Medtronic plc has kicked off two clinical trials of its Evolut transcatheter aortic valve replacement (TAVR) system. Patients assigned to TAVR were treated with one of three self-expanding, supraannular bioprostheses (CoreValve, Evolut R, or Evolut PRO; Medtronic) (Fig.
S1 … ADVANTAGE . Patients were randomly assigned in a 1:1 ratio to undergo either TAVR (n = 725) or SAVR (n = 678). Medtronic Transcatheter Aortic Valve Replacement (TAVR) Low Risk Bicuspid Study The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Medtronic Evolut PRO TAVR November 2, 2017 -- Dublin and Denver -- Medtronic plc (NYSE:MDT) today presented new data at the Transcatheter Cardiovascular Therapeutics (TCT) Annual Meeting showcasing the excellent clinical performance of the Evolut™ Transcatheter Aortic Valve Replacement (TAVR…
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. Broadest annulus range based on CT derived diameters.
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. Some are essential to make our site work; others help us improve the user experience. The Medtronic CoreValve Evolut R, CoreValve Evolut PRO, and Evolut PRO+ systems are indicated for use in patients with symptomatic heart disease due . 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 any commercially available TAVR system. If a course you have taken is still not showing as complete, please send us an e-mail with the name of the course and date you completed it. Built upon the proven Evolut platform, the Evolut PRO+ system offers the lowest delivery profile for 23-29 mm valves, excellent hemodynamics, the broadest annulus range,* and advanced sealing with an external tissue wrap. 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. 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 Medtronic TAVR Heart Valve The Medtronic TAVR heart valve includes three different valves, the CoreValve, the Evolut R, and the Evolut PRO 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。 In 2016, Medtronic launched its third-generation (Evolut PRO) TAVR system with recapturable and repositionable capabilities and advanced sealing. 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. May 2, 2019;380(18):1706-1715. 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). The Medtronic CoreValve Evolut R, CoreValve Evolut PRO, and Evolut PRO+ systems are indicated for use in patients with symptomatic heart disease due . Medtronic has secured approval from the US Food and Drug Administration (FDA) for its next-generation Evolut PRO+ TAVR system to treat symptomatic severe aortic stenosis patients. HEMODYNAMIC PERFORMANCE . "The outcome of this important head-to-head study will allow heart teams to more selectively tailor clinical decision making to ensure the right valve is selected for the right patient."
The Evolut PRO valve features an outer tissue wrap that adds surface area contact between the valve and the native aortic annulus to further advance valve sealing.
In 2016, Medtronic launched its third-generation (Evolut PRO) TAVR system with recapturable and repositionable capabilities and advanced sealing. In Medtronic's announcement, Nicolas M. Van Mieghem, MD, commented, "The Evolut Pro valve has shown impressive clinical outcomes, with low paravalvular leak and pacemaker rates. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together. More than 2 million patients live with symptomatic moderate and asymptomatic aortic stenosis in the U.S., which represents more than 40% of the total AS population in the U.S. In addition, bicuspid aortic valve patients across all risk categories may be candidates for TAVR in the U.S. The Evolut PRO Study is a prospective, multicenter, controlled, non-randomized single-arm study. Cardiovascular In addition, bicuspid aortic valve patients across all risk categories may be candidates for TAVR in the U.S. 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. Actual results may differ materially from anticipated results. Update my browser now.
Medtronic to conduct feasibility study of Evolut TAVR platform. For some patients, the risk of the Medtronic TAVR procedure may outweigh the benefits.
The company has also commercially launched the new-generation TAVR system, which is developed based on the self-expanding and supra-annular Evolut TAVR platform.
Enrolling approximately 700 patients globally, the study will evaluate valve performance in patients with small annuli and those who are candidates for TAV-in-SAV procedures (transcatheter valve implanted inside of a failed surgical valve), which combined, represent more than 40% of the global TAVR market. Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Evolut is now indicated in Canada for severe aortic stenosis patients across all risk categories (extreme, high, intermediate and low). Medtronic estimates those two groups account for more than 40% of the global TAVR market, suggesting a clear win for the Evolut system could strengthen the company’s pitch for a significant slice of the fast-growing sector. In addition, bicuspid aortic valve patients across all risk categories may be candidates for TAVR in the U.S.. The expanded use addendum is a multi-center, prospective, non-randomized continued access trial. MedicalResearch.com: What recommendations do you have for future research as a result of this work? Home S1 in the Supplementary Appendix). The outcomes observed from in this study will help shape our clinical strategy to pursue expansion of the therapy to new populations who may benefit.". Valve Sizing Built upon the proven Evolut platform, the Evolut PRO+ system offers the lowest delivery profile for 23-29 mm valves, excellent hemodynamics, the broadest annulus range,* and advanced sealing with an external tissue wrap. Exclusion Criteria: Contraindicated for treatment with the Evolut™ PRO or Evolut™ PRO+ system in accordance with the Instructions for Use ADVANTAGE . Medtronic Hancock™ Modified Orifice (M.O.) You may at any time change the settings regarding cookies. 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. Moderate AS remains undertreated due to a lack of clinical evidence informing treatment guidelines, while asymptomatic AS is undertreated due to the absence of common symptoms that would indicate a heart valve problem, such as shortness of breath, fatigue, dizziness, chest pains or palpitations. 2. 1. See how the external tissue wrap on the Evolut PRO TAV … By using the site, you consent to the placement of these cookies. "Hemodynamic performance is particularly important in many patients with aortic stenosis, including those with small annuli, surgical aortic valves needing a TAV-in-SAV procedure, patients with left ventricular dysfunction, and those who are young and most active. LONDON, England—Treatment with the self-expanding Evolut PRO/R transcatheter heart valve (Medtronic) for severe symptomatic aortic stenosis significantly improves hemodynamics and effectively enlarges the valve area in patients with bicuspid aortic valves (BAV), according to preliminary data from the BIVOLUT-X registry. 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. Medtronic to conduct feasibility study of Evolut TAVR platform. Study Design. The Evolut R transcatheter aortic heart valve can be recaptured and repositioned. Due to its focus on small annulus patients, the SMART Trial will enroll predominantly women, which will provide important clinical insight into a currently underrepresented patient population in TAVR literature. 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. In 2017, the third-generation Evolut PRO TAVR system was approved in the U.S. and Europe for extreme-, high- and intermediate-risk patients. In addition, bicuspid aortic valve patients across all risk categories may be candidates for TAVR in the U.S. 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. 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. Keywords: Medtronic Controlled Created Date 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 2017, the third-generation Evolut PRO TAVR system was approved in the U.S. and Europe for extreme-, high- and intermediate-risk patients. Read our privacy statement to learn more.
The Medtronic CoreValve™ Evolut™ R system is 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 be Popma JJ, Deeb GM, Yakubov SJ, et al. The Evolut™ EXPAND TAVR I Feasibility Study, which has been submitted to the FDA for Investigational Device Exemption (IDE) approval, would enroll up to 150 patients across both subgroups and evaluate the use of TAVR in patients before signs of left ventricular dysfunction are observed, and will assess the clinical and hemodynamic performance of the Evolut TAVR system to inform future clinical work. Primary safety endpoints were all-cause mortality and disabling stroke at 30 days, and the primary efficacy endpoint was percentage of patients with no or tra\ ce aortic regurgitation at 30 days. Thanks for your interest in the Sales Training & Education Strategist - US, TAVR … This site uses cookies to store information on your computer. It is designed to work like your own heart valve. superior outcomes for TAVR with the self-expanding CoreValve versus surgery. The studies provide consistent data establishing the safety and efficacy of the CoreValve system, and confirm its durability out to five years. Be part of one of the world’s leading medical technologies and solutions companies. SURTAVI: Two Year Complete Results from a Randomized Trial of a Self-expanding Transcatheter Heart Valve vs. Surgical Aortic Valve Replacement in Patients with Severe Aortic Stenosis at Intermediate Surgical Risk. The Evolut PRO+ TAVR System includes four valve sizes with an external […] Herein we report the … Healthcare Professionals Fridley, Minn.-based Medtronic won CE Mark approval in the European Union for predecessor valve Evolut Pro in July 2017. "Limited clinical research has shown that early intervention may reduce the high rates of mortality often seen in these patients as the disease progresses further down the road. The Medtronic CoreValve Evolut R System and Medtronic CoreValve Evolut PRO System each consists of a transcatheter aortic valve (TAV), a delivery catheter, and a loading system. N Engl J Med.
Dr. Herrmann has received institutional research funding and financial compensation from Edwards Lifesciences and Medtronic. 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.