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Tavi Platforms Evidence Update
CoreValve™ and Evolut™ TAVI systems are the only platforms to demonstrate a durability benefit over SAVR at 5 years1,2.
Significantly lower rate of SVD with TAVI vs Surgery through 5 years in small annuli2. This difference in SVD was more profound in patients with smaller ( ≤23 mm) annuli (5.86% surgery vs 1.39% TAVI; P=0.049)2, but a trend was also found in patients with larger ( >23 mm) annuli (3.96% surgery vs 2.48% TAVI; P=0.067)2.
Corevalve Evolut Pooled Analysis
5-Year SVD In Smaller (≤23 mm) Annular Diameters2
In pooled analysis of intermediate and high-risk patients. Devices used: Corevalve 88.5%, Evolut R 11.5%.
Reardon M. 5-Year Incidence, Timing and Predictors of Structural Valve Deterioration of Transcatheter and Surgical Aortic Bioprosthesis: Insights from the CoreValve US Pivotal and SURTAVI Trials. Presented at ACC 2022.
Structural Valve Deterioration (SVD) was defined as an increase in mean gradient ≥10 mm Hg from discharge/30-day echo to last available echo AND mean gradient ≥20 mm Hg at last available echo OR new onset/increase of intra-prosthetic aortic regurgitation (AR) ≥ moderate.
DISCLAIMER:
See the CoreValve™ Evolut™ R, the CoreValve™ Evolut™ PRO and the Evolut™ PRO+ device manuals for detailed information regarding the instructions for use, the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events.
For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu. For applicable products, consult instructions for use on manuals.medtronic.com. Manuals can be viewed using a current version of any major internet browser. For best results, use Adobe Acrobat© Reader with the browser.
The commercial name of the Evolut™ R device is Medtronic CoreValve™ Evolut™ R System, the commercial name of the Evolut™ PRO device is Medtronic CoreValve™ Evolut™ PRO System, and the commercial name of the Evolut™ PRO+ device is Medtronic Evolut™ PRO+ System.
Medtronic and the Medtronic logo are trademarks of Medtronic. ™*Third party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company.