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: Innova Vascular Self-Expanding Stent System
PMA Applicant: Boston Scientific Corporation
Address: One Scimed Place, Maple Grove, MN 55311
Approval Date: July 21, 2015
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf14/P140028a.pdf
What is it? The Innova is used to re-open narrowed regions of an artery that supplies blood to the leg. It consists of two components, the stent and the delivery system. The stent is a small tube made of a nickel and titanium alloy (nitinol). It 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 leg artery (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 Innova Vascular Self-Expanding Stent System is advanced through the same blood 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 leg by holding the artery wall open.
- Once the stent is deployed, the stent delivery catheter is removed.
- The stent remains permanently implanted in the leg artery and acts as a support for the newly opened section of the blood vessel.
When is it used? The Innova Vascular Self-Expanding 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. This narrowing may limit blood flow to the leg, 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 leg.
When should it not be used? The Innova Vascular Self-Expanding Stent System should not be used if:
- A patient has a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or stent delivery system.
- A patient has a severe blood clot in their vessel or lesion site before or after undergoing an angioplasty procedure.
- 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.