Medtronic, a healthcare products company based in Minneapolis, Minnesota, announced that it received CE Mark approval from the European Union for its self-expanding vascular stent. The Complete SE vascular stent is now cleared for use in arteries in the leg.
According to a press release by the company, the Complete SE self-expanding stent is designed for use with a patient’s proximal popliteal and superficial femoral arteries. The international launch of the device will begin immediately. The device is already cleared with the United States Food and Drug Administration for use in the iliac arteries, which supply blood to the legs and pelvis. An expanded indication for use in a patient’s lower extremities is currently under review by the U.S. watchdog agency.
Medtronic has experienced several other wins in the past few months. In early January, the company announced that it had successfully implanted the first Reveal insertable cardiac monitor in a qualified high-risk patient. In addition, the company received clearance from the FDA for its FlexCath Advance, a next-generation steerable sheath.
Professor Dierk Scheinert is the chairman of Part Hospital’s Center for Vascular Medicine in Leipzig, Germany. In prepared remarks, he said, “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.”
Note: Medtronic's innovation program manager, Craig Lauchner will be giving a talk titled "Assumption Storming: Disruptive innovations in medical devices" at the MD&M West event in February in Anaheim, CA.
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