Medtronic Reports FDA Approval for Complete SE Vascular Stent

Expanding its role in the treatment of peripheral artery disease in the United States, Medtronic, Inc. MDT announced today that the U.S. Food and Drug Administration (FDA) has approved the Complete SE (self-expanding) vascular stent for use in the lower extremities -- specifically, the superficial femoral artery (SFA) and proximal popliteal artery (PPA), which carry blood through the upper legs. The same device was originally approved by the FDA for use in the iliac arteries, which perfuse the pelvis. It also has the CE (Conformité Européene) mark for iliac and, most recently, for SFA and PPA indications. FDA approval of the new SFA and PPA indications was supported by the results of the Complete SE SFA study -- an independently adjudicated single-arm, multicenter trial that enrolled 196 patients at 28 sites in the United States and Europe. The study showed a clinically-driven target lesion revascularization (repeat procedure) rate of 8.4 percent at 12 months, which is among the best performances in clinical trials of contemporary self-expanding peripheral stents for the treatment of SFA/PPA lesions. See full press release