
- OPTOWIRE DEUX, a guide for measuring the fraction of the coronary reserve flow (FFR; application for registration, approved)
- XIENCE XPEDITION, coronary stent coated with everolimus (pharmacologically active product) (application for modification of the registration conditions and renewal of registration, approved)
- XIENCE SIERRA, coronary stent coated with everolimus (pharmacologically active product) (application for modification of the registration conditions and renewal of registration, approved)
- JARVIK 2000 (ABDOMINAL VERSION) (JHI-002), intra-cardiac pump (cancelled)
- VALIANT NAVION, a thoracic aortic stent (application for registration, approved)
- POWERLINK and POWERLINK AFX, an abdominal aortic stent (cancelled)
- XIENCE ALPINE, coronary stent coated with everolimus (pharmacologically active product) (application for modification of the registration conditions and renewal of registration, approved)
Fifteen (15) decisions were released for other devices:
- NUCLEUS, cochlear implant systems composed of Nucleus Freedom Implant Contour Advance, Nucleus Freedom, Nucleus CI422, Nucleus CI512 and CP 910 and 920, KANSO (CP950) and NUCLEUS 7 (CP1000) sound processors (renewal of registration, approved)
- Cochlear Implant Systems: DIGISONIC SP, DIGISONIC SP EVO, NEURO ZTI CLA, NEURO ZTI EVO, Cochlear Implants - SAPHYR SP, SAPHYR CX, NEURO ONE, NEURO 2 Sound Processors (renewal of registration, approved)
- Cochlear Implant Systems: Mi1200 SYNCHRONY and Mi1200 SYNCHRONY PIN, Cochlear Implants - OPUS 2, RONDO, RONDO 2, SONNET, EAS SONNET Sound Processors (renewal of registration, approved)
- PIED RUSH KID PROTEOR, children’s play release foot (application for registration, approved)
- GLUCOFIX PREMIUM, a device for automatic reading of the blood glucose and ketonemia and GLUCOFIX b-KETONE SENSOR, associated test strips (renewal of registration, approved)
- 1025KS, high-speed concentrator for home oxygen therapy in a fixed position (application for registration, approved)
- SORBACT, compress (application for registration, rejected)
- Extension kits for the ACTIVA system (KINETRA AND SOLETRA), deep brain stimulation system (cancelled)
- SORBACT, wick (application for registration, rejected)
- SORBACT, dressing (application for registration, rejected)
- PROACT, periurethral adjustable sphincteric prosthesis for men (application for registration, approved)
- NEB 400 / NEB KIT, aerosol therapy nebulization system (application for registration, approved)
- NEB 200 / NEB KIT, aerosol therapy nebulization system (application for registration, approved)
- SYNCHROMED II - SYNCHROMED II: MyPTM remote control (TH90T02), programmable implantable pump with a variable flow (renewal of registration, approved)
- THEALOSE, sterile solution for ophthalmic use (application for modification of the registration conditions, approved)
See the list of decisions in French here.
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