The CoreValve and Evolut transcatheter aortic valve replacement (TAVR) devices have been evaluated in more than a dozen clinical trials. Elective surgeries seen driving Q3 medtech comeback, but can it last? The studies provide consistent data establishing the safety and efficacy of the CoreValve system, and confirm its durability out to five years. Your email address will not be published. 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. Evolut is not yet approved for low-risk patients in Japan but is "actively under review" by regulators, the spokesperson said. Want to share a company announcement with your peers? Dive Brief: Medtronic's Evolut transcatheter aortic valve implantation system now has an expanded CE mark to treat patients with severe aortic stenosis who are at low risk for mortality in traditional open heart surgery, the medtech giant said Monday. dropiewski@mbexec.com, Your email address will not be published. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Medtronic's European launch for low-risk patients follows rival Edwards Lifesciences' receipt in November of the CE mark to expand the use of its Sapien 3 transcatheter valve in the low-risk population and comes just as surgeons and device makers are gaining confidence in a rebound of elective procedures after a steep dropoff in April tied to the onset of the COVID-19 pandemic. This field is for validation purposes and should be left unchanged. 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. Edwards' Partner 3 study showed Sapien 3 was superior to conventional surgery, while Medtronic's Evolut Low Risk Trial found TAVR was as good as open surgery. Medtronic has now added to the evidence by releasing results from a clinical trial of its Evolut TAVR devices in bicuspid patients. Actual results may differ materially from anticipated results. “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. There are several types of Medtronic heart valves, including CoreValve™, Evolut™ R, and Evolut™ PRO valves that come in different sizes. Medtronic also announced plans to begin a feasibility study of the Evolut TAVR platform to evaluate the self-expanding, supra-annular valve in … 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.”. Medtronic's European launch for low-risk patients follows rival Edwards Lifesciences'. CardiacVascularNews is not affiliated with any source of content and only wishes to share the most relevant news in the industry. 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.
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