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.

FDA seen toughening coated-stent requirements: WSJ

-Reuters

12/14/2007 - The U.S. Food and Drug Administration is planning to release new testing requirements for drug-coated heart stents in the next few weeks, the regulatory agency's device chief, Daniel Schultz, told the Wall Street Journal.

In an article on Friday, the Journal reported that the FDA's revised requirements are in response to safety concerns about the drug-coated stents.

Stents are tiny wire-mesh tubes used to prop open arteries after doctors clear them of blockages. Some stents have a drug coating meant to keep the vessels from reclogging.

Drug-coated stents, made by companies including Boston Scientific Corp, Johnson & Johnson and Medtronic Inc, were once near $6 billion a year market, but that has contracted sharply amid concerns the stents could cause complications. Some patients developed blood clots months after having the devices implanted, and many doctors reverted to older and cheaper bare-metal stents.

The FDA's new guidelines, will likely be stricter around the recommended time patients should take an anticlotting drug after receiving a new stent, and the numbers of patients and length of time used to test new stents, the Journal reported. Under the new guidelines, the testing period could go on before and after the FDA approves the project, according to the newspaper.

The more stringent guidelines are not likely to affect stents that are already on the market, the Journal said.

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.