Medtronic received FDA clearance to introduce the company’s Complete SE stenting system for use within the superficial femoral and proximal popliteal arteries of the legs. The self expanding stent earlier received approval for use within the iliac arteries, and the same approvals already exist in Europe.
The system features a triaxial design that uses an inner shaft, a retractable sheath and a stabilising sheath together to improve ease and accuracy of deployment.
From the announcement:
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.
Additionally, there were no in-hospital major adverse events (MAE) among study patients, and the total MAE rate at 12 months was 11.0 percent. The Kaplan-Meier estimate of primary patency at 360 days was 90.9 percent; at the time of the last duplex ultrasound assessment, at 553 days, primary patency was 72.5 percent. No stent fractures occurred through 12 months.
Product page: Complete™ SE Self-Expanding Vascular Stent System…