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: Express® LD Iliac Premounted Stent System
Manufacturer: Boston Scientific Corporation
Address: One Boston Scientific Place, Natick, MA 01760
Approval Date: March 5, 2010
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf9/P090003a.pdf
What is it?
The Express® LD Iliac Stent is an expandable, mesh-like stainless steel tube. The stent is mounted over a deflated balloon attached to the end of a long thin flexible tube called a stent delivery catheter. The Express LD Iliac Stent acts like a support (scaffold) by holding open an artery in the pelvis or legs (iliac artery) to maintain adequate blood flow to the legs.
When is it used?
The Express LD Iliac Stent is used to treat patients with narrowing of an iliac artery 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 region between the abdomen and thigh (groin), and advanced within the vessel, to the narrowed section of the iliac 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- The angioplasty balloon and its catheter are withdrawn from the patient; then the stent, mounted on another deflated balloon catheter (the stent delivery catheter), is advanced through the same vessel and positioned within the expanded iliac 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 leg.
- 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 iliac artery, acting as a scaffold for the newly opened section of the vessel.
- The delivery catheter and balloon are removed, followed by the guiding wire.
What will it accomplish?
The inside lining of the artery will grow over the stent approximately 8 weeks after it is implanted. Once in place, the stent acts as a scaffold to:
- hold open a narrowed iliac artery, and
- improve blood flow to the legs.
When should it not be used?
Generally, patients who are not suitable candidates for balloon angioplasty are also not suitable candidates for stent placement. Other types of patients who may not be good candidates for placement of the Express LD Iliac include:
- Patients who exhibit persistent blood clots in the blood vessels near the treatment site, following use of drugs that dissolve clots.
- Patients with uncorrected bleeding disorders or patients who cannot receive blood thinners.
- Persons with known allergies to stainless steel or its components (for example, nickel).
- A treatment site that is within or adjacent to a weakening of the wall of an artery (aneurysm).
- Patients who experience the complication of a puncture of an artery or the formation of a weakened sac-shaped or widened artery wall during the procedure, preceding possible stent implantation.
- Patients with excessive blood vessel twisting or bending.
- Patients with punctured blood vessels evidenced by contrast media exiting the vessel into the surrounding tissue.
Summary of Safety and Effectiveness and labeling will be available at: