The US Food and Drug Administration (FDA) has granted approval for Irish medical technology firm Medtronic‘s Protégé GPS self-expanding peripheral stent system to treat stenotic lesions of the common and external iliac arteries.
Iliac stenosis occurs when plaque builds up in the iliac artery, which can block blood supply to the entire leg causing pain and eventually leading to reduced mobility.
Approval was based on the nine-month results from a prospective, multi-centre, non-randomised Durability Iliac study, which showed the safety and effectiveness of the stent system in the treatment of stenotic lesions of the common and external iliac arteries.
The trial showed 95.8% nine-month primary patency by Kaplan-Meier analysis and 98.6% freedom from target vessel revascularisation.
Mount Sinai School of Medicine co-national principal investigator of the Durability Iliac study Dr Peter Faries said: "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."
The system helps physicians to treat iliac artery lesions and restore blood flow with large diameter stents through a low and 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.
Following deployment, the stent achieves its predetermined diameter and exerts a constant, outward force to restore patency.
Medtronic aortic and peripheral vascular business medical director Dr Mark Turco said: "The Protégé GPS self-expanding peripheral stent system is designed to enhance delivery, deployment and visibility during peripheral vascular procedures.
"This new indication will provide physicians with enhanced device options when treating complex iliac artery disease."