Medtronic can now market the Complete SE (self-expanding) stent for use in the superficial femoral artery and proximal popliteal artery, in addition to its previous indication for treatment in the iliac arteries that perfuse the pelvis.
The expanded approval was supported by results from Medtronic’s Complete SE SFA study, a single-arm trial of nearly 200 patients at 28 sites in the U.S. and Europe, that found a 8.4% repeat procedure rate at 1 year, which Medtronic says is "among the best performances in clinical trials of contemporary self-expanding peripheral stents for the treatment of SFA/PPA lesions."
The treatment proved itself successful and safe despite a challenging patient population, including patients with diabetes and those with lesions in hard-to-reach areas.
The Complete SE stent already had European as well as U.S. regulatory approval for treatment in the iliac arteries, which supply blood to the pelvis and legs. Medtronic also won extended European indication in January of this year.
MDT shares were pretty flat this afternoon, trading at a 0.2% increase of $53.84 as of about 12:10 p.m.