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: Epic™ Vascular Self-Expanding Stent System
PMA Applicant: Boston Scientific Corporation
Address: Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760
Approval Date: April 13, 2012
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf11/p110035a.pdf
What is it? The Epic™ Vascular Self-Expanding Stent System is a thin, flexible, metal mesh tube that is implanted in the large arteries that supply blood to the pelvis and legs (iliac arteries). It consists of two parts, the stent and the delivery system. The stent is an implant made of a nickel-titanium alloy (nitinol) tubing and laser-cut into a mesh shape. The stent is mounted in a long, thin, tube-like device called the delivery catheter.
How does it work?
- The stent, mounted in the stent delivery catheter, is inserted into a blood vessel in the groin. It is then advanced within the vessel to the narrowed section of the iliac artery.
- Once in place, the stent expands to the size and contour of the vessel. This restores the opening in the artery, improving blood flow to the leg by holding the artery open.
- The delivery catheter without the stent is removed from the patient. The stent remains permanently implanted within the iliac artery, acting as a support for the newly opened section of the vessel.
When is it used? The stent is used in patients who have a narrowing in their iliac arteries caused by atherosclerosis -- the collection of fatty substances such as cholesterol that forms "plaque" along the lining of the arteries.
What will it accomplish? The stent expands the narrowed section of an iliac artery. Once in place, it holds the artery open and improves blood flow to the leg.
When should it not be used? There are no known contraindications.
Additional information: The Summary of Safety and Effectiveness Data and labeling are available online.
- NIH - MedlinePlus - Angioplasty and Stent Placement – Peripheral Arteries
- Society for Vascular Surgery – Peripheral Artery Disease