VENOVO Venous Stent System - P180037
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: VENOVO Venous Stent System
PMA Applicant: Bard Peripheral Vascular, Inc.
Address: 1625 West 3rd Street, Tempe, AZ 85281
Approval Date: March 13, 2019
Approval Letter: Approval Order
What is it? The VENOVO Venous Stent System is intended to treat a narrowed vein found in the upper pelvic region down to the groin area (iliofemoral vein). The VENOVO 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 rotates a thumb wheel on 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 acts as a support for the newly opened section of the blood vessel.
When is it used? The VENOVO Venous Stent System 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 VENOVO Venous Stent System is intended to hold open the narrowed iliofemoral vein(s) and improve blood flow from the leg. In the clinical study, 88.3% of patients who received stents 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 VENOVO Venous Stent System should not be used with:
- 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.
- Patients who cannot receive blood thinning medications, such as aspirin or coumadin, among others.
- Patients who have a known hypersensitivity to nickel, titanium, or tantalum.
Additional information (including warnings, precautions, and adverse events):