The global medical device giant said 3-year results from the Durability II study of Everflex showed the single-stent treatment had sustained effect in addressing long, complex lesions in the superficial femoral and popliteal arteries and keeping them unobstructed.
Durability II is a multi-center non-randomized single-arm study that enrolled 287 patients at 44 centers in the U.S. and Europe. EverFlex is a nitinol stent system that expands and reopens the superficial femoral and popliteal arteries to address blockages.
"In the Durability II study, the use of a single long [EverFlex] stent demonstrated the ability to achieve long-term vessel [openings], while minimizing the need for re-interventions," aortic & peripheral vascular medical director Dr. Mark Turco said in prepared remarks.
Everflex won CE Mark approval in the European Union back in 2013, a year after FDA officials signed off on the device.