Medtronic has announced the CE mark and international launch of its Complete SE self-expanding vascular stent for use in the lower extremities, specifically, the superficial femoral arteries and proximal popliteal arteries.
In the USA, the Complete SE stent has been approved by the US Food and Drug Administration (FDA) only for use in the iliac arteries. Its use in lower-extremities arteries in the USA is under review by the FDA. 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.
According to the company, the new indication was obtained after clinical data from the Complete SE SFA study—an independently adjudicated single-arm, multicentre trial that enrolled 196 patients at 28 sites in the USA and Europe—showed a low clinically-driven target lesion revascularisation (ie. repeat procedure) rate of 8.4% at 12 months. Additionally, and unique among similar studies utilising bare-metal stents in the vessel bed, there were no stent fractures at 12 months in the study. These outcomes were achieved despite the challenging nature of the patient population represented:
- 45% of the patients had diabetes.
- 50% of the lesions were located in the distal segment of the superficial femoral/proximal popliteal artery.
- 56% of the lesions were defined as highly calcified.
- 67% of patients had a Rutherford category rating of three or higher.
The Complete SE SFA study showed statistically significant improvements in multiple measures of clinical and functional effectiveness:
- More than 80% of study subjects had achieved a Rutherford category value of zero or one at 30 days, and that benefit persisted through six months and one 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 six and 12 months, with 65% of study subjects improving by at least 0.15% over the follow-up period.
- On walking assessment measures, impairment improved by 37%, distance by 33%, speed by 22% and stair climbing by 23%.
“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,” said Dierk Scheinert, chairman of the Center for Vascular Medicine at Part Hospital in Leipzig, Germany.