SEDL / STP / STP898-EB / STP33284S

Physical Properties and Test Methods for Expanded Polytetrafluoroethylene (PTFE) Grafts

McClurken, ME
Director of engineering, director of regulatory affairs, and technical manager, Impra Inc., Tempe, AZ

McHaney, JM
Director of engineering, director of regulatory affairs, and technical manager, Impra Inc., Tempe, AZ

Colone, WM
Director of engineering, director of regulatory affairs, and technical manager, Impra Inc., Tempe, AZ

Pages: 13    Published: Jan 1986

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Abstract

This paper will assist the Food and Drug Administration's efforts to develop rational standards for vascular grafts. Since very little technical information has been published on the physical properties of polytetrafluoroethylene (PTFE) grafts, this paper will also address the concerns of ASTM, clinicians, and graft manufacturers. Detailed descriptions are given for current test methods designed to measure physical dimensions, bulk density, porosity, water entry pressure, longitudinal tensile strength, radial tensile strength, suture retention strength, burst strength, and percent sintered. Grafts made by all three current suppliers were tested according to the described test methods. The results indicate that currently available PTFE grafts have very similar inner surfaces with widely varying outer surfaces. Though variations in design directly influence physical strength, all currently available PTFE grafts appear to possess adequate physical properties to ensure safe clinical use.