CoreValve Evolut Pro. Based on excellent data from the STS/ACC TVT Registry, bicuspid patients (excluding low risk), will for the first time, be indicated for TAVR, which is another big win for patients and the future of the therapy.” Dr. Tchétché is an interventional cardiologist and Director of the Structural Heart Disease Department at Clinique Pasteur in Toulouse, France.
right-arrow In the United States, the Evolut TAVR platform is indicated for symptomatic severe aortic stenosis patients across all risk categories (extreme, high, intermediate, and low). © 2020 Bryn Mawr Communications II, LLC.
The Medtronic CoreValve Evolut R System and Medtronic CoreValve Evolut PRO System were previously approved for the treatment of severe aortic … Heart teams will have more freedom to choose the best aortic valve replacement procedure based on each patient’s individual characteristics.” Dr. Modine is a cardiac surgeon at Hôpital Cardiologique Lille, in Lille, France.
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“The low-risk indication marks an important milestone for patients across Europe as TAVR expands into a potentially younger and more active patient population,” commented Evolut Low-Risk trial investigator Thomas Modine, MD, in Medtronic's press release. Medtronic has received the CE mark for its CoreValve Evolut Pro valve for the treatment of severe aortic stenosis for symptomatic patients who are at intermediate, high or extreme risk for open heart surgery. All Rights Reserved • Privacy Policy. Created with Sketch. Built on the proven self-expanding Evolut platform, PRO+ features four valve sizes and the smallest delivery profile currently on the market: Four valve sizes (23mm, 26mm, 29mm and 34mm) with an external tissue wrap that increases surface contact area with the... A lower delivery profile … 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. However, the results obtained on the CoreValve System and CoreValve Evolut R System are considered applicable to the CoreValve Evolut PRO System based on prior demonstration of device … Created with Sketch. According to Medtronic, the low-risk patient population is the final surgical risk category to be approved for this alternative to surgical aortic valve replacement (SAVR) and includes patients who may be younger and more active than higher-risk patients, noted the company. The Medtronic CoreValve Evolut PRO System was not used in the trial. The self-expanding, repositionable, supra-annular valve has been designed with an outer porcine pericardial tissue wrap intended to improve … The data were concurrently published by Jeffrey J. Popma, MD, et al in The New England Journal of Medicine (2019; 380:1706-1715). The US Food and Drug Administration (FDA) has cleared Medtronic’s next-generation TAVR valve, the CoreValve Evolut PRO, for patients with symptomatic severe aortic stenosis and a high or extreme surgical risk, the company announced Wednesday.. Results. 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. Cardiac Interventions Today (ISSN 2572-5955 print and ISSN 2572-5963 online) is a publication dedicated to providing coverage of the latest developments in technology, techniques, clinical studies, and regulatory and reimbursement issues in the field of coronary and cardiac interventions.
The expanded low-risk indication approval is based on clinical data from the global, prospective, randomized, multicenter Evolut Low-Risk trial, which evaluated three generations of Medtronic valves (CoreValve, Evolut R, and Evolut Pro) against SAVR in more than 1,400 patients. It’s also encouraging that we now have new labeling to address a large portion of bicuspid valve patients, too.
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