The French National Authority for Health (HAS) released new decisions about add-on and medical aid reimbursement of 21 medical devices from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in May.
Four decisions were released for cardiovascular devices:
- AZURE XT SR MRI SURESCAN, implantable cardiac pacemaker (application for registration, approved)
- AZURE XT DR MRI SURESCAN, implantable cardiac pacemaker (application for -registration, approved)
- PERCEPTA CRT-P MRI SURESCAN, implantable cardiac pacemaker (application for registration, approved)
- PERCEPTA QUAD CRT-P MRI SURESCAN, implantable cardiac pacemaker (application for registration, approved)
Nine decisions were released for prosthesis:
- TRES, energy return foot (application for registration, approved)
- GLASSBONE, synthetic bone substitute (application for registration, approved)
- AVANTAGE 3P PLASMA TIHA and AVANTAGE REVISION (with no cement), acetabular cup with double mobility (application for registration, approved)
- A2T, ankle orthosis, (application for registration, approved under generic name)
- XLMOB (without cement), acetabular cup with double mobility (application for registration, rejected due to insufficient expected benefit)
- XLMOB (with cement), acetabular cup with double mobility (application for registration, rejected due to insufficient expected benefit)
- GALILEA (with cement), acetabular cup with double mobility (application for registration, rejected due to insufficient expected benefit)
- NANOSTIM, injectable synthetic bone substitute (renewal of registration, approved)
Eight decisions were released for other devices:
- BARRX, radiofrequency ablation system for Barrett's Esophagus (application for registration, approved on title V)
- SEQUENT, meniscal repair system (renewal of registration, approved)
- ACTISORB, active carbon bandage (renewal of registration, approved)
- PROFORE, multilayer compression system (renewal of registration, approved)
- PERENNIADURA 303 et PERENNIAFLEX 304, vagus nerve stimulation electrodes (renewal of registration, approved)
- DEMIPULSE 103 ET DEMIPULSE 104, vagus nerve stimulation generator (renewal of registration, approved)
See list of decisions in French here.
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