Decisions about add-on reimbursement for medical devices in France in January 2020

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 January 2020.

Ten (10) decisions were released for cardiovascular devices:

• CRE8, coronary stent coated with sirolimus (pharmacologically active product) (application for renewal, approved)
• ZILVER PTX, the peripheral stent (registration for renewal, approved)
• PENUMBRA SYSTEM including the PENUMBRA JET 7 distal access catheter; and PENUMBRA SYSTEM including the PENUMBRA JET D reperfusion catheter, thrombo-aspiration system (application for registration, approved)
• PENUMBRA SYSTEM including the PENUMBRA ACE 68 distal access catheter; and  PENUMBRA SYSTEM including the PENUMBRA ACE 60 reperfusion catheter, thrombo-aspiration system (application for registration, approved)
• CRE8 EVO, coronary stent coated with sirolimus (pharmacologically active product) (application for renewal, approved)
• E-LIAC, iliac bifurcation stent (application request, rejected because the data do not establish the interest for this technology)
• SOLITAIRE X, stent retriever (application for registration, approved)
• SUPRAFLEX CRUZ, coronary stent coated with sirolimus (pharmacologically active product) (registration for renewal, approved)
• SUPRAFLEX, coronary stent coated with sirolimus (pharmacologically active product) (registration for renewal, approved)
• FIREHAWK, coronary stent coated with sirolimus (pharmacologically active product) (application for modification of registration conditions, approved)

Six (6) decisions were released for orthopaedic devices:

• Transtibial Light Cover (application for registration, approved)
• PEEK, custom bone substitute for cranial reconstruction (application for modification of registration renewal, approved)
• BHR (BIRMINGHAM HIP RESURFACING), total hip resurfacing prosthesis (application for renewal, approved)
• PIED RUSH CHOPART PROTEOR, energy-restoring foot for lower leg amputation (application for renewal, approved)
• ORION3, hydropneumatic mono-axial knee with microprocessor (application for registration, approved)
• C + TBA ALLOTEC, viro-inactivated bone allograft (application for modification of registration conditions, approved)

Thirteen (13) decision was released for other devices:

• NEURX DPS RA / 4, intra-diaphragmatic phrenic stimulator (registration for renewal, approved)
• SIF&LOKI, hair cap (application for registration, approved)
• PROLAFIX-V, implantable devices for vaginal treatment of prolapsed pelvic organs (Intra-GHS registration request, rejected because the data do not establish the interest for this technology)
• CLINUTREN THICKENUP CLEAR, food for special medical purposes for oral nutrition (application for registration, approved)
• ANTERIOR SWIFT, implantable devices for vaginal treatment of prolapsed pelvic organs (Intra-GHS registration request, rejected because the data do not establish the interest for this technology)
• MEPILEX BORDER PROTECT SACRUM and HEEL, hydrocellular dressings (application for modification of registration conditions, rejected)
• PHARMA FORM KALLI VISCO, memory foam cushion (application for modification of conditions + registration renewal, approved)
• PHARMA FORM PRIMA CUSHION, memory foam cushion (application for modification of conditions + registration renewal, approved)
• PHARMA FORM PRIMA PLOT CUSHION, memory foam cushion associated with a pelvic stabilization stop (application for modification of conditions + registration renewal, approved)
• PHARMAFORM ISKIO BI MATERIAL CUSHION, memory foam cushion (application for modification of conditions + registration renewal, approved)
• DOMUS 4 AUTO, alternating pressure motorized air mattress with associated compressor (application for registration, approved)
• MATRX CONTOUR VISCO NG, memory foam cushion (application for registration, approved)
• FLOW COLLECTOR, drainable collector system for high flow liquid stools (application for modification of conditions + registration renewal, approved)

See the news in French here.

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