Drug-Eluting Stents Will Be Evaluated In Human Trials At Five Firms In 2001
This article was originally published in The Gray Sheet
Executive Summary
At least five companies are planning trials of drug-eluting stents in 2001 with the hope of confirming positive initial data showing the devices help prevent restenosis.
You may also be interested in...
FDA Will Define Preclinical Testing Requirements For Drug-Coated Stents
Preclinical data requirements for drug-eluting stent sponsors will be addressed in a forthcoming FDA guidance. Items to be covered include material analysis, integrity and fatigue testing, stent/catheter system testing, and animal testing, according to Center for Devices and Radiological Health reviewers.
FDA Will Define Preclinical Testing Requirements For Drug-Coated Stents
Preclinical data requirements for drug-eluting stent sponsors will be addressed in a forthcoming FDA guidance. Items to be covered include material analysis, integrity and fatigue testing, stent/catheter system testing, and animal testing, according to Center for Devices and Radiological Health reviewers.
Drug-Eluting Stents Clear Safety Hurdles Associated With Radiation - Serruys
Clinical trials exploring the use of drug-eluting stents to treat in-stent restenosis have avoided some of the initial complications raised by intravascular brachytherapy procedures, according to the lead investigator for trials evaluating Johnson & Johnson/Cordis' Sirolimus-coated BxVelocity stent.