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Georg Nickenig, Christoph Hammerstingl, Robert Schueler, Yan Topilsky, Paul A Grayburn, Alec Vahanian, David Messika-Zeitoun, Marina Urena Alcazar, Stephan Baldus, Rudolph Volker, Michael Huntgeburth, Ottavio Alfieri, Azeem Latib, Giovanni La Canna, Eustachio Agricola, Antonio Colombo, Karl-Heinz Kuck, Felix Kreidel, Christian Frerker, Felix C Tanner, Ori Ben-Yehuda, Francesco Maisano
OBJECTIVES: This study sought to show safety and efficacy of the Cardioband system during 6 months after treatment. BACKGROUND: Current surgical and medical treatment options for functional mitral regurgitation (FMR) are limited. The Cardioband system (Valtech Cardio, OrYehuda, Israel) is a novel transvenous, transseptal direct annuloplasty device. METHODS: Thirty-one patients (71.8 ± 6.9 years of age; 83.9% male; EuroSCORE II: 8.6 ± 5.9) with moderate to severe FMR, symptomatic heart failure, and depressed left ventricular function (left ventricular ejection fraction 34 ± 11%) were prospectively enrolled...
October 10, 2016: JACC. Cardiovascular Interventions
Maurizio Taramasso, Devdas T Inderbitzin, Andrea Guidotti, Fabian Nietlispach, Oliver Gaemperli, Michel Zuber, Francesco Maisano
Direct mitral valve annuloplasty is a transcatheter mitral valve repair approach that mimics the conventional surgical approach to treat functional mitral regurgitation. The Cardioband system (Valtech Cardio, Inc., Or-Yehuda, Israel) is delivered by a trans-septal approach and the implant is performed on the atrial side of the mitral annulus, under live echo and fluoroscopic guidance using multiple anchor elements. The Cardioband system obtained CE mark approval in October 2015, and initial clinical experiences are promising with regard to feasibility, safety and efficacy...
2016: Multimedia Manual of Cardiothoracic Surgery: MMCTS
Francesco Maisano, Hugo Vanermen, Joerg Seeburger, Michael Mack, Volkmar Falk, Paolo Denti, Maurizio Taramasso, Ottavio Alfieri
OBJECTIVES: The aim of the study was to evaluate the technical feasibility and performance of a transcatheter mitral annuloplasty system. METHODS: Adult swines (n = 15) underwent left thoracotomy through the 4th-5th intercostal space. A transcatheter device (CardioBand, Valtech-Cardio Ltd) was introduced through an 18F sheath through the left atrium and attached to the annulus between the posterior and anterior commissures using echocardiographic and fluoroscopic guidance, on the beating heart...
September 2012: European Journal of Cardio-thoracic Surgery
Francesco Maisano, Paolo Denti, Hugo K Vanermen, Joerg Seeburger, Volkmar Falk, Friedrich Wilhelm Mohr, Michael J Mack, Ottavio R Alfieri
OBJECTIVE: Neochordae implantation is a well-established surgical solution for the treatment of mitral valve prolapse. The main limitation to wide usage of the technique has been the difficulty associated with accurate determination of neochordal length. We describe a system specifically designed to facilitate rapid, uncomplicated implantation and off-pump, beating heart adjustment of neochordae. METHODS: Five swine underwent implantation of the adjustable neochordal system (V-Chordal; Valtech Cardio LTD, Israel) while on cardiopulmonary bypass after cutting native chordae to create a significant lesion...
July 2010: Innovations: Technology and Techniques in Cardiothoracic and Vascular Surgery
Francesco Maisano, Micaela Cioni, Joerg Seeburger, Volkmar Falk, Friedrich Wilhelm Mohr, Michael J Mack, Ottavio Alfieri, Hugo Vanermen
OBJECTIVE: This study aimed to determine the acute and chronic performance of a new system designed to conduct beating-heart implantation and off-pump adjustment of neochordal length. METHODS: In 14 adult sheep (group A) selected to undergo beating-heart cardiopulmonary bypass, the left atrium was opened through a left thoracotomy. Two or more primary chordae in the A2 region were severed to produce a model of a flail leaflet. A chordal adjustment mechanism (V-Chordal, Valtech Cardio Ltd...
October 2011: European Journal of Cardio-thoracic Surgery
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