The self-expanding stent, which features a delivery system, expands the interior diameter of narrowed peripheral arteries and restores normal blood flow.
The approval is based on the positive results of adjudicated single-arm, multicenter 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% 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 favorable 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.
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 utilizing bare-metal stents in the vessel bed, also showed 0.0% stent fractures at 12 months, claims Medtronic.
The company said the Complete SE stent is currently available for use in the iliac arteries in the US, while it is under review by the FDA for use in lower-extremity arteries.
