Edwards Lifesciences wins CE Mark for Pascal mitral repair device

Edwards Lifesciences (NYSE:EW) said late yesterday that it won CE Mark approval in the European Union for its Pascal transcatheter valve repair system intended to treat mitral regurgitation. The Pascal system is designed to reduce mitral regurgitation while maintaining native anatomy and features contoured, broad paddles to maximize coaptation of the mitral leaflets and a central spacer to fill the regurgitant orifice area, the Irvine, Calif.-based company said. The newly launched system also includes a delivery system intended for independent leaflet capture to optimize leaflet position, Edwards said. “Mitral valve disease is complex, varied and prevalent, and patients are in significant need of multiple safe and effective therapies to treat debilitating symptoms that can lead to a high rate of mortality. The introduction of the Pascal system to clinicians and patients in Europe provides a differentiated, minimally-invasive therapy to address the needs of patients with mitral regurgitation,” transcatheter mitral and tricuspid therapies corp VP Bernard Zovighian said in a press release. Edwards said that is engaged in a U.S. pivotal trial of the device, the CLASP IID study, which it hopes will support eventual FDA clearance of the system. “The Pascal system is uniquely designed for optimized valve leaflet capture and coaptation, and to help operators achieve their ultimate goal of safe and effective mitral regurgitation reduction for their pat...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiovascular Featured Regulatory/Compliance Replacement Heart Valves Edwards Lifesciences Source Type: news

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Authors: Muntané-Carol G, Guimaraes L, Ferreira-Neto AN, Wintzer-Wehekind J, Junquera L, Del Val D, Faroux L, Philippon F, Rodés-Cabau J Abstract Introduction: Transcatheter aortic replacement (TAVR) has revolutionized the treatment of aortic stenosis during the last years. Despite improvements in transcatheter heart valve systems, the rate of conduction disturbances after TAVR, particularly new-onset left bundle branch block (new-onset LBBB), has not decreased over time. Areas covered: Overview of the current data regarding new-onset LBBB post-TAVR focusing on clinical outcomes. Expert opinion: New-o...
Source: Expert Review of Medical Devices - Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research
Conclusion In case of relevant heart valve disease after pneumonectomies, heart valve surgeries are feasible. [...] Georg Thieme Verlag KG Stuttgart · New YorkArticle in Thieme eJournals: Table of contents  |  Abstract  |  open access Full text
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Source: Medgadget - Category: Medical Devices Authors: Tags: Cardiac Surgery Cardiology Source Type: blogs
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Source: Harvard Health Blog - Category: Consumer Health News Authors: Tags: Health Heart Health Surgery Source Type: blogs
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