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 July and August 2019.
Nine (9) decisions were released regarding orthopedic devices:
- OSSDSIGN Cranial PSI, custom bone substitute for the reconstruction of the cranial vault (application for registration, approved)
- TMARS, acetabular reconstruction system (application for registration, approved)
- LP ESP II, a lumbar intervertebral prosthesis (canceled)
- VELOCITY, class III energy recovery foot (application for registration, approved)
- CELSUS, class III energy recovery foot (application for registration, approved)
- PEEK, custom bone substitute for cranial reconstruction (application for registration, approved)
- LP ESP (version II), the total prosthesis of the lumbar disc (renewal of registration, approved)
- FOOT RUSH ROVER PROTEOR, class II energy release foot (application for registration, approved)
- FOOT RUSH PROTEOR for children, child’s energy release foot (application for registration, approved)
Fifteen (15) decisions were released for cardiovascular devices:
- SURPASS EVOLVE, a self-expanding intracranial stent with controlled release (said flow diverter) (application for registration, approved)
- STELLAREX, paclitaxel-eluting balloon (application for modification of the registration conditions, approved)
- FRED and FRED Jr, self-expanding intracranial stents with controlled release (said flow diverter) (application for registration, approved)
- SURPASS STREAMLINE, a self-expanding intracranial stent with controlled release (said flow diverter) (application for registration, approved)
- ZENITH Windows and Multibranche, thoracoabdominal stents (application for registration, approved)
- RELAY PLUS, thoracic aortic stent (application for registration, approved)
- RELAY NBS PLUS, thoracic aortic stent (application for registration, approved)
- Flex Pipeline with Shield Technology, a self-expanding intracranial stent with controlled release (said flow diverter) (application for registration, approved)
- ZENITH FENESTRATED, windowed aortic stent (renewal of registration, approved)
- MRI SR ACCOLADE, single-frequency rate implantable cardiac pacemaker associated with the LATITUDE NXT Remote monitoring system (application for registration, approved)
- MRI DR ACCOLADE, double-chamber frequency-locked implantable cardiac pacemaker associated with the LATITUDE NXT telemonitoring system (application for registration, approved)
- IRM DR EL ACCOLADE, double-chamber frequency-locked implantable cardiac pacemaker associated with the LATITUDE NXT telemonitoring system (application for registration, approved)
- VISIONIST (model U225) associated with the LATITUDE NXT remote monitoring system, implantable cardiac pacemaker with atrio-biventricular pacing for "triple chamber" resynchronization associated with the LATITUDE NXT remote monitoring system (application for registration, approved)
- VISIONIST (model U226) associated with the LATITUDE NXT remote monitoring system, implantable cardiac pacemaker with atrio-biventricular pacing for "triple chamber" resynchronization associated with the LATITUDE NXT remote monitoring system (application for registration, approved)
- VISIONIST (model U228) associated with the LATITUDE NXT remote monitoring system, implantable cardiac pacemaker with atrio-biventricular pacing for "triple chamber" resynchronization associated with the LATITUDE NXT remote monitoring system (application for registration, approved)
Five (5) decisions were released for other devices:
- DC BEAD, controlled release microbead of active substance for hepatic arterial chemoembolization (application for registration, approved)
- PONTO 4, processors for osteo-integrated hearing prosthesis (application for registration, approved)
- I-neb AAD, ultrasonic nebulization system (application for registration, rejected because he available data do not establish the interest)
- Invacare G-trac, trajectory control system for electric wheelchairs INVACARE (application for registration, rejected due to the absence of clinical data)
- GLUCOFIX PREMIUM, device for automatic reading of the blood glucose and ketonemia and GLUCOFIX b-KETONE SENSOR, associated test strips (renewal of registration, approved)
See the list of decisions in French here.
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