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Vascular complications after transcatheter aortic valve replacement: insights from the PARTNER (Placement of Aortic Transcatheter Valve) trial. Response: Larger multicenter trials are needed to confirm our findings. Genereux P, et al. The low profile of the CoreValve and Evolut R systems helps minimize trauma during delivery, allowing physicians to treat patients with small or calcified vasculature. Methods The Medtronic Evolut PRO Clinical Study included 60 patients undergoing transcatheter aortic valve replacement with the Evolut PRO valve at 8 investigational sites in the United States. 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) platform.Six-month data from the newest-generation Evolut PRO System demonstrated continued benefits of its unique valve … The Evolut PRO Clinical Study (N=60) met its primary endpoint at 30 days with high rates of survival (98.3 percent) and low rates of disabling stroke (1.7 percent). Clinical outcomes at 30 days were evaluated using Valve Academic Research Consortium-2 criteria. 1. Finally, our reported permanent pacemaker implantation rate of 28% with the Evolut 34 mm seems higher than the rates presented in the Evolut R CE Mark Clinical Study (11.7%) and in the Evolut R U.S. Study (16.4%) , and higher than the rate recently proposed in a more contemporary cohort of patients treated with the Medtronic Core valve (18.2%) . MedicalResearch.com: What recommendations do you have for future research as a result of this work? The Evolut PRO valve also showed strong hemodynamic performance with large aortic valve areas (2.0 ± 0.5 cm2) and mean gradients in the single digits (6.4 ± 2.1 mm Hg) at 30 days. The Evolut PRO valve also showed strong hemodynamic performance with large aortic valve areas (2.0 ± 0.5 cm 2) and mean gradients in the single digits (6.4 ± 2.1 mm Hg) at 30 days. Response: The Evolut R TM TAVR valve is as effective as the Evolut PRO TM in treating significant aortic valve stenosis.

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