First decisions about add-on reimbursement by CNEDiMTS at French National Authority for Health (HAS) from the meeting in April 2017

At the meeting of 18th of April National Commission for Evaluation of Medical Devices and Health Technologies made decisions about add-on reimbursement of 17 medical devices. Ten decisions have been released to date for orthopedic, osteointegrated processing, cardiac and intravascular devices:

• Knee joint system BASKO SPL (Swing Phase Lock) (renewal of registration, approved)
• Viro-inactivated bone allograft BIOBANK for filling of bone loss (registration of additional devices under the same category, approved)
• Intramedullary cement plug AIR PLUG  (renewal of registration, approved)
• Osteo-integrated processing devices PONTO 3, PONTO 3 POWER & PONTO 3 SUPER POWER (registration of additional devices under the same category, approved)
• Implantable cardiac pacemaker with atrio-biventricular stimulation for resynchronization "triple chamber" PERCEPTA CRT-P MRI SURESCAN (application for registration, approved)
• Implantable cardiac pacemaker with atrio-biventricular stimulation for resynchronization "triple chamber" PERCEPTA QUAD CRT-P MRI SURESCAN (application for registration, approved)
• Intrahepatic covered endoprosthesis VIATORR TIPS (request for amendment + renewal of registration, approved)
• Implantable ECG Monitor CONFIRM (modèle DM2102) (application for registration, approved)
• Portable oxygen concentrator with trolley SOLO2 (renewal of registration, approved)
• Aortic valvular bioprosthesis implanted by transcutaneous arterial route COREVALVE EVOLUT R 34mm (renewal of registration, approved)

Decisions are pending about the following technologies:

• ULTIMASTER, coronary endoprosthesis with sirolimus (renewal of condition for registration)
• MAGNEZIX CS, bioresorbable screw for osteosynthesis (application for registration)
• ESSURE, Intrafallopian implant - device for hysteroscopic tubal sterilization (5260 and DM_EVAL-143) (renewal of registration)
• PENUMBRA 3D, thrombus reuptake system (retriever) (5251), PENUMBRA PACKAGE SYSTEM, Thrombus aspiration kit (ACE60 and ACE68) (5235) (application for registration)
• MELODY with percutaneous implant system ASSEMBLY, percutaneous ultrasonic valve with implantation system (5264) (renewal of registration)
• MELODY with percutaneous implant system ASSEMBLE II, Percutaneous pulmonary valve with implantation system (5223) (application for registration)
• RESORB X (range) and SONICPINS RX, Resorbable plates and rivets for craniofacial osteosynthesis (5255) (application for registration)

Publications of opinions for these technologies are awaiting.

The agenda of the meeting in April can be seen in French here.

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