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New Device Approval

Boston Scientific Liberte™ Monorail™ and Over-the-Wire Coronary Stent Systems - P040016

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 Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval

Product Name: Boston Scientific Corporation® Liberté™ Monorail™ and Over-the-Wire Coronary Stent Systems
Applicant: Boston Scientific Corporation
Address: One Scimed Place , Maple Grove , MN 55311-1566
Approval Date: April 12, 2005
Approval Letter: http://www.fda.gov/cdrh/pdf4/p040016a.pdf

What is it and when is it used? The Liberté™ Monorail™ and Over-the-Wire Coronary Stent Systems consist of an expandable, slotted, stainless steel tube called a stent, mounted over a deflated balloon attached to the end of a long thin flexible tube (stent delivery catheter).

The stent is used in patients who have a narrowing in the blood vessels supplying blood to the heart (coronary arteries) caused by atherosclerosis -- the collection of fatty substances such as cholesterol that forms “plaque” along the lining of the arteries.

How does it work?

• A catheter with a deflated balloon at its tip is inserted into a blood vessel in the arm or groin, and advanced within the vessel, to the narrowed section of the coronary artery.
• The balloon is inflated within the narrowed artery to open the artery by pushing the plaque against the artery wall (balloon angioplasty).
• The angioplasty balloon and its catheter are withdrawn from the patient; then the stent, mounted on another deflated balloon catheter (stent delivery catheter), is advanced through the same vessel and positioned within the expanded coronary artery.
• The balloon on the stent delivery catheter is inflated, causing the stent to expand to the size and contours of the vessel. This restores the opening in the artery allowing normal blood flow to the heart.
• The balloon on the stent delivery catheter is then deflated and the delivery catheter without the stent is removed from the patient.
• The stent remains permanently implanted within the coronary artery, acting as a support (scaffold) for the newly opened section of the vessel.

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.

 When should it not be used?

The Liberté™ stent should not be used in patients who:

• are contraindicated for antiplatelet and/or anticoagulant therapy
• are judged to have a lesion that prevents complete inflation of an angioplasty balloon
• have known allergies to stainless steel

 Additional information: Summary of Safety and Effectiveness and labeling will be available at: http://www.fda.gov/cdrh/pdf4/p040016.html

 Other:

•  National Institutes of Health, National Library of Medicine:
  http://www.nlm.nih.gov/medlineplus/ency/article/002303.htm
• Placement of a stent in a coronary artery:
  http://www.fda.gov/hearthealth/treatments/medicaldevices/stent.html
• Overview of coronary heart disease
  :http://www.fda.gov/hearthealth/
  

Updated April 13, 2005

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