The French National Authority for Health (HAS) released new decisions about add-on and medical aid reimbursement of medical devices from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in January 2019. The decisions were brought for eighteen (18) medical devices.
Four (4) decision was released regarding prostheses:
- LARS, Artificial ligament for the knee (application for renewal of registration, approved; application for amendment of the registration conditions, rejected due to the lack of clinical data provided)
- DURASUL (insert and acetabulum), acetabular cup and monoblock insert in highly cross-linked polyethylene (canceled)
- DURASUL (acetabulum), one-piece cup in highly cross-linked polyethylene (application for renewal of registration, approved; application for amendment of the registration conditions, rejected due to the lack of clinical data provided for one additional condition, approved for the other)
- DURASUL (insert), highly crosslinked polyethylene insert, (application for renewal of registration, approved; application for amendment of the registration conditions, rejected due to the lack of clinical data provided for one additional condition, approved for the other)
Four (4) decision was released regarding cardiovascular devices:
- ELUVIA, peripheral active release stent (paclitaxel) (application for renewal of registration, approved; application for amendment of the registration conditions (two new conditions), rejected due to the lack of clinical data provided)
- ZENITH FENESTRATED, an aortic stent (application for amendment of the registration conditions, approved)
- REVEAL LINQ, implantable cardiac monitor (application for registration, approved)
- YUKON CHOICE PC, coronary stent coated with sirolimus (pharmacologically active product) (application for amendment of the registration conditions, approved)
Ten (10) decisions were released regarding other devices:
- ERIS, modular electric scooter (application for registration, approved)
- VISCO (cushion), viscoelastic memory foam cushion (application for renewal of registration, approved)
- AXTAIR AUTOMORPHO PLUS, alternating pressure motorized air mattress pad with associated compressor (application for registration, rejected because the available clinical data do not establish the interest for this product)
- SONALTO, pre-set listening assistant (application for registration, rejected because the available clinical data do not establish the interest for this product)
- SORTEZ COUVERTS, lubricated male condoms (application for registration, approved)
- SNAP Therapy System, negative pressure wound treatment system (application for registration, rejected because the available clinical data do not establish the interest for this product)
- SIR-Spheres, microspheres made of Yttrium-90 (application for amendment of the registration conditions, approved)
- MOBIDERM (standard), limb compression devices (application for registration, rejected)
- ExEm Foam Kit FK05, preparation kit for the hyperechoic product (application for registration, approved)
- FREESTYLE OPTIUM BETA CETONE, an electrode for measuring ketone (application for renewal of registration, approved)
See the full list of decisions in French here.
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