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 September 2019.
One (1) decision was released regarding orthopedic devices:
- DAC, bioabsorbable hydrogel for orthopedic implants (application for registration, rejected because the provided data do not establish the interest)
Eight (8) decisions were released for cardiovascular devices:
- iVASCULAR LUMINOR 18 and 35, paclitaxel-eluting balloon (application for registration, approved)
- COMBO PLUS Stent, coronary stent with sirolimus release (pharmacologically active product) with bioabsorbable matrix coated with anti-CD34 monoclonal antibodies (application for registration, rejected because the provided data do not establish the interest)
- BIOMONITOR 2-AF, implantable cardiac monitor with remote monitoring (application for registration, approved)
- COMBO Stent, coronary stent with sirolimus release (pharmacologically active product) with bioabsorbable matrix coated with anti-CD34 monoclonal antibodies (application for registration, rejected because the provided data do not establish the interest)
- CONFIRM RX model DM3500, implantable cardiac monitor (application for registration, approved)
- LIFEVEST 4000, portable external cardiac defibrillator (application to change the registration conditions, approved)
- BIOMIME, coronary stent (stent) coated with sirolimus (pharmacologically active product) (application for registration, rejected because the provided data do not establish the interest)
- ZENITH Universal Distal Body, stent (application for registration, approved)
NIne (9) decisions were released for other devices:
- CHORUS, sound processor for cochlear implant system (application for registration, approved)
- NUCLEUS CI612, CI622, and CI632, cochlear implants (application for registration, approved)
- POUSSEUR2 PREMIUM, electric motor propulsion device controlled only by the accompanying person (application for registration, approved)
- VTP SYSTEM FOR TOOKAD, consisting of the TOO-DIFFUSER light-diffusing optical fiber, the TOO-PROBE isotropic rectal probe optical fiber, the TOO-CATH S metal end introducer catheter and the TOO-CATH smooth end introducer catheter (application for registration, rejected because the provided data do not establish the interest)
- LYRIC3, permanent-wear in-ear hearing aid (application for registration, rejected because the provided data do not establish the interest)
- TOPCHAIR-S, electric wheelchair climber (renewal of registration, approved)
- PERISTEEN OBTAL, analog obturator tampon (renewal of registration, approved)
- INFASOURCE, foodstuff for special medical purposes for oral and enteral nutrition (application for registration, approved)
See the list of decisions in French here.
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