It provides the optional capability of allowing for resheathing and/or complete recapture and redeployment during valve deployment. CoreValve™ Evolut™ R System . Fluoroscopic images depicting deployment of a 26 mm Evolut Pro valve are shown here. Multi-detector computed tomography analyses indicate good commissural alignment. Watch this session if you want to understand how the Evolut PRO and Acurate Neo 2 devices deploy in a dedicated simulator, to learn the deployment steps of these devices and to experience how these devices deploy from a unique perspective. Once The CoreValve Evolut R and CoreValve Evolut PRO TAVs can improve blood flow in patients with aortic stenosis. The Evolut R TAV is fully functional at approximately 2/3 partial deployment from the DCS. Methods: THVs of varying design (Sapien 3, Evolut Pro, Acurate neo, Allegra, and Portico) and sizes were implanted inside Sapien XT and Evolut R THVs. Changing Mindset to Focus on the Future The indication has also since been expanded in Panel Track PMA Supplements Objectives: This study sought to compare outcomes following transcatheter aortic valve replacement when valve repositioning was performed (repositioned group) versus procedures without repositioning (nonrepositioned group). Imaging High-resolution photography was used to assess the effect of the respective THVs on the bioprosthetic valve leaflets. Background: The Evolut R and Evolut PRO valves were designed to allow repositioning during deployment, yet the effect of repositioning on clinical outcomes remains unclear. CoreValve™ Evolut™ R Transcatheter Aortic Valve . In the clinical study, the two … The Evolut Pro and SAPIEN 3 valves were not implanted at different depths, as there would not be any change expected on surgical valve leaflet displacement. 60 day porcine research study model, courtesyofMEDTRONIC Watch this session if you want to learn how to cross a stenosed aortic valve quickly and successfully every time and to appreciate how optimal aortic annular projection influences transcatheter heart valve deployment. This session was originally … Evolut PRO explanted from Porcine Model at 60 Days, Cross Section between Nodes 1 and 2, example picture from MDT research study on file 1. ... guidewire. One study will pit the self-expanding Evolut Pro and Pro+TAVR systems against Edwards Lifesciences Corp.’s balloon-expandable Sapien 3 and Sapien 3 Ultra transcatheter heart valves in small annulus patients. Note that the “Hat” marker is positioned anteriorly in the center of the deployment device (“center front”), with the C-tab seen at the inner curve of the ascending aorta. Medtronic plc has kicked off two clinical trials of its Evolut transcatheter aortic valve replacement (TAVR) system. The CoreValve Evolut R TAV, as shown in Figure 4, is a design iteration of the CoreValve TAV. Medtronic data on file. Delivery Catheter System . And while optimally positioning an Evolut R/PRO device during deployment can facilitate future coronary access, more than 23% of patients had severe overlap of one or more coronary arteries even when optimized with the hat marker in outer curve/center back position during deployment. Medtronic, data on file. Hydrodynamic function as per International Standard Organization (ISO) specifications was evaluated using a pulse … EVOLUT PRO CASE EXAMPLE VALVE DEPLOYMENT TO POINT OF NO RECAPTURE 31 Medtronic Evolut PRO In-service | Medtronic - Confidential Controlled, 1:1 Response with Ability to Recapture* *Able to recapture up to three times before reaching the point of no recapture; upon third recapture the system must be removed 90 day porcine GLP Evolut R study illustrating tissue interaction.2 2. Evolut R System was approved under P130021/S014 (for sizes 23, 26, and 29 mm) and P130021/S025 (for size 34 mm) on June 22, 2015, and October 26, 2016, respectively; and the Evolut PRO System was approved under P130021/S029 on March 20, 2017.
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