The European Union has granted CE mark certification to Medtronic's self-expanding vascular stent for use in lower extremities, including superficial femoral arteries (SFA) and proximal popliteal arteries (PPA), which supply blood to the legs.
Featuring a delivery system, the Complete SE stent expands the interior diameter of narrowed peripheral arteries and restores normal blood flow.
The approval is based on positive results from the adjudicated single-arm, multicentre Complete SE SFA study, which enrolled 196 patients in which 45% were diabetic, 50% had lesions in the distal segment of the SFA/PPA, 56% of the lesions were defined as highly calcified and 67% of them had a Rutherford Category rating of three or higher.
The results demonstrated that more than 80% of study subjects had achieved a Rutherford Category value 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.
Results also demonstrated highly significant positive shifts in mean ankle brachial index (ABI) or toe brachial index (TBI) scores at six and 12 months, with 65% of study subjects improving by at least 0.15% over the follow-up period, according to the company.
In addition, on walking assessment measures, patients' impairment was improved by 37%, distance by 33%, speed by 22% and stair climbing by 23%.
The Complete SE study, when compared to similar studies utilising bare-metal stents in the vessel bed, also showed 0.0% stent fractures at 12 months.
In the US, the Complete SE stent is currently available for use in the iliac arteries, which supply blood to the pelvis and legs.
Medtronic said the use of the Complete SE stent in lower-extremity arteries in the US is under review by the FDA.
Image: Medtronic corporate headquarters in Fridley, Minnesota, US. Photo: Courtesy of Bobak Ha'Eri.