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 the period July-September 2018.
Sixteen (16) decisions were released for prostheses:
- NAOS (without cement), femoral stem (application for registration, because the data does not demonstrate interest for it)
- ATHELIA II (with cement), dual mobility cotyle consisting of a cemented cup and a conventional polyethylene insert (application for registration, approved)
- ATHELIA (without cement), dual mobility cotyle consisting of a cemented cup and a conventional polyethylene insert (application for registration, approved)
- BI-MOBILE LINK (with cement), dual mobility cotyle consisting of a cemented cup and a conventional polyethylene insert (application for registration, rejected because the data does not demonstrate interest for it)
- BI-MOBILE LINK (without cement), dual mobility cotyle consisting of a cemented cup and a conventional polyethylene insert (application for registration, rejected because the data does not demonstrate interest for it)
- ATLANTIS Modular (without cement), femoral stem with modular collar (application for registration, approved)
- BLUEPRO, advancement mandibular orthosis (application for registration, approved)
- XO (without cement), modular collar (application for registration, approved)
- XO (with cement), modular collar (application for registration, approved)
- LOUXOR, modular collar (application for registration, approved)
- H MAX M, hip prosthesis (element) – femoral stem (application for registration, approved)
- SAM-FIT, hip prosthesis (element) – femoral stem (application for registration, rejected because the data does not demonstrate interest for it)
- MINIMA M, hip prosthesis (element) – femoral stem (application for registration, rejected because the data does not demonstrate interest for it)
- HARMONY (reference 4R146), controlled depressurization suspension system of the lower limb prosthesis (first cancelled; the amendment of the registration conditions and the renewal of registration approved later)
- ECOFIT 2M and 2M SP, dual mobility acetabulum consisting of a no-cement cup and a conventional polyethylene insert (PEHR) (application for registration, rejected because the data does not demonstrate interest for it)
- ECOFIT 2M (with cement), dual mobility acetabulum consisting of a no-cement cup and a conventional polyethylene insert (PEHR) (application for registration, rejected because the data does not demonstrate interest for it)
Eighteen (18) decisions were released for cardiovascular devices:
- OPEN PIVOT, aortic duct with mechanical valve (application for registration, approved)
- PRO KINETIC ENERGY, coronary stent coated with silicon carbide (product without pharmacological action) (renewal of registration, approved)
- iSTENT Inject, trabecular microstrain stent (application for registration, approved)
- CAVGJ 514 00, aortic duct with mechanical valve (renewal of registration, approved)
- VAVGJ 515, (renewal of registration, approved)
- RESOLUTE ONYX, coronary stent coated with zotarolimus (pharmacologically active product) (application for the amendment of the registration conditions, rejected)
- IMPELLA 5.0, percutaneous electrical mechanical assistance device (left monoventricular, short duration) (application for registration - Title V, rejected)
- IMPELLA CP, percutaneous electrical mechanical assistance device (left monoventricular, short duration) (application for registration - Title V, rejected)
- ZENITH BRANCH, aortic stent (application for the amendment of the registration conditions and the renewal of registration, approved)
- COREVALVE EVOLUT R, aortic valve bioprosthesis implanted by the transcutaneous arterial route (application for the amendment of the registration conditions, approved)
- COREVALVE EVOLUT PRO, aortic valve bioprosthesis implanted by the transcutaneous arterial route (application for registration, approved)
- COREVALVE AOA, aortic valve bioprosthesis implanted by the transcutaneous arterial route (application for the amendment of the registration conditions, approved)
- COREVALVE EVOLUT AOA, aortic valve bioprosthesis implanted by the transcutaneous arterial route (application for the amendment of the registration conditions, approved)
- CONFORMABLE TAG, thoracic aortic stent (application for the amendment of the registration conditions, approved)
- MITRACLIP NTR, mitral ‘edge-to-edge’ repair clip (application for registration, approved)
- MITRACLIP XTR, mitral ‘edge-to-edge’ repair clip (application for registration, approved)
- SOLITAIRE 2, stent retriever (application for the amendment of the registration conditions, approved)
- SOLITAIRE PLATINUM, stent retriever (application for the amendment of the registration conditions, approved)
Eighteen (18) decisions were released for other devices:
- INVACARE COLIBRI OUTDOOR, modular electric scooter (application for registration, approved)
- BAHA, osseointegrated hearing aid (cancelled in July, renewal of registration approved in August)
- INFINITY, non-rechargeable system for deep brain stimulation (application for the amendment of the registration conditions, approved)
- PRECISION MRI ASSEMBLY associated with the INFINION CX electrode, implantable and rechargeable medullary neurostimulation system (application for the amendment of the registration conditions, approved)
- PRECISION NOVI associated with the INFINION CX electrode, implantable and non-rechargeable system of spinal neurostimulation (application for the amendment of the registration conditions, approved)
- PRECISION SPECTRA associated with the INFINION CX electrode, implantable and rechargeable medullary neurostimulation system (application for the amendment of the registration conditions, approved)
- COMET ALPINE +, modular electric scooter (application for registration, approved)
- Ultrafill, system for home oxygen therapy with ambulation (application for the amendment of the registration conditions, approved)
- GLACE, non-absorbable bone substitute (application for registration, approved)
- BIOSEM II, centre-medullary cement shutter (renewal of registration, approved)
- URGOSTART Interface, bandage (application for the amendment of the registration conditions and the renewal of registration, approved)
- URGOSTART, bandage (application for the amendment of the registration conditions and the renewal of registration, approved)
- URGOSTART Plus Compress, bandage (application for registration, approved)
- URGOSTART Plus Border, bandage (application for registration, approved)
- URGOSTART Border, bandage (application for the amendment of the registration conditions and the renewal of registration, approved)
- ALBER E-MOTION M25, power assisted electric propulsion device for manual wheelchairs (application for registration, approved)
- SOLEUS, class III energy recovery foot (application for registration, approved)
- MINIMED 2007D, implantable pump system for intraperitoneal insulin delivery (renewal of registration, approved)
See list of decisions in French here.
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