CoreValve Evolut R TAVI system has received CE approval to expand the indication to include patients who are at high or greater risk for surgical aortic valve replacement OR are ≥75 years of age and at intermediate risk for surgical AVR (Society of Thoracic Surgeons operative risk score ≥4% or with an estimated hospital mortality ≥4% as assessed by the heart team).
As presented at the ACC 2016 annual meeting, the CoreValve self-expanding, supra-annular valve continues to show a lower rate of stroke or mortality vs surgery, with better hemodynamic performance.
Two year outcomes comparing TAVI with CoreValve to surgical aortic valve replacement (SAVR) in high risk patients was presented in a late-breaking session at ACC.15. As the first major TAVI trial to demonstrate superiority vs. SAVR, the findings show that the clinical advantages of TAVI with CoreValve are maintained over time.
The results presented in a late breaking first reports session at TCT 2014 demonstrate the CoreValve system delivers high survival, a low and stable stroke rate and sustained hemodynamic and paravalvular leak performance in an extremely complex and frail patient population out to two years.
Results were presented in a late breaking clinical trial session at ACC.14 with simultaneous publication in the New England Journal of Medicine. Results demonstrate how the CoreValve design delivers performance that matters most to both physicians and their patients.
The results demonstrate how the CoreValve design achieves high survival rates and low rates of stroke and paravalvular leakage in complex and frail patients.
CoreValve and CoreValve Evolut—the first and only TAVI devices to receive an indication for use in degenerative surgical bioprostheses—now provide options for patients at high operative risk for redo surgery.
New data presented at EuroPCR 2013 shows favorable 1 year outcomes with high survival rates, low and stable rates of stroke, and significant and sustained hemodynamic improvement.