Dr. Leipsic is a consultant to Edwards Lifesciences; and provides computed tomography core laboratory services for Edwards Lifesciences, Medtronic, Neovasc, and Tendyne Holdings, for which no direct compensation is received. Sellers is supported by a fellowship from the Michael Smith Foundation for Health Research and the Canadian Institutes of Health Research. Some are essential to make our site work; others help us improve the user experience. Dr. Blanke is a consultant to Edwards Lifesciences. By using the site, you consent to the placement of these cookies. All rights reserved. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Dr. Within both the Trifecta and Mitroflow valves, implantation of the J-Valve and JenaValve resulted in retraction of the surgical valve leaflets, and placement of the Evolut Pro and SAPIEN 3 resulted in tubular expansion of the surgical valve leaflets. Frame Height: 49 mm Skirt Length: 12 mm 31 mm 23 mm 44 mm CoreValve 31mm . The CoreValve Evolut R and CoreValve Evolut PRO TAVs are used in patients whose own aortic heart valve is diseased due to calcium build up, which … CoreValve™ Bioprosthesis. Alternatively, the use of a THV that retracts the bioprosthetic leaflet away from the coronary ostium may prevent coronary obstruction. Download : Download high-res image (85KB)Download : Download full-size image. https://doi.org/10.1016/j.jcin.2019.10.021. The Evolut R valve design promotes single-digit gradients and large effective orifice areas (EOAs): The supra-annular valve optimizes coaptation in noncircular anatomy with supra-annular valve position and conforms to the native annulus. Evolut R 2.0: Evolut R - Original Evoluts + 34-mm Evolut R: Evolut R + 31-mm CoreValve Classic CoreValve Classic : Reference: Kasel AM, Cassese S, Bleiziffer S, Amaki M, Hahn RT, Kastrati A, Sengupta PP. 31 mm . For Evolut Platform valve sizing always refer to the IFU. Medtronic Hancock ™ Modified Orifice (M.O.) JACC Cardiovasc Imaging. 1. MEDICAL EDUCATION ACADEMIA The Enveo R Delivery System with 14Fr-Equivalent In-Line Sheath is indicated for vessels down to 5.0 mm Evolut R DCS 12 CoreValve and Evolut R Systems Overview | Medtronic - … Dr. Webb is a consultant to and has received research funding from Edwards Lifesciences, Abbott Vascular, Boston Scientific, and Vivitro Medical. Outflow cone 5. ViV implantation with new-generation THVs that directly interact with bioprosthetic valve leaflets results in surgical valve leaflet retraction. Copyright © 2020 Elsevier B.V. or its licensors or contributors. These devices are supplied sterile for single use only. For Evolut Platform valve sizing always refer to the IFU. MCS-P3-26-AOA . 1C), Sapien 3 IFU (10001354006 A) Area values for reference only. Standardized imaging for aortic annular sizing: implications for transcatheter valve selection. EnVeo™ PRO LS (Models L-ENVPRO-14-US and L-ENVPRO-16-US) and the EnVeo™ R LS (Models LS-ENVEOR23US, LS-ENVEOR2629US, and LS-ENVEOR-34-US). Loading System. 1C), Sapien 3 IFU (10001354006 A) Area values for reference only. We use cookies to help provide and enhance our service and tailor content and ads. The Evolut PRO+ system is the next-generation, self-expanding transcatheter aortic valve providing industry-leading hemodynamics. Locking collar . Valve Chart. 20 mm–23 mm ≤40 mm. High-resolution photography was used to assess the effect of the respective THVs on the bioprosthetic valve leaflets. This might mitigate the risk for coronary obstruction in selected cases of ViV transcatheter aortic valve replacement and also facilitate coronary reaccess after ViV TAVR. Coronary obstruction is a potentially devastating complication during valve-in-valve (ViV) transcatheter aortic valve replacement. VALVE SIZING Note: Measurements provided are approximate based on engineering specifications. SIzINg COMpARISONS EVOluT™ TAV vs. SApIEN™* 3 TAV Sources: Evolut PRO IFU (M970312A001 Rev. MCS-P3-29-AOA . VALVE SIZING Note: Measurements provided are approximate based on engineering specifications. Published by Elsevier. Dr. Cheung is a consultant to Abbott Vascular, Medtronic, and Neovasc. Imaging. See how the external tissue wrap on the Evolut PRO TAV performs. Valve Sizing Valve sizing should follow the IFU sizing chart Procedural Steps Once the appropriate patient and valve are selected, the procedure is divided into five sequential steps – access, valve crossing, balloon aortic valvuloplasty … 1. Inflow cone 3. 3The second generation Evolut R and the third generation Evolut Pro have showed improved outcomes over the first generation valve. MCS-P3-31-AOA . CoreValve™ Evolut™ R System . 1.2 Delivery Catheter System (Catheter) The catheter with AccuTrak™ stability layer is compatible with a 0.035-in (0.889-mm) … By continuing you agree to the use of cookies. … The Evolut PRO system design has one important addition — an external tissue wrap is added around the outer sealing zone of the nitinol frame which, combined with the platform design, provides advanced sealing. Backplate 4. MEDICAL EDUCATION ACADEMIA The Enveo R Delivery System with 14Fr-Equivalent In-Line Sheath is indicated for vessels down to 5.0 mm Evolut R DCS 12 CoreValve and Evolut R … Dr. Wood is a consultant to Edwards Lifesciences. Catheter tip guide tube 2. A 25-mm J-Valve, a 26-mm Evolut Pro, and a 23-mm JenaValve were implanted into both a 25-mm Trifecta surgical valve and a 25-mm Mitroflow surgical valve. The aim of this study was to examine the effect of different transcatheter heart valves (THVs) on valve leaflet displacement when deployed within bioprosthetic surgical valves and, thereby, risk for coronary obstruction. 250 Valve3 Surgical Valve Size 19 mm 21 mm 23 mm 25 mm 27 mm 29 mm 31 mm Inner Diameter † 16 18 20 21.8 - - - Height 17 18.5 19.5 21.25 - - - Medtronic Hancock™ Standard Valve4 Surgical Valve Size 19 mm 21 mm 23 mm 25 mm 27 mm 29 mm 31 mm Inner Diameter † - - 20 21.8 22.3 24.1 … 23 mm . Delivery Catheter System . Close Cookie Statement. 26 mm–29 mm ≤43 mm. ScienceDirect ® is a registered trademark of Elsevier B.V. ScienceDirect ® is a registered trademark of Elsevier B.V. Focus on Valve-in-Valve TAVR and Coronary Access, Bioprosthetic Valve Leaflet Displacement During Valve-in-Valve Intervention. The new Evolut R 34mm valve is approved for severe aortic stenosis patients who are at high or extreme risk for surgery with an annulus size ranging from 26mm to 30mm. This large valve segment is estimated to account for approximately 25–30% of the eligible global TAVI patient population. © 2020 the American College of Cardiology Foundation. 23 mm–26 mm ≤43 mm. The commercial name of the Evolut™ PRO device is Medtronic CoreValve ™ Evolut PRO System. This site uses cookies to store information on your computer. Control and Access. Dr. Sathananthan has received speaking fees from and is a consultant to Edwards Lifesciences. Capsule guide tube 6. Caution: Implantation of the Medtronic CoreValve™ Evolut™ R system should be performed only by physicians who have received Medtronic CoreValve™ Evolut™ R training. Dr. Ye is a consultant to Edwards Lifesciences and JC Medical. MCS-P4-23-AOA . There were significant differences in displacement angles and distances between both the J-Valve and JenaValve and the SAPIEN 3 and Evolut Pro (p < 0.0001). A 23-mm and a 26-mm SAPIEN 3 were deployed into the Trifecta and Mitroflow, respectively. 29 mm . Figure 9: EnVeo™ PRO LS . Frame Height: 49 mm Skirt Length: 12 mm 31 mm 23 mm 44 mm CoreValve 31mm . Displacement of the surgical valve leaflets (retraction vs. expansion) was measured with implantation of each THV by measuring displacement angle and maximal displacement distance. 26 mm . The Evolut R system is built on the CoreValve platform including … 2013 Feb;6(2):249-62. Strategies such as provisional stenting and intentional bioprosthetic valve leaflet laceration have been developed to mitigate this risk. 18 mm–20 mm ≤34 mm. … CoreValve™ Evolut™ R Transcatheter Aortic Valve . SEE THE EVOLUT PRO SYSTEM EVOLUT R SYSTEM . 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. Features of the EnVeo TM PRO delivery system allow you to treat more patients and position the valve more accurately. Alert Indications, Safety, and Warnings. The commercial name of the Evolut™ PRO device is Medtronic CoreValve ™ Evolut PRO System. Medtronic CoreValve System; Medtronic CoreValve Evolut R System; Medtronic CoreValve Evolut PRO System - P130021/S033. SIzINg COMpARISONS EVOluT™ TAV vs. SApIEN™* 3 TAV Sources: Evolut PRO IFU (M970312A001 Rev. Figure 10: EnVeo™ R LS . CoreValve™ Evolut™ Bioprosthesis . 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.
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