Changes in label for Medtronic - results compared to AVR

“The increased adoption of the Evolut platform globally is partially attributed to the fact that it meets the needs of a broad variety of patients including those who have unique anatomical variations,” said Jeffrey Popma, M.D., chief medical officer and vice president, medical affairs for the Structural Heart business, which is part of the Cardiac and Vascular Group at Medtronic.

The revised labeling is supported by recent data from the Low Risk Bicuspid Study, which showed bicuspid patients implanted with Evolut TAVR had low rates of all-cause mortality or disabling stroke at 30 days (1.3%), a low rate of serious procedural complications, no annular ruptures or aortic dissections and no moderate/severe paravalvular leak.

The study also maintained the Evolut TAVR platform’s industry-leading hemodynamics (blood flow) with patients experiencing low mean AV gradients (7.6 ± 3.7 mm Hg), and large effective orifice area (2.3 ± 0.7 cm2).

Just a reminder of AVR’ hemodynamic results to date - note far superior to the industry leading results that Medtronic currently get (and remember Popma is on our Ad Board and loves DurAVR)