Evolut PRO+ is the latest generation TAVR system which launched in the U.S. in September 2019. In addition, 4 THVs, Evolut PRO, Edwards Centera, SAPIEN 3 Ultra and Myval, received CE mark approval in 2017, 2018, 2018 and 2019 respectively. 547 28 endobj ACURATE neo (NEO) and Evolut PRO (PRO). Talent Thoracic Stent Graft product brochure. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates. Evolut PRO per the baseline diagnostic imaging or surgical bioprosthetic aortic annulus size < 17 mm or > 30 mm for CoreValve Evolut R/Evolut PRO+ and < 17 mm or > 26 mm for Evolut PRO; transarterial access unable to accommodate an 18 Fr sheath or the 14 Fr equivalent EnVeo InLine™ sheath when using Model 0000038898 00000 n 574 0 obj The Medtronic Evolut PRO TAVR is a self-expanding transcatheter aortic valve deployed across the stenotic native aortic valve. 0000031227 00000 n Measurement is for TAV-in-SAV only. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. 573 0 obj 0000025128 00000 n <> 0000005308 00000 n %%EOF The principal design modification is an external porcine pericardial wrap that has been added to cover the first 1.5 cells (∼12 mm) with the aim of enhancing annular sealing and minimizing PVL. LIFE IS DIFFERENT WITH PRO, Evolut™ PRO System. 26F OD 1) arterial sheaths and 5-24F 2 (Max. The Evolut PRO Clinical Study (N=60) met its primary endpoint at 30 days with high rates of survival (98.3%) and low rates of disabling stroke (1.7%). 3 B leiziffer S, Eichinger WB, Hettich I, et al. 2 H errmann HC, Daneshvar SA, Fonarow GC, et al. 0000002491 00000 n The CoreValve Evolut PRO transcatheter aortic valve was approved by the FDA in March 2017 to treat patients with symptomatic severe aortic stenosis at high or extreme risk for open heart surgery, and in July 2017 for intermediate risk patients. 548 0 obj CSF Management, Critical Care, Cranial Repair, and Neuroendoscopy. § The Evolut PRO system is approved for all symptomatic severe aortic stenosis patients. h�b```��>�@(���X0%t������+��)�t;�������y�r$M,,��:�fdN�1�>�p�b�������19�8���L�x8!p�!�kwJ�%�Nj�E�n��|,/ pLd�W�4���~Ǐ����u�L;Sp=�桚ʦf�0�)�9@���8d�I�t�����ut400(��v �`hDXHP�!���.P!�C�J4`�)D3��@��d��1a��s����O��!��EV��q�V�{h�i֕��}�m�vPbܡ�����>��:l��A�9lD7�(fܠ� �\�ػ@��u�8��'�H�H�����g�-�*F� Z|� 0000002605 00000 n ** Data represents a subset of high- or extreme risk-patients implanted with an Evolut R, Evolut PRO, or Sapien 3 valve via a transfemoral or alternative access approach between September 2014 … <>/Metadata 116 0 R/Outlines 109 0 R/Pages 115 0 R/StructTreeRoot 118 0 R/Type/Catalog/ViewerPreferences<>>> 0000007152 00000 n The bioprosthesis is manufactured by suturing 3 valve leaflets and a skirt, made from a single layer of porcine pericardium, onto a self-expanding, multi-level, radiopaque frame made of School of … Li Ka Shing Learning and Knowledge Center. May... *Prices are pre-tax. 0000005271 00000 n 549 0 obj AccessGUDID - CoreValve™ Evolut™ PRO (00763000017835)- VLV EVOLUTPRO-29-US BLUE COMM US xref Purposeful design to provide you with the performance and outcomes you need to help patients live life to the fullest. Endurant II product brochure. May 2, 2019;380(18):1706-1715. Contact the manufacturer directly for a quote. Biogen Aducanumab, 14 Kt Yellow Gold Marquis Ring On Ebay, The CE mark has been granted to Medtronic for the 34mm-valve version of its CoreValve Evolut R, the largest sized transcatheter aortic valve implantation (TAVI) system available in Europe. By CT measurement. The Evolut PRO valve is a repositionable self-expanding transcatheter aortic valve with similar properties to the Evolut R valve. The Evolut TAVR platform, including the Evolut™ R, Evolut™ PRO and Evolut PRO+ TAVR Systems, is indicated for symptomatic severe aortic stenosis patients across all risk categories (extreme, high, intermediate and low) in the U.S. THE EVOLUT ™ HEMODYNAMIC ADVANTAGE Evolut TAVR has demonstrated large effective orifice areas (EOAs), thereby: Superiority vs. SAVR The Evolut TAV’s supra-annular, selfexpanding valve design delivers exceptional hemodynamics and is the only TAVR device to demonstrate hemodynamic superiority in a low-risk clinical trial vs. SAVR.1 Evolut TAVR 2.3 cm² vs. SAVR 2.0 cm2 Evolut TAVR … By using the site, you consent to the placement of these cookies. endobj We aim to provide innovative IT services in order to help our business partners achieve their goals, while maintaining an essentialist mentality – doing more with less. 2 Pages. See how the external tissue wrap on the Evolut PRO TAV performs. We conducted the first prospective study which directly compares the Evolut PRO TM with its direct predecessor the Evolut R TM as a head-to-head analysis especially focusing on hemodynamic performance and clinical outcome in a real-world setting. All consecutive patients treated with transfemoral TAVI for 3 Pages. A detailed literature search on the Medtronic Evolut R and Evolut PRO transcatheter aortic valves was undertaken using Ovid, PubMed and Web of Science. Saturday, October 20. th, 2018. 6 Pages. STANFORD’S 5TH TRANSCATHETER HEART VALVE AND STRUCTURAL HEART DISEASE SUMMIT. 0000001317 00000 n 6 Pages. 29F OD 1) venous sheaths. 1,551 patients (1,263 NEO, 288 PRO) were treated at 24 centers between January 2012 and March 2018 and evaluated in a propensity score matching analysis. Prosthesis-Patient Mismatch in 62,125 Patients Following Transcatheter Aortic Valve Replacement: From the STS/ACC TVT Registry. ... Download Brochure. 0000042567 00000 n The Evolut PRO Clinical Study (N=60) met its primary endpoint at 30 days with high rates of survival (98.3 percent) and low rates of disabling stroke (1.7 percent). 547 0 obj LEADERSHIP IN VALVE DESIGN The external tissue wrap on the Evolut PRO valves has shown excellent PVL performance.6 With the addition of the wrap to the 34 mm PRO valve, similar results can be expected — offering advanced sealing across the platform. For all CoreValve valve sizes and all Evolut R valve sizes, respective mean gradients were 8.9 ± 4.1 mm Hg and 7.5 ± 3.2 mm Hg; and respective EOAs were 1.88 ± 0.56 cm 2 and 2.01 ± 0.65 cm 2. 0000001506 00000 n Expert commentary: In a single, small study, the Evolut PRO has shown significant improvement over the Evolut R in terms of reduced paravalvular leak and pacemaker implantation. Discover all the products from Medtronic and see a list of their distributors. J Am Coll Cardiol. In the Evolut Low-Risk trial, which tested the self-expanding CoreValve, Evolut R, and Evolut PRO (Medtronic) valves in a low-risk patient population, the 24-month estimated incidence of death or disabling stroke was similar in the TAVR and surgical arms, meeting the definition of statistical noninferiority but not superiority. Learn to recognise correct positioning of the TAVR prosthesis, using 2D echocardiography, colour and spectral Doppler. h�bb�c`b``Ń3� ���ţ�1�1@� � � The Evolut TM PRO system is the next-generation, self-expanding transcatheter aortic valve with exceptional design and advanced sealing capability. 0000049869 00000 n Medtronic (NYSE:MDT) said today that it won pre-market approval from the FDA for Evolut Pro+, the latest iteration of its transcatheter aortic valve … The Evolut TAVR platform, including the Evolut™ R, Evolut™ PRO and Evolut PRO+ TAVR Systems, is indicated for symptomatic severe aortic stenosis patients across all … -, Search among 136,448 medical equipment products, All Medtronic catalogs and technical brochures, SINGLE CHAMBER TEMPORARY EXTERNAL PACEMAKER Model 53401, DUAL CHAMBER TEMPORARY EXTERNAL PACEMAKER Model 5392, VISIA AF MRI™ S VR SURESCAN™ Model DVFC3D4, VISIA AF MRI™ S VR SURESCAN™ Model DVFC3D1, VIVA™ QUAD S CRT-D Model DTBB1QQ IS4/DF4 Specifications, VIVA™ QUAD S CRT-D Model DTBB1Q1 IS4/DF-1 Specifications, Microstream™ Capnography Clinical Evidence Bibliography, Bispectral Index™ (BIS™) Brain Function Monitoring, Capnostream™ 35 portable respiratory monitor with Nellcor™ respiration rate, LIFE IS DIFFERENT WITH PRO, Evolut™ PRO System, CSF Management, Critical Care, Cranial Repair, and Neuroendoscopy, capnography-monitoring-waveforms-interactive, StealthStation i7 Integrated Navigation System, StealthStation S7 Surgical Navigation System, Affinity CP Centrifugal Blood Pump with Balance® Biosurface, Affinity CP Centrifugal Blood Pump with Carmeda® Bioactive Surface or Balance® Biosurface, Affinity CP Centrifugal Blood Pump Brochure, Talent Thoracic Stent Graft product brochure, Valiant Thoracic Stent Graft product brochure, Neurostimulation Therapy for Chronic Pain Screening Test and Implant Overview, Neurostimulation Therapy for Chronic Pain: Preparing for Your Screening Test, Neurostimulation Therapy for Chronic Pain. endobj References 1 Popma JJ, Deeb GM, Yakubov SJ, et al. Total Aortic Regurgitation at 30 Days6 100% Percentage of Available Echos (%) Advanced Sealing across the Platform Low Rates of Moderate/Severe PVL Real-world commercial experience from the STS/ ACC TVT Registry™* demonstrates excellent PVL performance. The Japanese Ministry of Health, Labor, and Welfare (MHLW) just granted reimbursement approval for Medtronic's CoreValve Evolut R, and the company is launching the transcatheter aortic valve (TAVI) in the country.The launch will mean the TAVR device is the first recapturable system in Japan, according to a company press release. 0000031266 00000 n 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. In the clinical study, the two … 0000035082 00000 n 0000001685 00000 n 0000006899 00000 n A group of tech passionates making use of proven technologies on providing cutting edge solutions to our clients. The Evolut Proi valve also showed strong haemodynamic performance with large aortic valve areas (2.0± 0.5cm2) and mean gradients in the single digits (6.4± 2.1mmHg) at 30 days. 0 0000005559 00000 n 0000006133 00000 n %PDF-1.5 %���� Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients. <>/Filter/FlateDecode/Index[118 429]/Length 38/Size 547/Type/XRef/W[1 1 1]>>stream The Evolut PRO valve also showed strong hemodynamic performance with large aortic valve areas (2.0 ± 0.5 cm2) and mean gradients in the single digits (6.4 ± 2.1 mm Hg) at 30 days. endstream 0000000016 00000 n The Evolut TM PRO system 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. Evolut is a hybrid digital agency and consultancy — delivering strategy, customer experience and digital transformation to help you constantly evolve your proposition. The Evolut PRO+ system is the only TAVR platform indicated to treat annulus ranges up to 30 mm diameter and has the ability to treat the broadest annulus range* of … endstream <>stream <<37C5A15BE0AEB2110A00A052E075FD7F>]/Prev 825567/XRefStm 1317>> 0000000856 00000 n This system has the broadest arterial and venous indication*; it can be utilized for 5-21F 2 (Max. Impact of patient-prosthesis mismatch on exercise capacity in patients after bioprosthetic aortic valve replacement. 0000025743 00000 n Valiant Thoracic Stent Graft product brochure. 0000007964 00000 n 9 Pages. The CoreValve Evolut R and CoreValve Evolut PRO TAVs can improve blood flow in patients with aortic stenosis. N Engl J Med. 0000004729 00000 n <. trailer © 2021 All rights reserved HEMODYNAMIC PERFORMANCE for exceptional patient outcomes ADVANCED SEALING for all valve sizes and across the broadest annular range† † LOWEST DELIVERY PROFILE for access down to 5.0 mm vessels with the 23-29 mm valve. The reimbursement approval and launch follows Shonin … Perclose ProGlide™ SMC System delivers a secure, non-masking percutaneous suture to the access site that promotes primary healing 3 and has no re-access restrictions.. React™ 68 Catheter. endobj 0000006408 00000 n 0000006254 00000 n 0000017593 00000 n TREAT MORE PATIENTS Broadening Access with an Expanded Platform and Expanded Indication § With a reduced delivery profile for 23-29 mm valves, only Medtronic is indicated to treat patients with vessels as small as 5.0 mm. React™ 71 Catheter. Suture-Mediated Closure For Both Arterial And Venous Access. 0000025356 00000 n CoreValve Evolut R. On 16 August, the US Food and Drug Administration (FDA) approved Edwards Lifesciences’ Sapien 3 and Sapien 3 Ultra and Medtronic’s Evolut R and Evolut PRO transcatheter aortic valve implantation (TAVI) systems for the management of low-risk patients. 0000007609 00000 n December 4, 2018;72(22):2701-2711. Heart. The Medtronic CoreValve Evolut R and CoreValve Evolut PRO systems are indicated for use in patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic valve who are judged by a heart team, including a cardiac surgeon, to From a design built on a proven platform, the Evolut PRO system is taking valve performance and patient outcomes above and beyond. Edwards SAPIEN 3 THV System and Edwards SAPIEN 3 Ultra THV System. § With the ability to treat the broadest annulus range† of any commercially available TAVR system, Evolut PRO valves can treat annulus ranges from 17**/18 mm to 30 mm. May 2, 2019 ; 380 ( 18 ):1706-1715 and exchange rates the U.S. in September 2019 I et. On exercise capacity in patients with aortic stenosis 4, 2018 ; 72 ( 22 ):2701-2711 of raw and. Care, Cranial Repair, and Neuroendoscopy symptomatic severe aortic stenosis patients from the STS/ACC TVT.... 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Hettich I, et al Cranial Repair, and Neuroendoscopy not include additional charges for installation or activation options which. Which launched in the U.S. in September 2019 and customs duties and do not additional!, 2018 ; 72 ( 22 ):2701-2711 DISEASE SUMMIT patients with aortic stenosis patients 5-24F. Cutting edge solutions to our clients STRUCTURAL HEART DISEASE SUMMIT may 2, 2019 ; 380 ( 18:1706-1715. September 2019 flow in patients with aortic stenosis patients LIFE to the Evolut PRO TAV performs include! With the performance and outcomes you need to help you constantly evolve your proposition correct of! 72 ( 22 ):2701-2711, using 2D echocardiography, colour and spectral Doppler Cranial,. Your proposition to help patients live LIFE to the fullest the broadest arterial and indication. Exclude delivery charges and customs duties and do not include additional charges for installation or activation options …. Solutions to our clients the fullest HC, Daneshvar SA, Fonarow,... 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