Authors' objectives: The CEDIT, the hospital based HTA agency of the Paris University Hospital (AP-HP), has already assessed Vivostat® in 2006 and concluded at the time that the available data was insufficient to recommend its dissemination for clinical practice. However, in order to encourage the evaluation of innovative medical devices, the CEDIT has recommended its use to be undertaken into a clinical study, allowing a possible later dissemination and use. This clinical study was not realized. Eight years later, the CEDIT assessed again the usefulness of the autologous fibrin sealant Vivostat® produced by Vivostat A/S.

Authors' recommendations: Few data are available on Vivostat® compared with that published for other fibrin sealants. Moreover, no clinical study directly compared Vivostat® to these products. Vivostat® is thus a medical device whose clinical, economic and organizational benefits are not currently proved. Nevertheless, this product being considered as potentially interesting by surgeons, CEDIT considers that the use of Vivosta® should be made possible at AP-HP, providing that it is carried out into a randomized comparative clinical study, or at least into a cohort study compared with historical or contemporary references. For this study, the manufacturer is invited to provide the devices and machines needed. The costs involved to set up and manage the clinical study could be discussed as part of the procedure recently put in place at AP-HP in order to encourage the evaluation of innovative medical devices. If the possibility of a submission for a national call of proposals is favored, a "Programme de Recherche Médico-Economique" (PRME) seems compatible to the current stage of development of Vivostat®

Project Status: Completed

Year Published: 2015

URL for published report: http://cedit.aphp.fr/vivostat-fibrin-sealant/

English language abstract: An English language summary is available

Publication Type: Not Assigned

Organisation Name: Cellule Innovation of the AP-HP

Copyright: Comite d´Evaluation et de Diffusion des Innovations Technologiques (CEDIT)