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Stent standards

This article was originally published in The Gray Sheet

Executive Summary

FDA could adopt up to five new testing standards for vascular stents in early 2003 if the ASTM International Technical Committee on Medical and Surgical Materials and Devices passes the proposed standards in a reballoting scheduled for March and the entire organization approves them in November. The proposed standards include a guide for measuring securement of a stent mounted on a delivery system, a test method for generating stent and stent-graft flexibility curves, a test method for in vitro pulsatile fatigue, a test method for radiopacity and a guide for finite element analysis of radially loaded stents. The committee decided at their September 2001 meeting that drug-eluting stents are too early in development to warrant formal standards in the foreseeable future. Instead, FDA recommends that developers refer to the 1draft consensus report on recommended standards for preclinical studies and evaluation of drug-eluting stents, developed by several leading researchers and clinicians. The ASTM committee will continue to review comments on the draft...
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