FDA Reviews Drug-Eluting Stent Late Loss: More Than A Marketing Concept?
This article was originally published in The Gray Sheet
Executive Summary
Late lumen loss should be regarded strictly in the context of drug-eluting stent safety, because its value as a surrogate measure of efficacy remains unclear, FDA cautions
You may also be interested in...
Surrogate Endpoint For Drug-Eluting Stent Trials Hotly Contested AT TCT
FDA, industry and academia should pool data to determine whether late lumen loss is a viable surrogate endpoint for drug-eluting stent trials, according to CDRH Division of Cardiovascular Devices Director Bram Zuckerman, MD
Surrogate Endpoint For Drug-Eluting Stent Trials Hotly Contested AT TCT
FDA, industry and academia should pool data to determine whether late lumen loss is a viable surrogate endpoint for drug-eluting stent trials, according to CDRH Division of Cardiovascular Devices Director Bram Zuckerman, MD
Guidant To Push DES Program In 2005, Says Champion Fracture Issue Solved
Guidant expects to launch its Champion everolimus drug-eluting stent in Europe in mid-2005, assuming regulators agree that the firm has resolved stress fracture problems related to the device