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 March 2019.
Eight (8) decisions were released regarding orthopedic devices:
- TRITON LP, class III energy recovery foot (application for registration, approved)
- C-WALK 1C40, (renewal of registration, approved)
- C + TBA ALLOTEC, viro-inactivated bone graft (application for registration, approved)
- 1H11Y DYNAMIC CARBON FOOT AND POLYURETHANE HEEL, class I energy restitution foot (application for registration, approved)
- ACOR (to cement), cemented anatomical femoral stem with a modular neck (application for registration, approved)
- ACOR (without cement), uncemented anatomical femoral stem with modular neck (application for registration, approved)
- OPTIMAL, uncemented anatomical femoral stem with a modular neck (application for registration, approved)
- Single and dual mobility cups (application for the amendment of the registration conditions, approved)
Ten (10) decisions were released for cardiovascular devices:
- VALIANT with CAPTIVIA installation system, a thoracic aortic stent (renewal of registration, approved)
- MISTENT, coronary stent coated with sirolimus (pharmacologically active product) (application for registration, approved)
- XIENCE ALPINE, a coronary stent coated with everolimus (pharmacologically active product) (application for the amendment of the registration conditions, approved)
- XIENCE XPEDITION, coronary stent coated with everolimus (pharmacologically active product) (application for the amendment of the registration conditions, approved)
- XIENCE SIERRA, coronary stent coated with everolimus (pharmacologically active product) (application for the amendment of the registration conditions, approved)
- GORE EXCLUDER, Iliac bifurcation stent (cancelled)
- FIREHAWK, coronary stent coated with sirolimus (pharmacologically active product) (application for registration, approved)
- LAMBRE, transcutaneous closure device of the left atrial appendage (application for registration, approved)
- RESOLUTE INTEGRITY, coronary stent coated with zotarolimus (pharmacologically active product) (renewal of registration, approved)
- RESOLUTE ONYX, a coronary stent coated with zotarolimus (pharmacologically active product) (renewal of registration, approved)
Fourteen (14) decisions were released for other devices:
- 3D-CUT, custom instrument (single-use) for osteotomy of primary malignant tumor resection of bone (application for registration (title V), approved)
- HIRES ULTRA 3D with electrodes HIFOCUS MIDSCALA and SLIM J (cochlear implant), (application for registration, approved)
- ZEPHYR, endobronchial valve system (application for registration, approved)
- NAIDA CI70, a sound processor (cancelled)
- DE17L, pre-set listening assistant (application for registration, rejected because the provided data do not demonstrate the interest)
- OPUS2, sound processor (delisted)
- SONNET and SONNET EAS, sound processors (delisted)
- CONCERTO ABI / CONCERTO PIN ABI, brain stem implants (delisted)
- CONCERTO / CONCERTO PIN, cochlear implant (delisted)
- SOLITAIRE AB, an intracranial stent (delisted)
- Synergo RITE, radiofrequency thermo-chemotherapy system (application for registration (title V), approved in the adjuvant treatment of high-risk non-infiltrating muscle bladder tumors, second-line after failure of BCG-therapy, in the case of contraindication or refusal by the patient of radical surgical treatment (total cystectomy); rejected as adjunctive therapy for non-infiltrating muscle bladder tumors as first-line therapy)
- INOGEN ONE G4, mobile oxygen concentrator (portable) (application for the amendment of the registration conditions, approved)
- FLOWGATE2, a balloon guide catheter (application for registration (title V), approved)
- MERCI, balloon guide catheter (application for registration (title V), approved)
See the list of decisions in French here.
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