pps proceeding - Abstract Preview
pps proceeding
Symposium: S17 - Special: CREPEC Student Symposium
Oral Presentation
 
 

Development and homologation of bioadhesives

Dhandapani Vignesh (1), Ringuette Vickie (1), Sirois Marco (1), Vermette Patrick (1)*

(1) Département de Génie Chimique - Université de Sherbrooke - Quebec - Canada

The talk will focus on commercially available medical bioadhesives, their applications and the required steps to homologate new ones. Sutures and staples have been used in post-surgery sealing for a long time now. Research has been directed towards developing biomaterials that could reduce post-operative complications. Bioadhesives have been identified for this purpose, either used alone or as an adjunct, and are in the market for some time. These medical devices can be classified as natural or synthetic, based on their composition. Host responses to bioadhesives have been reported in numerous pre-clinical studies. The different reaction mechanisms leading to bioadhesives formation and their host responses will be discussed. The most common bioadhesives for intracorporeal uses include BioGlue®, Coseal®, TissuGlu®, ProGelTM, Tisseel®, Evicel®, OmnexTM, DuraSeal® and FloSeal®. Their primary applications will be outlined. Regulations governing the safety and effectiveness of bioadhesives, those in the market and under development, have been formulated by the Food and Drug Administration (FDA) and Health Canada in the United States of America (USA) and in Canada, respectively. Thus, a general schematic flowchart depicting the paths to be followed to commercialize bioadhesives in the USA and Canada will be presented.