FDA Gives Green Light to ev3’s Protégé GPS Self-Expanding Stent System

The FDA has approved ev3’s Protégé GPS Self-Expanding peripheral stent system for use in the iliac arteries, which supply blood to the pelvis and legs. The stent is intended to open arteries that have been narrowed as a result of plaque formation.

Protégé GPS consists of two parts — the stent and the delivery system. The stent, a nickel-titanium alloy tube laser cut into a mesh shape, is mounted in a long, thin, tube-like delivery catheter. The stent remains permanently implanted, acting as a support for the newly opened section of the artery, the FDA said.

The stent system is contraindicated in patients who are not candidates for balloon angioplasty or stent placement, patients who can’t take anticoagulation drugs, those with allergies to metals in the stent and patients with a blockage that will not allow complete inflation of the balloon or proper placement of the stent, the agency said.

ev3 is a subsidiary of Covidien. — Kellen Owings