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Annuloplasty device for repair of mitral valve regurgitation with option to adjust device post implant off pump, to optimize correction of mitral regurgitation. Unlike conventional annuloplasty ring, the Cardinal system offers the clinician the opportunity to make adjustments after weaning from cardiopulmonary bypass. Adjustability is expected to reduce the number of patients leaving the operating room with residual regurgitation after mitral valve repair.
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Mitral Valve Insufficiency
Adjustable Annuloplasty Ring with option to adjust off pump., Device: Adjustable Annuloplasty Ring (with option to adjust off-pump)
Hospital San Raffaele
Valtech Cardio Ltd
Published on BioPortfolio: 2014-07-23T21:08:52-0400
The device is a dynamic annuloplasty ring/band that is able to be adjusted in order to correct for mitral regurgitation intraoperatively or postoperatively, off-pump.
Evaluation of the technical feasibility and safety of the Mitral Adjustable Annuloplasty Ring.
The purpose of this study is to collect data on the effectiveness and clinical outcomes of the MEMO 3D Annuloplasty ring as used for mitral valve repair.
The goal of the study is to identify the patients who get successfully implanted with, and benefit from the implantation of a Profile 3D annuloplasty ring in terms of chronic relief of reg...
This study aims to compare whether De Vega's Suture annuloplasty is equally effective in reducing the progression of Functional Tricuspid regurgitation as that claimed for Ring annuloplast...
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The configuration of the native annulus changes from nearly flat in the diastolic phase to saddle-shaped in the systolic phase. The present study was conducted to test a novel remodeling annuloplasty ...
Ring annuloplasty is the gold standard of surgical repair in degenerative mitral valve disease. However, prosthetic annuloplasty has some drawbacks and potential hazards. Suture annuloplasty theoretic...
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Removal of a MEDICAL DEVICE from the market due to the identification of an intrinsic property of the device that results in a serious risk to public health.
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