Medtronic has received CE Mark and initiated an international launch of its Complete SE (self-expanding) vascular stent for use in the lower extremities, specifically, the superficial femoral arteries (SFA) and proximal popliteal arteries.
The Complete SE stent has been approved by the FDA only for use in the iliac arteries. Its use in lower-extremity arteries in the U.S. is under review by the FDA, according to Minneapolis-based Medtronic. Previously CE Marked only for use in the iliac arteries, the Complete SE stent can now be used internationally in the lower extremities as well.
The new indication was obtained after clinical data from the Complete SE SFA study, an independently adjudicated single-arm, multicenter trial that enrolled 196 patients at 28 sites in the U.S. and Europe.