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 October 2019.
Seven (7) decision was released regarding orthopedic devices:
- BIOBANK, viro-inactivated bone allograft by SUPERCRIT process (renewal of registration, approved)
- CAPITOL - EVIDENCE (to cement), dual mobility acetabulum consisting of a cemented cup and a conventional polyethylene insert (application for registration, approved)
- CAPTIV DM - EVIDENCE Ti / HAC, dual mobility acetabulum consisting of an uncemented cup and a conventional polyethylene insert (application for registration, approved)
- CAPITOL I - CAPITOL R - EVIDENCE Ti / HAC REVISION, dual mobility acetabulum consisting of an uncemented cup and a conventional polyethylene insert (application for registration, approved)
- CAPITOL U, dual mobility acetabulum consisting of an uncemented cup and a conventional polyethylene insert (application for registration, rejected because the value has not been demonstrated)
- ROTATOR 4R57, rotation adapter for external transfemoral prosthesis (application to change the registration conditions + renewal; approved)
- ROTATOR 4R57 = WR, rotation adapter for external transfemoral prosthesis (application for registration, approved)
Seven (7) decisions were released for cardiovascular devices:
- PERCEPTA QUAD CRT-P SURESCAN MRI, implantable cardiac pacemaker with atrio-biventricular stimulation for resynchronization called "triple chamber" associated with carelink telemonitoring system (application to change the registration conditions, approved)
- percepta crt-p mri surescan, implantable cardiac pacemaker with atrio-biventricular stimulation for resynchronization called "triple chamber" associated with CARELINK telemonitoring system (application to change the registration conditions, approved)
- AZURE XT SR MRI SURESCAN, Single-Frequency Rate Implantable Cardiac Pacemaker Combined with CARELINK Remote Monitoring System (application to change the registration conditions, approved)
- AZURE XT DR MRI SURESCAN, double-chamber implantable cardiac pacemaker associated with the CARELINK telemonitoring system (application to change the registration conditions, approved)
- SAPIEN 3 ™ EDWARDS SYSTEM (CERTITUDE), aortic valve bioprosthesis implanted transapically (CERTITUDE system) (application to change the registration conditions, approved)
- SAPIEN 3 ™ EDWARDS SYSTEM (COMMANDER), aortic valve bioprosthesis implanted transapically (COMMANDER system) (application to change the registration conditions, approved)
- NAVVUS CATHETER, rapid exchange system for measuring the fraction of the coronary reserve flow (FFR) (application for registration, rejected because the provided data do not establish the interest)
- ZENITH t-Branch (standard), thoracoabdominal stent (application for registration, approved)
Ten (10) decisions were released for other devices:
- TENOLIG, percutaneous suture implant of the Achilles tendon (renewal of registration, approved)
- NINO ONE, electric motorized wheel assisting the driving of a manual wheelchair (application for registration, rejected because the value has not been demonstrated)
- Cochlear Implant Systems: MI1250 SYNCHRONY 2 and MI1250 SYNCHRONY 2 PIN, Cochlear Implants - SONNET 2 ME1510 and SONNET 2 EAS ME1520, Sound Processors (application for registration, approved)
- ALBER E-PILOT, traction device with electric drive for manual wheelchair user (application for registration, rejected because the value has not been demonstrated)
- OPUR (bladder hammock kit), bladder retaining implant for transvaginal genitourinary prolapse cure (application for registration, rejected because the value has not been demonstrated)
- AXONICS SNM SYSTEM, rechargeable neuromodulator of sacred roots (application for registration, approved)
- MINIMED SYSTEM 640G, interstitial glucose continuous measurement system coupled to an external insulin pump (application to change the registration conditions, approved)
- PERISTEEN TRANSANAL IRRIGATION system (application to change the registration conditions + renewal; approved)
- GLUCOFIX TECH 2K and GLUCOFIX TECH B-KETONE SENSOR, apparatus for automatic coded reading of blood glucose and ketones and associated test strips for measuring ketones (application for registration, approved)
- NATPAR PEN, NATPAR parathyroid hormone cartridge injector pen (application for registration, approved)
See the list of decisions in French here.
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