Decisions about add-on reimbursement for medical devices in France in November 2019

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 November 2019.

Five (5) decision was released regarding orthopedic devices:

• UNLOADER ONE SMARTDOSING, articulated knee relief orthosis (application for registration, rejected due to the absence of specific clinical data)
• NARVAL ORM, custom mandibular advancement orthosis  (application to change the registration conditions + renewal; approved)
• JUGGERSTITCH, arthroscopic meniscal repair system (application for registration, approved)
• EXABONE PUTTY, absorbable synthetic bone substitute (application for registration, approved)
• EXABONE PASTE, absorbable synthetic bone substitute (application for registration, approved)

Seven (7) decisions were released for cardiovascular devices:

• MITRACLIP NTR, mitral repair clip edge to edge (application to change the registration conditions; approved)
• MITRACLIP XTR, mitral repair clip edge to edge (application to change the registration conditions; approved)
• ISTENT INJECT W, micro-stent trabecular bypass (application for registration, approved)
• Ellipsys, vascular access system for percutaneous creation of an arteriovenous anastomosis by thermofusion (application for registration, rejected because the provided data do not establish the interest)

• PROMUS PREMIER BTK (PROMUS PREMIER OVER THE WIRE BTK and PROMUS PREMIER MONORAIL BTK), peripheral stent with release of active ingredient (everolimus) (renewal of registration, approved)
• WALLSTENT-UNI, self-expanding bare stent (renewal of registration, approved)
• TALEO, class III energy restoring foot (application for registration, approved)

Six (6) decisions were released for other devices:

• FREESTYLE COMFORT, portable mobile oxygen concentrator (application for registration, approved)
• NEOCATE, food for special medical purposes (renewal of registration, approved)
• INTERSTIM II, neuromodulator of the sacred roots (renewal of registration, approved)
• CARPO 2 SE, modular electric scooter (application for registration, approved)
• INNOSPIRE GO, vibrating screen nebulization system (application for registration, approved)
• AEROLIGHT with EXTRANEB + nebulizer, pneumatic nebulization system (application for registration, approved)

See the list of decisions in French here.

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