Development and Physical Characteristics of Novel Zero-Porosity Vascular Graft “Triplex^®"

Abstract

We developed a novel large-diameter graft “Triplex^®" that uses a non-biodegradable material as a coating material. This time, in order to demonstrate the physical properties of Triplex^® grafts, we conducted physical tests in accordance with the international guidelines, using the collagen coated vascular grafts(Hemashield, Boston Scientific, Natick, Massachusetts, USA) as the controls. The grafts were tested with regard to strength (burst strength, circumferential tensile strength, longitudinal tensile strength), suture retention strength, integral water permeability, water leakage (needle puncture, after using clamp), and change in luminal diameter following pacing stress according to ISO7198 and FDA guidance. As indicated by the results, we experimentally demonstrated that uniquely designed vascular graft Triplex^® led to less blood leakage from the vascular graft and less leakage from the needle puncture, although it has fundamental physical properties comparable to those of the vascular grafts using biodegradable material that has been utilized conventionally in clinical settings. Triplex ^®is expected to play its role as a clinically beneficial next-generation vascular graft.