Ennis & Ennis is dedicated to helping victims of defective and recalled traditional stents as well as the newer drug eluting stents throughout the country. If you or a loved one have been injured as a result of stent malfunction you may be entitled to compensation. For more information about your legal rights or to find out the latest recall information or for a free legal consultation contact our stent injury attorneys today.

CDRH Chief: Drug-Eluting Stent Guidelines on the Way

-FDA News

03/27/2008 - A long-awaited guidance on drug-eluting heart stents is imminent, CDRH Director Daniel Schultz says. The guidance, which should come out in the next few weeks, will address questions about the stents’ safety compared with bare-metal stents, Schultz said at a recent media round table. The agency is working with companies to improve studies for these stents and wants broader patient experience in premarket trials and simple postmarket studies. “The amount of early adoption of drug-eluting stents took everybody by surprise,” Schultz said. He added that the agency needs to strengthen the postmarket piece of the puzzle to understand when problems with devices will arise and learn lessons for designing the next generation of devices.

One way to strengthen postmarket regulation is to improve the way the agency receives and analyzes reports. Two years ago, the FDA began examining this process to identify gaps and opportunities for improvement. The centerpiece of CDRH’s postmarket transformation initiative is a “medical device matrix,” Schultz said. The agency is working toward this by creating product networks that cut across functional units of the center.

If you or a loved one have been injured during surgical placement of a stent or have been injured as a result of an implanted drug eluting stent (drug coated stent) such as the Boston Scientific Taxus stent or the Johnson & Johnson Cypher stent you may be entitled to compensation. To learn more about the stent recalls, for information regarding your legal rights, or the possiblilty of a class action lawsuit contact our stent lawyers for a free, confidential, case evaluation today. Fill out our online case evaluation form or call us toll free at 1-800-856-6405.