Results from a First-in-Human Trial of a Novel Vascular Sealant.

ABSTRACT:

Background

Suture hole bleeding from synthetic grafts presents a hemostatic challenge. The designs of many vascular sealants are not optimal (non-adherence to wet surfaces, excessive swelling, inflexible). PreveLeak™ (formerly ArterX ((®)) ) is a polyaldehyde-bovine serum albumin-based sealant whose efficacy, safety, and performance were evaluated in this first-in-human study.

Materials and methods

A prospective, single-arm, multicenter study was performed in patients undergoing open vascular reconstructions with prosthetic grafts. Sealant was applied to the suture line after completion of the anastomosis. The primary endpoint was the incidence of immediate sealing (without clinically significant bleeding) upon clamp release. Secondary endpoints were time to sealing, safety,

SUBMITTER: Florek HJ 

PROVIDER: S-EPMC4486749 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature