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New Drug Approval: CYPHER™ Sirolimus-eluting Coronary Stent - P020026
CYPHER™ Sirolimus-eluting Coronary Stent - P020026 |
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This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: CYPHER™ Sirolimus-eluting Coronary Stent on RAPTOR™ Over- the-Wire Delivery System; CYPHER™ Sirolimus-eluting Coronary Stent on RAPTORRAIL® Rapid Exchange Delivery System
Applicant: Cordis Corporation
Address: 14201 N.W. 60th Avenue, Miami Lakes, Florida 33014
Approval Date: April 24, 2003
Approval Letter: http://www.fda.gov/cdrh/pdf3/P020026a.pdf
What is it and when is it used? The CYPHER™ Sirolimus-eluting Coronary Stent is an expandable, slotted, stainless steel tube, with a drug (sirolimus) contained within a thin polymer coating on its surfaces. The Stent is mounted over a balloon on the end of a long thin flexible tube called a “delivery catheter” (RAPTOR™ Over- the-Wire Delivery System or RAPTORRAIL® Rapid Exchange Delivery System).
The Stent is used in patients who have a narrowing in their coronary arteries (blood vessels supplying the heart) caused by the collection of fatty substances such as cholesterol along the lining of the coronary arteries, in a process known as atherosclerosis.
How does it work? The Stent, mounted on a balloon catheter (stent delivery catheter), is inserted into a blood vessel in the arm or groin. It is advanced within the vessel to the narrowed section of the coronary artery. When the Stent is correctly positioned within the coronary artery the balloon is inflated, causing the stent to expand. Expansion of the stent pushes the plaque aside, opening the narrowed section of the artery. This restores normal blood flow to the heart. The balloon on the stent delivery catheter is then deflated and the delivery catheter is removed from the patient. The Stent remains permanently implanted within the coronary artery, acting as a support (scaffold) of the newly opened section of the vessel, while the drug (sirolimus) is slowly released into the artery wall around the stent.
What will it accomplish? Expansion of the Stent within the narrowed section of a coronary artery opens the narrowing, allowing more blood flow to the heart. If the narrowing is not treated, it can lead to a heart attack (myocardial infarction) or even death. Sometimes, after a coronary artery stent procedure, re-narrowing of the artery occurs, due to overgrowth of normal tissue that occurs during the healing process. The action of the drug (sirolimus) is intended to limit this overgrowth of normal tissue.
When should it not be used? The CYPHER Stent should not be used in patients:
- who cannot take aspirin or blood-thinning medicine,
- who have an allergy to the drug sirolimus, its derivatives or the polymers used to coat the stent, or
- who have a blockage in the coronary artery that will not allow complete inflation of the balloon.
Additional information: Summary of Safety and Effectiveness and labeling are available at: http://www.fda.gov/cdrh/pdf3/p020026.html
Other:
National Institutes of Health, National Library of Medicine:
- Shows placement of a stent in a coronary artery:
http://www.nlm.nih.gov/medlineplus/ency/presentations/100160_6.htm - Overview of coronary heart disease:
http://www.nlm.nih.gov/medlineplus/ency/article/007115.htm - FDA Talk Paper:
http://www.fda.gov/bbs/topics/NEWS/2003/NEW00896.html
