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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...
We demonstrate the technical aspects of a novel adjustable mitral ring. This new ring was implanted in a female landrace pig, for training and educational purposes. It can be adjusted independently in...
An aortic annuloplasty ring could be useful for aortic valve repair. This trial evaluated intermediate-term outcomes of internal geometric ring annuloplasty for repair of trileaflet and bicuspid aorti...
Approximately one-third of patients suffering from aortic insufficiency (AI) present also with an ascending aortic aneurysm. AI is most commonly due to a combination of sinotubular junction and annu...
Functional mitral regurgitation (FMR) is a significant complication of left ventricle (LV) dysfunction associated with poor prognosis and commonly treated by undersized ring annuloplasty. This study a...
Percutaneous edge-to-edge repair of severe mitral regurgitation has been established as an alternative treatment option for patients at high risk for cardiac surgery. More recently, the introduction o...
A soft, loose-fitting polyurethane sheath, closed at one end, with flexible rings at both ends. The device is inserted into the vagina by compressing the inner ring and pushing it in. Properly positioned, the ring at the closed end covers the cervix, and the sheath lines the walls of the vagina. The outer ring remains outside the vagina, covering the labia. (Med Lett Drugs Ther 1993 Dec 24;35(12):123)
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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Device designed to wear externally to support muscular skeletal system in various movements such as RANGE OF MOTIONS; WEIGHT-BEARING; GAIT; and LOCOMOTION.
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Cardiology is a specialty of internal medicine. Cardiac electrophysiology : Study of the electrical properties and conduction diseases of the heart. Echocardiography : The use of ultrasound to study the mechanical function/physics of the h...