The purpose of the Medtronic Evolut PRO US Clinical Study was to evaluate long-term outcomes following TAVR with the Evolut PRO System in patients with severe, symptomatic aortic stenosis at increased risk for SAVR [6]. Patients assigned to TAVR were treated with one of three self-expanding, supraannular bioprostheses (CoreValve, Evolut R, or Evolut PRO; Medtronic) (Fig. The Dublin-based med-tech giant also has … The … The Evolut PRO valve is a repositionable self-expanding transcatheter aortic valve with similar properties to the Evolut R valve. Medtronicの経カテーテル大動脈弁置換術用デバイスは、初期の CoreValve™ のプラットフォームをベースに自己拡張型 Evolut™ Rへ、そして更なるシーリング性能を備えた Evolut™ PRO へと展開を続けています。 You may at any time change the settings regarding cookies. Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Medtronic Also Begins Feasibility Study of Evolut TAVR System in Moderate and Asymptomatic Aortic Stenosis Patients DUBLIN, Oct. 14, 2020 /PRNewswire/ -- Medtronic plc (NYSE:MDT), a global leader... Medtronic Also Begins Feasibility Study of Evolut TAVR System in Moderate and Asymptomatic Aortic Stenosis Patients. 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. Outcomes in Transcatheter Aortic Valve Replacement for Bicuspid versus Tricuspid Aortic Valve Stenosis, De Biase Chiara BivolutX presented at PCR LV 2019. Reardon MJ. Be part of one of the world’s leading medical technologies and solutions companies. Medtronic Also Begins Feasibility Study of Evolut TAVR System in Moderate and Asymptomatic Aortic Stenosis Patients DUBLIN, Oct. 14, 2020 /PRNewswire/ — Medtronic plc (NYSE:MDT), a global leader in structural heart therapies, today announced it will begin a randomized, head-to-head study comparing two transcatheter aortic valve replacement (TAVR) systems in patients … 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. The Evolut R and Evolut PRO valves have the added feature of being recapturable to assist your doctor with placing your new heart valve. September 23, 2019—Medtronic announced FDA approval and the United States launch of the company's Evolut Pro+ transcatheter aortic valve replacement (TAVR) system, which builds off the company's self-expanding, supra-annular Evolut TAVR platform. The expanded use addendum is a multi-center, prospective, non-randomized continued access trial. The Evolut TAVR platform – including the Evolut™ R, Evolut™ PRO and Evolut™ PRO+ TAVR Systems – is indicated for symptomatic severe AS patients across all risk categories (extreme, high, intermediate and low) in the U.S. DUBLIN, Oct. 14, 2020 /PRNewswire/ -- Medtronic plc (NYSE:MDT), a global leader in structural heart therapies, today announced it will begin a randomized, head-to-head study comparing two transcatheter aortic valve replacement (TAVR) systems in patients with severe symptomatic aortic stenosis (ssAS). Medtronic plc has kicked off two clinical trials of its Evolut transcatheter aortic valve replacement (TAVR) system. 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 … The Medtronic CoreValve Evolut R, CoreValve Evolut PRO, and Evolut PRO+ systems are indicated for use in patients with symptomatic heart disease due . 10 Medtronic Evolut PRO Overview | Medtronic - Confidential *Bench top evaluation of the frame contacting the annulus based on a CT analysis of 1 patient; Image Courtesy of Dr. Piazza and Prof. Lange, German Heart Center, Munich Germany NOTE: Images are for illustrative purposes only and may not be indicative of clinical performance. Evolut is now indicated in Canada for severe aortic stenosis patients across all risk categories (extreme, high, intermediate and low). "Moderate aortic stenosis, if left untreated, can be just as deadly for patients as the more severe forms of the disease," said Jeffrey Popma, M.D., chief medical officer and vice president, medical affairs for the Structural Heart business, which is part of the Cardiac and Vascular Group at Medtronic. DUBLIN, Sept. 23, 2019 (GLOBE NEWSWIRE) -- Medtronic plc (NYSE:MDT), a global leader in heart valve therapies, today announced U.S. Food and Drug Administration (FDA) approval and U.S. launch of the Evolut™ PRO+ TAVR System – a new-generation Medtronic TAVR system that builds off the proven self-expanding, supra-annular Evolut TAVR platform. In addition, bicuspid aortic valve patients across all risk categories may be candidates for TAVR in the U.S. The CoreValve Evolut TAVR platform consists of the CoreValve, CoreValve Evolut R and the CoreValve Evolut PRO systems, all of which have received … Transcatheter Aortic Valve Replacement. The Medtronic CoreValve ™ Evolut ™ R, CoreValve ™ Evolut ™ PRO, and Evolut ™ PRO+ systems are indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy. https://www.medtronic.com/us-en/index.html?intcmp=mdt_com_country_selector_dropdown_atlasr22016, Electromagnetic Compatibility Guide for Cardiac Devices, Minimally Invasive Therapies (formerly Covidien), Information About Proposition 65 for California Customers, California Transparency in Supply Chains Act. By using the site, you consent to the placement of these cookies.