Medtronic has reported the one-year results from an international study of the Complete self-expanding (SE) vascular stent, designed for the treatment of atherosclerosis in the superficial femoral artery (SFA).
The prospective single-arm Complete SE SFA study included 196 subjects with a total of 213 lesions at 28 sites in the US and Europe.
The US Food and Drug Administration (FDA) approved study investigated the safety and efficacy of the Complete SE stent in treating lesions of the SFA and proximal popliteal artery (PPA).
At the 12 month follow-up period, the trial evaluated primary endpoints such as major adverse events for safety and primary patency for efficacy.
Treatment with the Complete SE stent resulted in positive shifts in mean ABI/TBI scores at six and 12 months, with more than 60% of subjects improving by at least 0.15 over the follow-up period.
The study also showed that more than 80% of subjects attained a Rutherford Category value of 0 or 1, the favourable end of the 0-6 scale, at 30 days, which was maintained through six months and one year of follow-up.
The walking assessment measures reported 36.8% improvement in impairment, while distance improved by 32.4%, speed by 21.8% and stair climbing by 23.3%.
Earlier studies showed that the Complete SE demonstrated a primary patency rate of 73.1%, a major adverse event rate of 11% and a target lesion revascularisation (TLR) rate of 9.4% at 12 months of patient follow-up.
One of the principal investigators of the study, Dr John Laird of UC Davis Medical Center, said: "The investigators found the device easy to use in treating SFA lesions of varying complexity, which is indicative of clinical practice."
Medtronic Endovascular Therapies business vice president and general manager Tony Semedo said the Complete SE SFA study was indicative of the company’s commitment to building the clinical evidence necessary to advance peripheral interventional therapies.
Medtronic provides variety of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias.