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 August 2017. They include different types of stents and stent-grafts for multiple indications (coronary, peripheral vascular), mechanical thrombectomy devices for stroke, medical devices applied for treatment of ulcer of venous origin, remote monitoring for Implantable Cardioverter Defibrillator Systems (ICDS):
- Two decisions in relation to coronary stents and balloons:
- PANTERA LUX, coronary paclitaxel-releasing balloon (application for registration, approved only for two of three proposed indications/ first restenosis after stenting procedure with bare metal stents or drug-eluting stents)
- COROFLEX ISAR NEO, coronary drug-eluting stent (application for registration, approved)
- Two decisions for peripheral vascular stent and drug-coated balloon:
- GORE VIABAHN, peripheral vascular stent (request for amendment + renewal of registration, approved)
- LUTONIX 035, peripheral vascular paclitaxel-releasing balloon (application for registration, approved)
- Three decisions for medical devices applied for intracranial thrombectomy:
- SOLITAIRE PLATINUM, stent retriever (application for registration, approved)
- SEPARATOR 3D PENUMBRA, stent retriever (application for registration, rejected)
- PENUMBRA SYSTEM, aspiration thrombectomy device (application for registration, approved)
- Two decisions for devices ulcer of venous origin:
- VENOTRAIN ULCERTEC 39, venous compression stoking (request for amendment of indication, approved)
- VENOTRAIN ULCERTEC 46, venous compression stoking (request for amendment, approved)
Additionally, HAS approved 15 applications for renewal of registration of systems for remote monitoring for Implantable Cardioverter Defibrillator Systems (ICDS) that manufactured by five medtech companies:
- St Jude Medical
- Biotronik
- LivaNova
- Medtronic
- Boston Scientific
Other decisions of CNEDiMTS in August include:
- KETO DIASTIX, test strips for the determination of glucose and ketones in the urine (application for renewal of registration, approved)
- ECLIPSE 5, portable oxygen concentrator (application for registration, approved)
See list of decisions here.
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