The Protégé GPS self-expanding peripheral stent system (Medtronic) has received approval from the FDA for the treatment of stenotic lesions of the common and external iliac arteries. The news follows the nine-month results of the DURABILITY Iliac study, which were presented at the VIVA conference in Las Vegas in November 2014.
The DURABILITY Iliac study results 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, multicentre, non-randomised clinical study demonstrated 95.8% nine-month primary patency by Kaplan-Meier analysis and 98.6% freedom from target vessel revascularisation.
“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,” said Peter Faries, co-national principal investigator of the DURABILITY Iliac study, Mount Sinai School of Medicine, New York, USA. “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.”
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, 6F profile 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 Protégé GPS self-expanding peripheral stent system is designed to enhance delivery, deployment and visibility during peripheral vascular procedures,” said Mark Turco, medical director of the Aortic and Peripheral Vascular business at Medtronic. “This new indication will provide physicians with enhanced device options when treating complex iliac artery disease.”