FDA Approves Iliac Indication for Medtronic's Protégé GPS Stent System

March 18, 2015—Medtronic plc announced that its Protégé GPS self-expanding peripheral stent system has received approval from the US Food and Drug Administration (FDA) for the treatment of stenotic lesions of the common and external iliac arteries. 

According to Medtronic, the Protégé GPS self-expanding peripheral stent system allows physicians to treat iliac artery lesions and restore blood flow with large-diameter stents through a low-profile (6 F) delivery system. The stent is cut from a nitinol tube into an open lattice design and has tantalum radiopaque markers at the proximal and distal ends of the stent. Upon deployment, the stent achieves its predetermined diameter and exerts a constant, outward force to restore patency.

The company advised that the 9-month results of the DURABILITY Iliac study, which were presented in November at the VIVA 2014: Vascular InterVentional Advances meeting in Las Vegas, Nevada, demonstrated the safety and effectiveness of the Protégé GPS peripheral stent system in the treatment of stenotic lesions of the common and external iliac arteries. The prospective, multicenter, nonrandomized DURABILITY clinical study demonstrated 95.8% 9-month primary patency by Kaplan-Meier analysis and 98.6% freedom from target vessel revascularization. Peter Faries, MD, from Mount Sinai School of Medicine in New York, New York, served as co-national principal investigator of the DURABILITY Iliac study.

In the Medtronic press release, Dr. Faries commented, “When used for iliac angioplasty and stenting, the Protégé GPS self-expanding peripheral stent system demonstrated excellent patency rates even in difficult-to-treat calcified lesions. Data from the DURABILITY Iliac study confirms the safety and effectiveness of the Protégé GPS stent. It is gratifying to see that the FDA has approved this stent for the iliac indication.”