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: Carotid WALLSTENT® Monorail® Endoprosthesis
PMA Applicant: Boston Scientific Corporation
Address: 2011 Stierlin Court, Mountain View, California 94043 USA
Approval Date: October 23, 2008
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf5/p050019a.pdf
What is it? The Carotid WALLSTENT ® Monorail ® Endoprosthesis is an implant used to re-open narrowed (stenotic) regions of the carotid arteries in the neck which supply blood to the brain. This device consists of the stent and a stent delivery system. The stent is made of Elgiloy (a metal) wires that are braided in a tubular mesh shape. The stent is mounted onto the delivery catheter: a long, thin, tube-like device.
How does it work? The Carotid WALLSTENT ® Monorail ® Endoprosthesis is inserted into the body through a small cut in the groin and is then guided to the blocked blood vessel in the neck. The stent is then released from the delivery system, and it expands automatically to cover the blocked region and open up the vessel. The delivery system is then removed. This device is typically used together with an embolic protection device, which is used to prevent any loose debris generated during the procedure from reaching the brain.
When is it used? The Carotid WALLSTENT ® Monorail ® Endoprosthesis is used in patients who have had a stroke, or who have a very tight (≥80%) blockage in the vessels of the neck. Patients should also have either medical problems or body abnormalities that would put them at too high a risk to have the surgical alternative (called carotid endarterectomy).
What will it accomplish? The stent is supposed to open blockages in the blood vessel in order to prevent future strokes. When compared to complications reported in literature from patients undergoing surgery, the risk of death, stroke and heart attack at 30 days, or any stroke in the area of the blockage at one year, were similar. In addition, the study showed that the stent still allowed blood flow to the brain more than one year after the procedure.
When should it not be used? Stents should not be used in patients who cannot take blood thinners or who have bleeding disorders, who are allergic to the stent material, who have blockages at the beginning of the neck artery, or who have problems preventing the catheter from getting to the blockage.
Additional information: The Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p050019