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: VENOUS WALLSTENT
PMA Applicant: Boston Scientific Corporation
Address: Boston Scientific Corporation, 300 Boston Scientific Way, Marlborough, MA 01752-1234
Approval Date: March 17, 2020
Approval Letter: Approval Order
What is it?
The VENOUS WALLSTENT is intended to treat a narrowed vein found in the upper pelvic region down to the groin area (iliofemoral vein). The VENOUS WALLSTENT has two components: a stent made from braided metallic (elgiloy) wire and an over-the-wire stent delivery catheter system.
The VENOUS WALLSTENT was previously approved to increase the width of a narrowed section of the central veins. This approval expands the indications for use of the VENOUS WALLSTENT to increase the width of the narrowed section of the iliofemoral vein.
How does it work?
The physician inserts a thin flexible tube (delivery system) with a stent loaded within its tip into the narrowed section of the iliofemoral vein. The physician slides back part of the delivery system to expose the stent which then self-expands automatically. The stent increases blood flow from the leg by holding the iliofemoral vein wall open. The stent remains permanently implanted in the vein and supports the newly opened section of the blood vessel.
When is it used?
The VENOUS WALLSTENT is used to reopen narrowed regions of iliofemoral vein caused by a collection of fibrous blood clots that can form along the lining of the veins following a deep vein thrombosis (post-thrombotic syndrome) or the squeezing of the vein between a bone and an overlying artery (iliofemoral compression). These conditions may limit blood flow from the leg and lead to swelling of the leg and pain when walking.
What will it accomplish?
The VENOUS WALLSTENT is intended to hold open the narrowed iliofemoral vein(s) and improve blood flow from the leg.
In clinical studies, 86.6% of patients who received VENOUS WALLSTENT continued to have an open iliofemoral vein after one year. Moreover, statistically significant improvements in pain and quality of life were observed from baseline to 12-months.
When should it not be used?
The VENOUS WALLSTENT should not be used with:
- Patients with uncorrected bleeding disorders.
- Patients who cannot receive blood thinning medications, such as aspirin or coumadin, among others.
- Patients who have a lesion that prevents crossing or complete inflation of an angioplasty balloon or proper placement of the stent or stent delivery system.
Additional information (including warnings, precautions, and adverse events):