Forrestal BJ, Case BC, Yerasi C, Shea C, Torguson R, Zhang C, Ben-Dor I, Deksissa T, Ali S, Satler LF, Shults C, Weissman G, Wang JC, Khan JM, Waksman R, Rogers T. Risk of Coronary Obstruction and Feasibility of Coronary Access After Repeat Transcatheter Aortic Valve Replacement With the Self-Expanding Evolut Valve: A Computed Tomography Simulation Study. An implantable xenograft (e.g., bovine, porcine) intended to be used to repair/replace a stenosed or regurgitant aortic heart valve, or previously-implanted aortic heart valve prosthesis, and which is designed to be implanted with a catheter via transarterial access (e.g., femoral, subclavian, aortic) or transapical access while the heart is beating. For general information, Learn About Clinical Studies. This latest generation device features an outer wrap to improve annular sealing and reduce paravalvular leak. Find additional feature information, educational resources, and tools. The latest iteration of the self-expandable valve is Medtronic's repositionable valve known as the Evolut PRO system. The delivery system features a 1:1 response, thus providing immediate feedback between the deployment knob and the movement of the capsule. For subjects in the CT arm only, renal function precluding the administration of iodinated contrast for cardiac CT (eGFR < 30 ml/min/1.73m2). Heart. Transcatheter Aortic Heart Valves doi: 10.1161/CIRCINTERVENTIONS.120.009496. 60% 50%. Last month, Medtronic announced receipt of U.S. Food and Drug Administration (FDA) approval for and launch of the Evolut Pro+ TAVR (Transcatheter Aortic Valve Replacement) System to … The Evolut PRO valve also showed strong hemodynamic performance with large aortic valve areas (2.0 ± 0.5 cm 2) and mean gradients in the single digits (6.4 ± 2.1 mm Hg) at 30 days. Features of the EnVeoTM PRO delivery system allow you to treat more patients and position the valve more accurately. The supra-annular, self-expanding design of the Evolut PRO system provides a large effective orifice area (EOA). In 08/2017 one of the market leaders introduced its latest generation valve model -the CoreValve Evolut PRO TM – which was especially designed to mitigate paravalvular leakage after valve deployment. If you continue, you will leave this site and go to a site run by someone else. Access instructions for use and other technical manuals in the Medtronic Manual Library. Medtronic touted the newest version’s four valve … The self-expanding, repositionable, supra-annular valve has been designed with an outer porcine pericardial tissue wrap intended to … This study is a prospective registry of subjects with symptomatic severe aortic stenosis undergoing TAVR with a commercially-approved self-expanding transcatheter heart valve. Once in position, both the Evolut R and PRO valves were deployed in stepwise fashion including repositioning as needed. Information provided by (Responsible Party): The primary objective of this study is to evaluate the real-world performance of the CoreValve Evolut PRO transcatheter aortic valve, including leaflet function, in a prospective observational registry. The external tissue wrap on the Evolut PRO 100% valves has shown excellent PVL performance. Determine how the Evolut PRO conforms to LVOT calcification. Individual Participant Data (IPD) Sharing Statement: Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Product Manufactured in and Exported from the U.S.: Compare the rate of ≥mild PVL in patients with none/mild versus moderate/severe LVOT calcification. The frame oversizing and cell geometry provide consistent radial force across the treatable annulus range. The Evolut PRO valve (Medtronic), has the same repositioning features as its predecessor, the Evolut R valve, but with the addition of an outer porcine pericardial wrap with the intent to … The institutional Heart Team will select patients according to standard practice. ClinicalTrials.gov Identifier: NCT03423459, Observational You have reached the maximum number of saved studies (100). Fridley, Minn.-based Medtronic won CE Mark approval in the European Union for predecessor valve Evolut Pro in July 2017. The … August 2006;92(8);1022-1029. MOSAIC BIOPROSTHESIS | INDICATIONS: For the replacement of malfunctioning native or … Products 31.6 65.6. The head-to-head study, dubbed SMART post-market trial is planned to compare the valve safety and performance of Evolut PRO and PRO+TAVR Systems versus SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valves from Edwards Lifesciences. The Evolut PRO self-expanding transcatheter aortic valve features a unique valve design with an outer wrap that adds surface area contact between the valve and the native aortic annulus to further advance valve sealing performance. SMART Trial principal investigator and steering committee chair Howard C Herrmann said: “Hemodynamic performance is particularly important in … The Evolut PRO valve features an external tissue wrap added to the proven platform design. The Evolut™ PRO system combines exceptional valve design and advanced sealing with an excellent safety profile. Flameng, W, et al. Benefits of a large EOA may include: Supra-annular valve design maximizes leaflet coaptation and promotes single-digit gradients and large EOAs. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. The Evolut PRO system goes beyond the CoreValve™ and Evolut R systems' unique design: a supra-annular, self-expanding nitinol frame with a porcine pericardial tissue valve. Percentage of Available Echos (%) Evolut PRO. Medtronic Canada does not review or control the content on the other website, and is not responsible for any business dealings or transactions you have there. These legacy and new design features provide the following sealing mechanisms: The external wrap increases surface contact with native anatomy, providing advanced sealing.