Peripheral artery disease interventions are definitely trending upwards as we’ve noted before. Now Medtronic, Inc. has announced the CE mark and international launch of its Complete SE (self-expanding) vascular stent for use in the lower extremities, specifically the superficial femoral arteries (SFA) and proximal popliteal arteries (PPA).
It’s another of those foibles of the differing global regulatory regimes that sees products indicated differently in different countries. Medtronic’s Complete SE stent is a case in point, where with this new approval European clinicians are able to use it for lower extremity lesions, while in the U.S. the FDA restricts it to the iliac arteries at the present time.
The new indication was obtained after clinical data from the Complete SE SFA study –– an independently adjudicated single-arm, multicentre trial that enrolled 196 patients at 28 sites in the United States and Europe –– showed a low clinically-driven target lesion revascularisation rate of 8.4 percent at 12 months. Additionally, and unique among similar studies utilizing bare-metal stents in this vessel bed, there were no (0.0 percent) stent fractures at 12 months in the study.
Medtronic says these outcomes were achieved despite the challenging nature of the patient population represented, 45% of whom had diabetes. 50 percent of the lesions were located in the distal segment of the superficial femoral /proximal popliteal artery. 56 percent of the lesions were defined as highly calcified. 67 percent of patients had a Rutherford Category rating of three or higher.
The Complete SE SFA study showed statistically significant improvements in multiple measures of clinical and functional effectiveness:
More than 80 percent 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.
Treatment with the Complete SE stent also resulted in highly significant positive shifts in mean ankle brachial index (ABI) or toe brachial index (TBI) scores at six and 12 months, with 65 percent of study subjects improving by at least 0.15 percent over the follow-up period.
On Walking Assessment measures, impairment improved by 37 percent, distance by 33 percent, speed by 22 percent and stair climbing by 23 percent.
“The Complete SE stent not only delivers compelling clinical results, but its unique features and delivery system offer an ease-of-use unparalleled with other devices designed to treat lower-extremity lesions,” said Prof. Dierk Scheinert, chairman of the Center for Vascular Medicine at Part Hospital in Leipzig, Germany.
Source: Medtronic, Inc.