Irish medical technology firm Medtronic has obtained approval from the US Food and Drug Administration (FDA) for its Protégé GPS self-expanding peripheral stent system.
The approval has been granted for the stent system to treat stenotic lesions of the common and external iliac arteries.
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."
The approval was based on the nine-month results of the Durability Iliac study, which showed the safety and effectiveness of the stent system to treat stenotic lesions of the common and external iliac arteries.
According to the company, the multi-center and non-randomized clinical trial demonstrated 95.8% nine-month primary patency by Kaplan-Meier analysis and 98.6% freedom from target vessel revascularization.
The stent 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 said to cut from a nitinol tube into an open lattice design and includes tantalum radiopaque markers at the proximal and distal ends. It achieves predetermined diameter and exerts a constant and outward force to restore patency, upon deployment.
Image: Medtronic operational headquarters, Minneapolis. Photo: courtesy of Medtronic, Inc.