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Ancure Abdominal Aneurysm StentThe Ancure® Endograft® System is a grafting device used to repair abdominal aneurysms introduced by EndoVascular Technologies (EVT), a subsidiary of Guidant Corporation. EVT received approval by the FDA for Ancure® in September 1999 and recalled the product in March 2001, several months after seven anonymous employees reported the failures and problems with the Ancure® system to the FDA. So far, the Ancure® system has been linked to 12 deaths and other serious injuries. Cordis Coronary Stent On July 8, 2003, the U.S. Food and Drug Administration (“FDA”) reported that the Cordis Corporation (“Cordis”), a Johnson & Johnson company, issued a letter to health care professionals wherein they informed them of the rare but potential risk of thrombosis (blood clots) associated with use of its product, the CYPHER™ Sirolimus-Eluting Coronary Stent (“CYPHER™” stent). In a second warning dated October 29, 2003, the FDA reported that this drug-coated device caused over 290 blood clots among patients 30 days after receiving the device and is linked to deaths in more than 60 clotting cases. The CYPHER™ stent was approved in April of 2003 for patients undergoing angioplasty procedures to open clogged coronary arteries. According to the Cordis website, “The CYPHER™ Sirolimus-eluting Coronary Stent is designed to prevent re-narrowing from occurring within the stent (in-stent restenosis). It consists of a stainless steel coronary stent with a thin coating of drug (sirolimus) on its surfaces. The drug is located within a polymer (plastic) coating. The stent is designed to provide structural support in the artery, while the drug (sirolimus) is slowly released into the artery wall around the stent. The action of the drug (sirolimus) is intended to limit the overgrowth of normal tissue as the healing process occurs following coronary stent implantation. Overgrowth of normal tissue is thought to be a major factor responsible for re-narrowing of the artery after stenting.” If you or a loved one has been injured as a result of a defective stent Click Here so that Glen J. Lerner can personally review the merits of your claim today. |
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