Medtech titan Medtronic (NYSE:MDT) won new European regulatory consideration for its Complete SE vascular stent, gaining approval for use in the arteries that supply blood to the legs.
Medtronic won CE Mark approval in the European Union for use of the Complete SE self-expanding stent in the superficial femoral arteries and proximal popliteal arteries and announced international launch immediately.
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. Expanded indication for the lower extremities is currently under review by the FDA, according to a press release.
The news marks a series of wins for Medtronic, which earlier this month announced the 1st implant of its Reveal insertable cardiac monitor for atrial fibrillation in high-risk patients and touted FDA clearance and commercial launch for its next-generation FlexCath Advance steerable sheath.