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Cordis Corporation Issues a Health Care Professional Letter Regarding the CYPHER Stent

Cordis Corporation (Cordis) has issued the attached letter to health care professionals to inform them of the rare but potential risk of thrombosis associated with the use of its product the CYPHER Sirolimus-Eluting Coronary Stent (CYPHER stent). This letter also provides clarification on the safe use of the product in accordance with the scientific evidence that led to product approval.

The CYPHER stent was approved in April 2003 for patients undergoing angioplasty procedures to open clogged coronary arteries. Since the product’s introduction it is estimated that over 50,000 patients have received a CYPHER stent. To date, FDA has received 47 Medical Device Reports (MDRs) of stent thrombosis occurring at the time of implantation or within a few days of implantation.

The Food and Drug Administration (FDA) is carefully reviewing the reports of adverse events and is working closely with the company to determine the exact causes and reduce the incidence of thrombosis. From the reports received so far, it is unclear what effect the CYPHER stent has on thrombosis risk and what factors may contribute to the risk. As part of the approval for this product, FDA required Cordis to undertake post-approval studies which will help FDA track adverse events more accurately, as well as help determine whether the thrombosis rate in current clinical experience differs from the rate seen in pre-approval studies.

Until more is known about the situation, FDA fully supports Cordis’ recommendations to health care professionals which may help reduce the incidence of adverse events. These include:

• Selection of the appropriate stent size. The stent size should match the diameter of the vessel as closely as possible.
• Selection of appropriate patients for implantation. The stent is indicated for improving coronary luminal diameter in previously untreated vessels and is not indicated for the treatment of restenosis (reclogging of a previously stented vessel).
• Use of an adequate antiplalelet regimen. Doctors are reminded to give adequate doses of medication that reduce the risk of clot formation.
• Use of the proper technique for stent deployment. The stent should be fully deployed and in contact with the vessel wall. Poor stent deployment is a factor that can increase the thrombosis risk.

In addition, all health care professionals are reminded and encouraged to report their experiences to FDA’s Medical Device Reporting (MDR) System through MedWatch (telephone 1-800-FDA-1088 or www.fda.gov/MedWatch).

Cordis, in cooperation with FDA, will continue to monitor the issue.

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