Medtronic has obtained the US Food and Drug Administration (FDA) approval to market its Complete SE (self-expanding) vascular stent, designed for use in lower extremities, including superficial femoral arteries (SFA) and proximal popliteal arteries (PPA).
Medtronic can now market the Complete SE stent for use in the SFA and PPA, in addition to its previous indication for treatment in the iliac arteries that perfuse the pelvis.
The Complete SE stent features a dual-deployment handle and a triaxial catheter, enabling clinicians with exceptional deployment accuracy, while also reducing unexpected stent jumping.
The stent’s triaxial design comprises an inner shaft, a retractable sheath and a stabilising sheath, which together reduces friction and force required for deployment thereby rendering the process easy and accurate.
FDA approval is based on positive results from the adjudicated single-arm, multicentre Complete SE SFA study, which enroled 196 patients at 28 sites in the US and Europe.
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 the benefit persisted through six months and one year of follow-up.
The results also demonstrated highly significant positive shifts in mean ankle brachial index (ABI) or toe brachial index (TBI) scores at six and one year, 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 study found an 8.4% repeat procedure rate at one year, which is a reportedly best performance among contemporary self-expanding peripheral stents for the treatment of SFA/PPA lesions in clinical trials.
Also, the study recorded no in-hospital major adverse events (MAE) among the participants with 11% total MAE rate at 12 months.
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 12 months.
UC Davis Vascular Center Sacramento medical director primary investigator Dr John Laird said: "It is among the most deliverable and easy-to-use device of its kind."
The Complete SE stent previously received European regulatory approval for treatment in the iliac arteries, and most recently, for SFA and PPA indications.
According to GlobalData estimates, peripheral vascular stents market in the US was valued at $515m in 2012 and is expected to grow at a CAGR of 3.5% to reach $654m by 2019.
Image: Medtronic HQ, Minneapolis, Minnesota, US. Photo: courtesy of Medtronic, Inc.