FDA adds Protégé to list of approved iliac stents

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The FDA approved a self-expanding stent system for patients with peripheral artery disease, adding another option for treating blockages in the iliac arteries.

Medtronic received the all-clear to market its Protégé GPS self-expanding peripheral stent system as a treatment for stenotic lesions of the common and external iliac arteries. The agency based its approval on the nonrandomized DURABILITY trial, which showed a 95.8 percent patency rate, according to Medtronic.

The system incorporates a self-expanding nitinol stent with GPS markers at the proximal and distal ends that are designed to facilitate positioning. The Protégé device is compatible with a 6 French profile delivery system.