VICI VENOUS STENT® System - P180013
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: VICI VENOUS STENT® System
PMA Applicant: Boston Scientific Corporation
Address: Three Scimed Place, Maple Grove, MN 55311
Approval Date: May 2, 2019
Approval Letter: Approval Order
What is it?
The VICI VENOUS STENT® System is intended to treat a narrowed vein found in the upper pelvic region down to the groin area (iliofemoral vein). The VICI VENOUS STENT® System has two components: a stent made of a nickel-titanium alloy (nitinol) tubing and an over-the-wire stent delivery catheter system.
How does it work?
The physician will insert a thin flexible tube (delivery system) with a stent loaded within its tip into the narrowed section of the iliofemoral vein. The physician pulls back on the outer shaft 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 iliofemoral vein.
When is it used?
The VICI VENOUS STENT® System is used to reopen narrowed regions of the iliofemoral vein caused by a collection of blood clots that can form along the lining of the veins following a deep vein thrombosis (post-thrombotic syndrome) or the squeezing of the iliofemoral 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 VICI VENOUS STENT® System opens the narrowed iliofemoral vein to improve blood flow from the leg. In a clinical study, which included 170 patients who had post-thrombotic syndrome or iliofemoral compression, approximately 84% of patients who received stents continued to have an open iliofemoral vein after one year.
When should it not be used?
The VICI VENOUS STENT® System should not be used in patients who:
- Have a lesion that prevents complete inflation of a balloon dilatation catheter or proper placement of the stent or the stent delivery system.
- Cannot receive blood thinners (anti-coagulation) therapy during a procedure.
Additional information (including warnings, precautions, and adverse events):
- Summary of Safety and Effectiveness Data (SSED)
- Patient Labeling: Patient Information Guide - About Venous Outflow Obstruction
- Physician Labeling: Instructions for Use
- PMA Database Entry