Medtronic announces that the US Food and Drug Administration (FDA) has approved the Complete SE (self-expanding) vascular stent for use in the lower extremities, specifically in the superficial femoral artery and proximal popliteal artery.
The same device was originally approved by the FDA for use in the iliac arteries. It also has the CE mark for iliac and, most recently, for superficial femoral and and proximal popliteal indications.
FDA approval of the stent was supported by the results of the Complete SE SFA study—an independently adjudicated single-arm, multicentre trial that enrolled 196 patients at 28 sites in the USA and Europe. The study shows a clinically-driven target lesion revascularization (repeat procedure) rate of 8.4% at 12 months, which is among the best performances in clinical trials of contemporary self-expanding peripheral stents for the treatment of superficial femoral and proximal popliteal arterylesions, according to Medtronic.
Additionally, there were no in-hospital major adverse events among study patients, and the total adverse event rate at 12 months was 11%. The Kaplan-Meier estimate of primary patency at 360 days was 90.9%; at the time of the last duplex ultrasound assessment, at 553 days, primary patency was 72.5%. No stent fractures occurred through to 12 months.
The study also shows statistically significant improvements in multiple measures of clinical and functional effectiveness:
- More than 80% of the patients had achieved a Rutherford classification of 0 or 1, the favourable end of the 0–6 scale, at 30 days, and that benefit persisted through six months and one year of follow-up.
- On walking assessment measures at 12 months, absolute improvement in impairment was 37%, distance was 32%, speed was 22% and stair climbing was 23%.
- 65% of the patients showed an improvement of 0.15 or more on their ankle-brachial index or toe-brachial index scores over the 12-month follow-up period. The mean ankle-brachial/toe-brachial index score at 12 months was 0.9.
These outcomes were achieved despite the challenging nature of the patient population:
- 45% of the patients had diabetes, and 67% had a Rutherford classification of 3 or higher at baseline.
- 50% of the treated lesions were located in the distal segment of the artery, and 91% were moderately or highly calcified.
“The Complete SE vascular stent demonstrates compelling clinical results in this study, which included a broad spectrum of patient and lesion types,” said primary investigator John Laird, medical director of the UC Davis Vascular Center, USA “It is also among the most deliverable and easy-to-use devices of its kind.”
