Venous Self-Expanding Stent System Receives FDA Approval
October 28, 2020
The U.S. Food and Drug Administration has granted premarket approval (PMA) for a venous self-expanding stent system developed by Medtronic. The system, called Abre, is designed to help clear obstructions or compression deep in the veins that can cause restricted blood flow to the heart.
FDA approved the system after reviewing results from a year-long study involving 200 patients with oliofemoral venous outflow obstruction. The study reached an 88 percent endpoint effectiveness rate. The system received the European CE mark in 2017.
As a “self-expanding” stent system, Abre is a permanent implant that enables flexibility and stability during the procedure to deploy it.
"Patients with deep venous obstruction are often younger, therefore it's critical to have a venous stent that is not only safe and effective, but also strong and flexible," said Erin Murphy, global principal investigator for the clinical study and director of Atrium Health Sanger Heart and Vascular Institute's Venous and Lymphatic Program in Charlotte, NC, in a press release. "With FDA approval, we now have this important tool in our arsenal to treat patients with even the most challenging of deep venous lesions.