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Johnson & Johnson Cypher Stent
FDA Advises Physicians of Adverse Events Associated with
Cordis Cypher Coronary Stents
The Food and Drug Administration (FDA) informed physicians
on October 29, 2003 about adverse events associated with Cordis
Corporation’s Cypher Coronary Stent.
FDA has received more than 290 reports of thrombosis (clotting)
occurring one to 30 days after the procedure to implant the
device. In more than 60 of these reports, use of the device
was associated with the death of the patient; in the remainder,
the device was associated with injury requiring medical or
surgical intervention.
More than 50 reports, including some deaths, that Cordis
considers to be possible hypersensitivity reactions have been
reported to the FDA. The symptoms include: pain, rash, respiratory
alterations, hives, itching, fever, and blood pressure changes.
What is the Cypher Stent?
The CYPHER™ stent is a coronary stent coated with a
thin polymer containing the drug sirolimus. The CYPHER™
stent releases an immunosuppressant drug, sirolimus, intended
to reduce restenosis. For more information on the CYPHER™
stent, see the physician Instructions for Use at http://www.fda.gov/cdrh/pdf3/P020026c.pdf
or the patient guide at http://www.fda.gov/cdrh/pdf3/P020026d.pdf.
FDA approved the Cypher stent in April 2003 for patients
undergoing angioplasty procedures to open clogged coronary
arteries. The stent, a cylindrical metal mesh, is designed
to keep the arteries from re-clogging after the procedure.
It is coated with a thin polymer containing the drug sirolimus
that is slowly released into the patient and is intended to
reduce the rate of re-blockage that occurs with other stents.
Patients who have received this stent should continue to
follow their regularly scheduled plan for follow-up appointments
with their doctor.
As a condition of approval, FDA is requiring Cordis to conduct
a 2000-patient post-approval study and continue evaluating
patients from ongoing clinical trials to assess the long-term
safety and effectiveness of the stent and to look for rare
adverse events that may result from use of the product.
* - Source FDA Talk Paper
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