Cordis, a unit of
Johnson & Johnson
, sent a letter to health care professionals informing them of the rare but potential risk of thrombosis associated with the use of its Cypher stent, according to a statement on the Food and Drug Administration's Web site.
The Cypher stent was approved in April for patients undergoing angioplasty procedures to open clogged coronary arteries. Since the product's introduction, estimates indicate that more than 50,000 patients have received a Cypher stent. To date, the FDA has received 47 reports of stent thrombosis occurring at the time of implantation or within a few days of implantation.
The FDA is reviewing the reports and said it's working with the company to determine the exact causes and to reduce the incidence of thrombosis. From the reports received so far, the agency said it's unclear what effect the Cypher has on the risk of thrombosis and what factors may contribute.
As part of the approval for the product, the FDA required Cordis to undertake postapproval studies that will help regulators track adverse events more accurately and determine whether the thrombosis rate differs from the rate seen in preapproval studies.
Cordis has recommended that doctors select the correct stent size and make sure that appropriate patients are chosen to be implanted with the stent. Additionally, the company said health care providers should use an adequate antiplalelet regimen, along with the proper technique for deploying the stent.
Shares of Johnson & Johnson were down 73 cents, or 1.4%, to $52.25 on the
New York Stock Exchange