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: Abre Venous Self-expanding Stent System
PMA Applicant: Medtronic Vascular, Inc.
Address: 3033 Campus Drive, Plymouth, MN, 55441
Approval Date: October 21, 2020
Approval Letter: Approval Order
What is it? The Abre Venous Self-expanding Stent System has two components: a metal stent made from nickel titanium (nitinol) and a stent delivery system used to place the stent in a vein. The stent system is intended to treat deep venous obstruction, which occurs when a vein located in the groin area (iliofemoral vein) becomes narrowed or blocked.
How does it work? The physician inserts into the iliofemoral vein the stent delivery system with a stent loaded within its tip. Once the stent is placed at the right spot in the vein, the delivery system is removed and the stent remains permanently implanted. The stent acts as a support for the newly opened section of the vein and helps increase blood flow from the leg by holding the vein wall open.
When is it used? The Abre Venous Self-expanding Stent System is used to treat deep venous obstruction, a medical condition that may limit blood flow from the leg and lead to swelling of the leg and pain when walking.
What will it accomplish? The Abre Venous Self-expanding Stent System is intended to improve blood flow from the leg. It may help prevent potential complications of deep vein obstruction, such as blood clots that migrate to the lungs (pulmonary embolism), a clot in the leg called a deep vein thrombosis (DVT), or scarring caused by a chronic DVT (post thrombotic syndrome).
In a clinical study that included 200 patients who had post-thrombotic syndrome or iliofemoral compression, approximately 88% of patients who received stents continued to have an open iliofemoral vein after one year.
When should it not be used? The Abre Venous Self-expanding Stent System System should not be used in:
- 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 (anti-coagulation or antiplatelet therapies) during medical procedures.
- Patients who have a known allergy or hypersensitivity to nickel titanium (nitinol).
Additional information (including warnings, precautions, and adverse events):