Medtronic's Complete SE Stent Gains CE Mark Approval for Lower Extremity Indication

January 24, 2013—Medtronic, Inc. (Minneapolis, MN) announced that its Complete SE (self-expanding) vascular stent has received CE Mark approval for use in the lower extremities—specifically, the superficial femoral artery (SFA) and proximal popliteal artery (PPA). Medtronic is commencing an immediate international launch of the device for this indication. Complete SE previously received CE Mark approval for use in the iliac arteries.

In the United States, the Complete SE stent is only approved for use in the iliac arteries. The US Food and Drug Administration is reviewing the device for use in the lower extremity arteries.

“The Complete SE stent not only delivers compelling clinical results, but its unique features and delivery system offer an ease of use unparalleled with other devices designed to treat lower extremity lesions,” commented Prof. Dierk Scheinert, MD, in Medtronic's press release. Prof. Scheinert is Chairman of the Center for Vascular Medicine at Park Hospital in Leipzig, Germany.

According to Medtronic's press release, the lower extremity indication was approved 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 United States and Europe—showed a low clinically driven target lesion revascularization rate of 8.4% at 12 months. Additionally, there were no stent fractures at 12 months in the study.

Furthermore, these outcomes were achieved within a challenging study population: 45% of the patients had diabetes, 50% of the lesions were located in the distal segment of the SFA/PPA, 56% of the lesions were defined as highly calcified, and 67% of patients were Rutherford category 3 or higher.

The Complete SE SFA study showed statistically significant improvements in multiple measures of clinical and functional effectiveness. More than 80% of patients improved to Rutherford category 0 or 1 at 30 days, and that benefit persisted through 6 months and 1 year of follow-up. Treatment with the Complete SE stent also resulted in highly significant positive shifts in mean ankle-brachial index or toe-brachial index scores at 6 and 12 months, with 65% of patients improving by at least 0.15% during the follow-up period. On Walking Assessment measures, impairment improved by 37%, distance by 33%, speed by 22%, and stair climbing by 23%, advised Medtronic.