Medtronic PMA OK’d for Abre Venous Stent

FDA has approved a Medtronic PMA for its Abre venous self-expanding stent system. The device is indicated for use in the iliofemoral veins in patients with symptomatic iliofemoral venous outflow obstruction (also known as deep venous obstruction). “If left untreated, patients can experience leg discomfort and pain, limiting their mobility and quality of life,” the company says. Symptoms of the disease include leg swelling, skin changes, leg ulcers, and pain.

Approval was based on 12-month data from the ABRE clinical study involving 200 patients with iliofemoral venous outflow obstructions. Medtronic says the study met its primary safety endpoint with a 2.0% (4/200) rate of major adverse events within 30 days. It also met its 12-month primary effectiveness endpoint with an overall primary patency rate of 88%. “Despite the challenging patient population, no stent fractures and no stent migrations were reported in the study,” The company adds.