The Food and Drug Administration (FDA) granted Fast Track status to Vascugel for the prevention of hemodialysis access failure.
Vascugel, a novel endothelial cell-based therapy, aims to regulate the body's healing response after vascular access surgery. In two Phase 2-clinical trials of patients requiring a permanent arteriovenous (AV) access for hemodialysis, Vascugel exhibited encouraging efficacy trends, including improved duration of patency and a delay in time to first intervention compared with placebo, noted Pervasis Therapeutics, the company developing the therapy, in a news release. It was also shown to be safe.
Vascugel is placed on the outside of the blood vessel at the arteriovenous access site during the surgery to create the access point. The endothelial formulations in the therapy secrete factors that combat inflammation and promote proper vascular healing. After approximately four to eight weeks, Vascugel is resorbed by the body.
© 2011 Lippincott Williams & Wilkins, Inc.