ACC 2020: Medtronic’s Evolut TAVR Works In Low-Risk Bicuspid Study
Early results from the Low-Risk Bicuspid study of the Evolut transcatheter aortic valve replacement system showed low rates of all-cause mortality or stroke.
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Medtronic’s revenue of $6.5bn in the first quarter of fiscal 2021 represents a 17% fall year-over-year, but it still beat analysts’ projections.
The two-year results from the PARTNER 3 trial showed transcatheter aortic valve replacement with Edwards Lifesciences' Sapien 3 system was statistically non-inferior to surgical valve replacement in low-risk patients. The one-year results from the trial had shown TAVR was superior to surgery in low-risk patients.
As expected, the US FDA has expanded the approved indication for four transcatheter aortic valves – Edwards Lifescience’s Sapien 3 and Sapien 3 Ultra, and Medtronic’s CoreValve Evolut R and CoreValve Evolut PRO – to include patients at low risk for complications during surgery.