Heart Stents

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Coronary Heart Stent

After Johnson & Johnson''s Cypher drug-coated coronary stent was first approved for marketing in April 2003, sales were immediate. Coronary artery diseases are the leading cause of death for men and women in the U.S., as well as in Europe. The addition of the drug-coated coronary stent is believed to greatly reduce risk of restenosis. Popularity of the coronary stent was obvious, as over 50,000 of the stents were used in patients in the three months after its approval.

Cypher coronary stent is a tiny metal scaffold coated with a thin polymer and the drug Sirolimus. Not long after the Cypher coronary stent was approved, the FDA began to receive adverse event reports. The reports included serious side effects, such as 34 instances of blood clots in Cypher recipients resulting in five deaths.

By October 2003, the FDA issued a second warning on the Cypher coronary stent. The agency had received over 290 reports of blood clots associated to the use of the Cypher coronary stent, and in more than 60 of the reports, the patient died. If a drug-coated coronary stent has been used, the patient must take anti-clotting drugs for 3 months following the procedure, opposed to two weeks with the traditional metal stents.

At the end of November 2003, the FDA issued updated information on Cypher coronary stents, saying it had closely monitored the higher than expected number of blood clot reports and had concluded the coronary stent was still a safe and effective device. It is essential to have a proper size and expert implantation performed to reduce risks of suffering potentially deadly events due to the coronary stent. Estimated to be a $3 billion market in the United States by the end of 2004, coronary stents are expected to be heavily used in treating coronary artery diseases.

Product Liability Breaking News

"Serious Danger from Drug-Coated Stents"

Over 2,000 patients every year are suffering avoidable injury and death as a result of stents, small metal devices used to hold open heart arteries, according to two doctors who wrote an editorial published in a leading medical journal.

The ar...

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"FDA will take no further action against Boston Scientific Corp.’s heart stents"

Despite reports of more injuries related to Boston Scientific Corp.’s heart stents, the FDA said they did not plan on taking any further action against the company. Last year, Boston Scientific recalled more than 99,000 Taxus heart stents following re...

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