The study includes pre-specified endpoints of hemodynamic (blood flow) superiority and clinical non-inferiority with the Evolut platform for mortality, stroke, or rehospitalization at 12 months. http://www.prnewswire.com/news-releases/medtronic-launches-head-to-head-tavr-study-comparing-the-evolut-tavr-platform-against-the-edwards-sapien-valve-in-small-annulus-patients-301152207.html, Start Here! This site uses cookies to store information on your computer. Medtronic Evaluates TAVR in New Patient Populations Medtronic also announced plans to begin a feasibility study of the Evolut™ TAVR platform to evaluate the self-expanding, supra-annular valve in patients with symptomatic moderate and asymptomatic severe aortic stenosis, new patient populations outside of current guidelines and indications for aortic valve replacement. Medtronic Also Begins Feasibility Study of Evolut TAVR System in Moderate and Asymptomatic Aortic Stenosis Patients. “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 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. The EvolutTM R valve design promotes single-digit gradients and large effective orifice areas (EOAs): The supra-annular valve optimizes coaptation in non-circular anatomy with supra-annular valve position and conforms to the native annulus. 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. 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. Its self-expanding nitinol frame enhances the ability to conform and seal to the native annulus. 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). In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. Some are essential to make our site work; others help us improve the user experience. Public Relations https://europe.medtronic.com/xd-en/index.html?intcmp=mdt_com_country_selector_dropdown_atlasr22017. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together. Medtronic Also Begins Feasibility Study of Evolut TAVR System in Moderate and Asymptomatic Aortic Stenosis Patients Medtronic plc a global leader in … The randomized trial, which met its primary non-inferiority endpoint of all-cause mortality or disabling stroke at two years compared to surgery (5.3 percent versus 6.7 percent; posterior probability of non-inferiority >0.999), was presented today at the American College of Cardiology 68th Annual Scientific Session (ACC.19) and published simultaneously in TheNew England Journal of Medicine (NEJM)[i]. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world. February 13, 2017;10(3):268-275. In addition, the EnVeoTM PRO delivery system provides you the option to recapture and reposition2 for more accurate placement. 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. The TAVR treatment arm also showed statistically lower rates of heart failure hospitalizations (3.2 percent versus 6.5 percent) and disabling stroke (0.8 percent versus 2.4 percent) compared to surgery at 12 months. See the Evolut TAVI manufacturing process and our commitment to quality in every step. +1-763-505-3780, Ryan Weispfenning The Evolut TAVR system is not approved in any geography for use in patients considered to be at a low risk of surgical mortality. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together. TAVR demonstrated excellent hemodynamic (blood flow) performance with significantly lower mean aortic valve gradients (8.6 mm Hg versus 11.2 mm Hg) and larger EOAs (effective orifice area) than surgery (2.3 vs. 2.0) at 12 months. JACC Cardiovasc Interv. Some are essential to make our site work; others help us improve the user experience. Medtronic also announced plans to begin a feasibility study of the Evolut™ TAVR platform to evaluate the self-expanding, supra-annular valve in patients with symptomatic moderate and asymptomatic severe aortic stenosis, new patient populations outside of current guidelines and indications for aortic valve replacement. The Evolut R system received CE (Conformité Européene) Mark for intermediate risk severe aortic stenosis patients in 2016. "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 majority of study subjects (72.4 percent) experienced no/trace PVL and no incidents of moderate or severe PVL were observed at 30 days. 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.". If you continue, you may go to a site run by someone else. Less information (see less), The supra-annular valve design and oversizing feature of the nitinol frame maximize the valve orifice and leaflet coaptation.1.
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