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 April 2019.
Nine (9) decisions were released regarding orthopedic devices:
- XLMOB (without cement), dual mobility acetabulum consisting of an uncemented cup and a conventional polyethylene insert or a highly crosslinked polyethylene insert (application for registration, approved)
- DUALIS (without cement), dual mobility acetabulum consisting of an uncemented cup and a highly crosslinked polyethylene insert (application for registration, approved)
- DUALIS (to cement), dual mobility acetabulum consisting of an uncemented cup and a highly crosslinked polyethylene insert (application for registration, approved)
- ROTATOR FEMORAL 1K52, rotation adapter for external transfemoral prosthesis (cancelled)
- HYBRID 1P360, mono-axial knee, microprocessor-controlled joint (renewal of registration, approved)
- ROTATOR FEMORAL 1K52, rotation adapter for external transfemoral prosthesis (application for registration, approved)
- EVORA GRIP and EVORA GRIP 3P, dual mobility cups consisting of an uncemented cup and a conventional polyethylene insert (application for registration, approved)
- AXON-HOOK, myoelectric forceps for external prosthesis of the upper limb (application for registration, approved)
- POLARCUP, double mobility cup with cemented cup and conventional polyethylene or highly cross-linked polyethylene insert (application for amendment of the registration conditions, rejected because the data do not establish the interest for required condition)
Eight (8) decisions were released for cardiovascular devices:
- COROFLEX ISAR NEO, coronary stent coated with sirolimus (pharmacologically active product) (renewal of registration, approved)
- HeartWare, mechanical circulatory assistance device (DACM) with continuous (non-pulsatile) electric intracorporeal left mono-ventricular flow (amendment of the registration conditions, approved)
- COROFLEX ISAR, coronary stent coated with sirolimus (pharmacologically active product) (renewal of registration, approved)
- TREVO PROVUE, stent retriever (cancelled)
- ASSURITY MRI PM1272 equipped with the MERLIN.NET remote monitoring system, single-chamber frequency-controlled implantable pacemaker associated with the MERLIN.NET remote monitoring system (application for registration, approved)
- QUADRA ALLURE MP PM3562 equipped with the MERLIN.NET remote monitoring system, implantable cardiac pacemaker with atrio-biventricular stimulation for "triple chamber" resynchronization associated with the MERLIN.NET remote monitoring system (application for registration, approved)
- ALLURE RF PM3222 equipped with the MERLIN.NET remote monitoring system, implantable cardiac pacemaker with atrio-biventricular stimulation for "triple chamber" resynchronization associated with the MERLIN.NET remote monitoring system (application for registration, approved)
- ASSURITY MRI PM2272 equipped with the MERLIN.NET remote monitoring system, double-chamber frequency-controlled implantable cardiac pacemaker associated with the MERLIN.NET remote monitoring system (application for registration, approved)
Eighteen (18) decisions were released for other devices:
- NUCLEUS CI551, cochlear implant (cancelled)
- NUCLEUS FREEDOM HYBRID, cochlear implant (cancelled)
- URGOCELL AG, dressing with silver (renewal of registration, approved)
- URGOCELL AG BORDER, dressing with silver (renewal of registration, approved)
- URGOTUL AG, dressing with silver (renewal of registration, approved)
- URGOTUL AG LITE, dressing with silver (renewal of registration, approved)
- URGOTUL AG LITE BORDER, dressing with silver (renewal of registration, approved)
- BLINK Intensive Tears (single doses), sterile solution for topical ophthalmic use (application for registration, rejected because the data do not establish clinical relevance in the claimed indications)
- BLINK Intensive Tears (multidose), sterile solution for topical ophthalmic use (application for registration, rejected because the data do not establish clinical relevance in the claimed indications)
- BLINK Intensive Tears PLUS (multidose), sterile solution for topical ophthalmic use (application for registration, rejected because the data do not establish clinical relevance in the claimed indications)
- ALAIR, bronchial thermoplasty catheter (application for registration (title V), approved)
- ORION METRO, modular electric scooter (application for registration, approved)
- DURAFIBER, dressing (application for registration, rejected because the data do not establish interest)
- MOOVCARE POUMON, software for medical telemonitoring of relapses and complications in patients with lung cancer (application for registration, approved)
- NEOCATE JUNIOR, foodstuff for special medical purposes (application for registration, approved)
- PROMOGRAN, matrix with anti-protease effect (application for registration, rejected because the data do not establish interest)
- PLATINUM MOBILE, portable oxygen concentrator (application for the amendment of the registration conditions, approved)
- MEPILEX BORDER PROTECT (sacrum), hydrocellular dressing (application for the amendment of the registration conditions, approved)
See the list of decisions in French here.
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