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 2020.
One decision was released for ophthalmological devices: ACRYSOF IQ TORIC, toric monofocal intraocular lens (application for registration; sufficient clinical benefit; level III clinical added value compared to monofocal intraocular lenses).
Four (4) decisions were released for cardiovascular devices:
- OPSIRO, coronary stent of the active principle (request for modification of registration conditions; sufficient clinical benefit; level V clinical added value compared to other active coronary stents already covered in the selected indications)
- OPSIRO MISSION, coronary stent of the active principle (application for registration; sufficient clinical benefit; level V clinical added value compared to OPSIRO)
- COREVALVE EVOLUT PRO, aortic valve bioprosthesis implanted by the transcutaneous arterial route (application for registration; sufficient clinical benefit; level V clinical added value compared to other aortic valve bioprostheses implanted via the transcatheter route)
- COREVALVE EVOLUT R, aortic valve bioprosthesis implanted by the transcutaneous arterial route (application for registration; sufficient clinical benefit; level V clinical added value compared to other aortic valve bioprostheses implanted via the transcatheter route)
Five (5) decisions were released for orthopedic devices:
- CHUP AIRE version 1, therapeutic shoes for prolonged use (application for registration; sufficient clinical benefit; level V clinical added value compared to other therapeutic shoes for prolonged use listed in the LPPR)
- CHUP DOUAI, therapeutic shoes for prolonged use (application for renewal; sufficient clinical benefit; level V clinical added value compared to other therapeutic shoes for prolonged use listed in the LPPR)
- AVANTAGE 3P PLASMA TIHA, dual mobility cup (application for registration; sufficient clinical benefit; level V clinical added value compared to simple mobility cups with a conventional polyethylene insert)
- ENERGY FOOT, foot prosthesis of class 1 (application for registration; sufficient clinical benefit; level V clinical added value compared to other class 1 feet prostheses)
- CHUP DAX, therapeutic shoes for prolonged use for adults (application for renewal; sufficient clinical benefit; level V clinical added value compared to other therapeutic shoes for prolonged use listed in the LPPR)
Six (6) decisions were released for other devices:
- ASSANIS, type 2 surgical mask (application for registration; sufficient clinical benefit; level V clinical added value compared to other type 2 surgical masks)
- CAIRFLOW PM100A EVO DIGITAL, alternating pressure motorized air mattress with associated compressor (application for registration; sufficient clinical benefit; level V clinical added value compared to CAIRFLOW PM100A EVO of the previous generation)
- AQUACEL FOAM PRO (sacrum), hydrocellular dressing (application for registration; sufficient clinical benefit; level V clinical added value compared to other hydrocellular dressings in the LPPR)
- AQUACEL FOAM PRO (talon), hydrocellular dressing (application for registration; sufficient clinical benefit; level V clinical added value compared to other hydrocellular dressings in the LPPR)
- IRYFIX, stoma obturator (application for renewal, sufficient clinical benefit; level IV clinical added value compared to mini fecal collection bags
- ALBER SMOOV ONE O10, electric propulsion assistance device for manual wheelchairs (application for registration; sufficient clinical benefit; level V clinical added value compared to electric propulsion assistance devices with user control listed in the LPPR (SMARTDRIVE MX2+, ALBER E-MOTION, ALBER TWION)).
See the latest decisions in French here.
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