Authors' objectives: The National Committee for the Evaluation of Medical Devices and Health Technologies [CNEDiMTS] received a file requesting inclusion of an epiretinal prosthesis system called ARGUS II on the list of products and services qualifying for reimbursement [LPPR]. Since the associated procedures are not included in the Common Classification of Medical Procedures [CCAM], an evaluation of these procedures was also carried out. This work was carried out according to a special approach linked with the innovative nature of this device, taking into account the high potential for improving the management of patients affected with retinitis pigmentosa. For innovative technologies, the aim of the Haute Autorité de Santé (HAS) is to reduce assessment duration as much as possible, while avoiding: - a premature access to an insufficiently assessed technique, with an excessive health and/or financial risk as a consequence; - a delay in making them available for the care system,when they bring about progress. The evaluation involves the ARGUS II epiretinal implant of Second Sight Medical and associated procedures (implantation, explantation, repositioning).

Authors' recommendations: In the state of the knowledge, the expected benefit of the ARGUS II epiretinal prosthesis is insufficient. To consider immediate generalised reimbursement of the device and procedure is premature in the light of the clinical data available. However, the potential benefit of this technique is considerable. It is therefore essential to encourage and support the collection of additional real-life clinical data through well-conducted studies, considering the high potential of this innovative technology. This would make it possible to compensate for the disability of patients affected by blindness caused by a rare pathology, for whom to date there is no treatment. The proposal for a study as formulated by the working group commissioned by HAS would constitute a first step.

Project Status: Completed

Year Published: 2012

URL for published report: http://www.has-sante.fr/portail/upload/docs/application/pdf/2012-12/rapport_evaluation_dune_prothese_epiretinienne_et_de_son_acte_dimplantation.pdf

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: France

Organisation Name: Haute Autorité de Santé

Contact Address: 2 avenue du Stade de France, 93218 Saint-Denis La Plaine Cedex, France. Tel: +33 01 55 93 71 88; Fax: +33 01 55 93 74 35;

Contact Name: has.seap.secretariat@has-sante.fr

Contact Email: has.seap.secretariat@has-sante.fr