TCT 2019: One-Year PARTNER 3 Outcomes Show Better Quality Of Life With TAVR
An analysis of the PARTNER 3 trial shows transcatheter aortic replacement with Edwards Sapien 3 yields better health status outcomes than surgical valve replacement after one year.
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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.
Sales of Sapien transcatheter aortic valves grew about 27% year over year in the third quarter of 2019 while revenues from Edwards’ transcatheter mitral and tricuspid therapies grew to almost $10m, led by sales of the Pascal transcatheter mitral repair system in Europe.
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.