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FDA approves peripheral stent system for iliac disease
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The EverFlex self-expanding peripheral stent system has received FDA approval for the treatment of atherosclerosis in the iliac arteries.
The new indication for the EverFlex stent (ev3 Inc./Covidien) includes improving luminal diameter in patients with atherosclerotic disease in the common and/or external iliac arteries ≤100 mm in length, with a reference vessel diameter of 4.5 mm to 7.5 mm, according to the FDA approval letter.
The nitinol stent can be delivered via a 6F catheter, and features a spiral-cell connection and peak-to-peak connection nodes that disperse force uniformly, along with a three-wave peak design that resists compression and enhances apposition, according to the manufacturer’s website. The flexible stent is intended to improve fracture resistance and restore vessel patency.
The approval follows results from the DURABILITY Iliac study, in which investigators from 13 US and two European sites enrolled 75 patients with stenotic, restenotic or occluded lesions of the common and/or external iliac arteries. The rate of major adverse events at 9 months, the primary outcome of the trial, was 0% among patients implanted with the EverFlex stent.
Since March 2012, the EverFlex stent has been commercially available in the US for use in the superficial femoral and proximal popliteal arteries.