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Medtronic Canada Receives Expanded Indication From Health Canada For Evolut TAVI Platform

Medtronic Canada ULC, a unit of Medtronic plc (MDT), has received a new expanded indication from Health Canada for Evolut Transcatheter Aortic Valve Implantation system. The company noted that its TAVI platform is currently the only system licensed for both bicuspid aortic valves, as well as all surgical risk categories in Canada. The expanded indication also allows patients with bicuspid aortic valves at extreme, high and intermediate risk of surgical mortality to also receive the procedure.

The expanded indication was based on clinical data from the global, randomized, multi-center Evolut Low Risk Trial, which evaluated three valve generations against surgical valve replacement in more than 1,400 patients.

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