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 February 2019.
Thirteen (13) decisions were released regarding orthopedic devices:
- COLLAPAT II, bone substitute derived from bovine derivatives (renewal of registration, approved)
- STRATOS (without cement), dual mobility acetabulum consisting of an uncemented cup and a conventional polyethylene insert (application for registration, approved)
- DOUBLE MOBILITY COTYL CEMENT (with cement), dual mobility acetabulum consisting of an uncemented cup and a conventional polyethylene insert (application for registration, approved)
- COTYLE DOUBLE MOBILITY HAC (without cement), dual mobility acetabulum consisting of an uncemented cup and a conventional polyethylene insert (application for registration, approved)
- REBEL RELIEVER, dynamic articulated knee brace (application for registration, approved)
- MOBIDERM (custom made), limb compression device (application for registration, rejected because the provided data do not demonstrate the interest)
- MOBIDERM (auto-fit), limb compression device (application for registration, rejected because the provided data do not demonstrate the interest)
- CUSTOMBONE, customized bone substitute in porous calcium hydroxyapatite for cranial vault reconstruction (renewal of registration, approved)
- DIZG, viro-inactivated bone graft allograft by DIZG method (application for registration, approved)
- MPACT DM, dual mobility acetabulum consisting of an uncemented cup and a conventional polyethylene insert (application for registration, approved)
- VERSAFITCUP DM, dual mobility acetabulum consisting of an uncemented cup and a conventional polyethylene insert (application for registration, approved)
- VERSACEM, dual mobility acetabulum consisting of an uncemented cup and a conventional polyethylene insert (application for registration, approved)
- ULTRA FAST-FIX, meniscal anchor, resorbable and non-absorbable (renewal of registration, approved)
Nine (9) decisions were released for cardiovascular devices:
- ELUNA 8 (SR-T and HF-T), pacemaker with home monitoring system (cancelled)
- ENDURANT II associated with the HELI-FX EndoAnchor Fixation System, abdominal aortic stent (application for registration, rejected because the provided data do not demonstrate the interest)
- ENDURANT IIs associated with the HELI-FX EndoAnchor Fixation System, abdominal aortic stent (application for registration, rejected because the provided data do not demonstrate the interest)
- RELAY PRO, thoracic aortic stent (application for registration, approved)
- RELAY NBS PRO, thoracic aortic stent (application for registration, approved)
- LVIS, self-expanding intracranial stent (application for the amendment of the registration conditions, approved)
- GORE VIABAHN with bioactive coating PROPATEN, self-expanding covered stent with an inner surface coated with porcine heparin (application for registration, approved)
- ELUNIR, coronary stent coated with ridaforolimus (pharmacologically active product) (application for registration, approved)
- YUKON CHROME PC, coronary stent coated with sirolimus (application for registration, approved)
Ten (10) decisions were released for other devices:
- SMARTDRIVE MX2+, electric propulsion and power assisted propulsion device for manual wheelchairs (application for registration, approved)
- WEB, aneurysm embolization system (application for registration, approved)
- NUTRAMIGEN PURAMINO JUNIOR, dietetic food intended for special medical purposes (application for registration, approved)
- INOGEN ONE G2, portable mobile oxygen concentrator (renewal of registration, approved)
- INOGEN ONE G3, portable mobile oxygen concentrator (renewal of registration, approved)
- AXONICS SNM, rechargeable neuromodulator of sacral roots (application for registration, rejected because the provided data do not demonstrate the interest)
- EPISIL, oral solution (application for registration, rejected because the provided data do not demonstrate the interest)
- PRECISION (reference M365SC1110020), dechexapolar electrode for medullary neurostimulator (cancelled)
- ZEN-O lite RS-00608-G, portable mobile oxygen concentrator (application for registration, approved)
- AIRSOFT DUO, multi-layer foam mattress (application for the amendment of the registration conditions (partly approved) and renewal of registration (approved))
See the list of decisions in French here.
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