Medtronic Announces Two New Trials To Expand TAVR Indications

The SMART trial will compare Medtronic’s Evolut TAVR systems to Edward’s Sapien 3 devices. Evolut EXPAND TAVR I will evaluate Evolut in patients with symptomatic moderate aortic stenosis or asymptomatic severe disease.

Medtronic Evolut-PRO 29mm
Medtronic's Evolut PRO transcatheter aortic valve • Source: Medtronic

Medtronic is sponsoring the SMART randomized head-to-head trial comparing its Evolut PRO and Evolut PRO+ self-expanding transcatheter aortic valve replacement systems against Edwards Lifesciences’ Sapien 3 and Sapien 3 Ultra balloon-expandable TAVR systems in patients with severe symptomatic aortic stenosis.

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