Medtronic, a US-based manufacturer of implantable heart-rhythm devices, has obtained the US Food and Drug Administration (FDA) approval for the Complete SE (self-expanding) vascular stent for use in superficial femoral artery (SFA) and proximal popliteal artery (PPA), which carry blood through the upper legs.
The FDA approval of Complete SE for the new SFA and PPA indications is based on the results from the Complete SE SFA study, which demonstrated a clinically-driven target lesion revascularization (repeat procedure) rate of 8.4%, total major adverse events rate of 11%, no in-hospital major adverse events and no stent fractures at 12 months.
The Kaplan-Meier estimate of primary patency was 90.9% at 360 days; and the primary patency was 72.5% at the time of the last duplex ultrasound assessment at 553 days.
A total of 196 patients have been enrolled at 28 sites in the US and Europe in the Complete SE SFA study.
UC Davis Vascular Center near Sacramento medical director and primary investigator Dr John Laird noted the Complete SE vascular stent has demonstrated compelling clinical results in this study, which included a broad spectrum of patient and lesion types
"It is also among the most deliverable and easy-to-use devices of its kind," Dr Laird added.
Earlier, the Complete SE obtained FDA approval for use in the iliac arteries, which perfuse the pelvis, and the device also obtained CE Mark approval for both iliac, and SFA and PPA indications.