This is a brief overview of information related to the FDA’s approval to market this product. For additional information on the product and the basis for the FDA’s approval, follow the links (below) to the summary of safety and effectiveness data (SSED) and the instructions for use (IFU).
Product Name: Complete® SE Vascular Stent System
PMA Applicant: Medtronic Vascular
Address: 3576 Unocal Place, Santa Rosa, CA 95403 USA
Approval Date: September 19, 2013
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf11/P110040a.pdf
What is it? The Complete SE Vascular Stent System is used to re-open narrowed (stenotic) regions of the superficial femoral and proximal popliteal arteries which supply blood to the legs. It consists of two components, the stent and the delivery system. The stent is an implant constructed of nickel-titanium alloy (nitinol) tubing, laser-cut into a mesh shape. The stent is mounted within the delivery catheter; a long, thin, tube-like device.
How does it work?
- A catheter with a deflated balloon at its tip is inserted into a blood vessel in the groin and advanced within the vessel to the narrowed section of the superficial femoral or proximal popliteal artery.
- The balloon is inflated within the narrowed artery to open the artery by pushing the plaque against the artery wall (balloon angioplasty).
- The balloon and its catheter are removed; then the Complete SE Vascular stent and delivery system are advanced through the same vessel and positioned within the expanded artery.
- The stent is then released (deployed) by retracting the outer tube (sheath) after it is positioned in the artery and opens automatically over the blockage.
- The stent placement increases blood flow to the legs by holding the artery wall open.
- Once the stent is deployed, the stent delivery catheter is removed.
- The stent remains permanently implanted in the superficial femoral or proximal popliteal artery and acts as a support for the newly opened section of the vessel.
When is it used? The Complete SE vascular stent system is used to treat patients with narrowing of a superficial femoral or proximal popliteal artery 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 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 superficial femoral or proximal popliteal artery.
- improve blood flow to the leg.
When should it not be used? The Complete SE vascular stent system is contraindicated in:
- patients who have a blockage that will not allow complete inflation of the angioplasty balloon or proper placement of the stent, or
- patients who cannot take aspirin or blood-thinning medications.
Additional information: The Summary of Safety and Effectiveness Data and labeling are available.
- NIH-MedlinePlus - Angioplasty and Stent Placement - Peripheral Arteries
- Society for Vascular Surgery - Peripheral Artery Disease