FROM: U.S. FOOD AND DRUG ADMINISTRATION
Supera Peripheral Stent System – P120020
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: Supera Peripheral Stent System
PMA Applicant: IDEV Technologies
Address: 253 Medical Center Blvd., Webster, TX 77598
Approval Date: March 28, 2014
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf12/P120020a.pdf
What is it? The Supera Peripheral 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 a small woven tube made of two metals (nickel and titanium). The stent is mounted within the delivery catheter; a long, thin, tube-like device used to deliver the stent into the artery.
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 angioplasty balloon and its catheter are removed. The Supera Peripheral Stent System is advanced through the same vessel and positioned within the expanded artery.
The stent is then released (deployed). The stent opens automatically over the blockage as it is released from the delivery system.
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 Supera Peripheral Stent System is used to treat patients with narrowing of a superficial femoral or proximal popliteal arteries caused by atherosclerosis, the collection of fatty substances such as cholesterol that forms “plaque” along the lining of the arteries. This narrowing may limit blood flow to the legs, leading to pain when walking.
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 the narrowed superficial femoral or proximal popliteal artery, and
Improve blood flow to the legs.
When should it not be used? Use of the Supera Peripheral Stent System is contraindicated in the following cases:
When a patient has a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or stent delivery system.
When a patient cannot receive specific blood thinning medications, such as aspirin or Coumadin, among others.
Additional information: The Summary of Safety and Effectiveness Data and labeling are available online.
