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MitraClip (mitral clip) is a medical device used to treat mitral valve regurgitation for individuals who should not have open-heart surgery. It is implanted via a tri-axial transcatheter technique and involves suturing together the anterior and posterior mitral valve leaflets.
An FDA advisory committee has voted that the benefits outweigh the risks for Abbott's MitraClip device in treating mitral regurgitation patients at too high a risk for open mitral valve surgery.
The FDA approval for MitraClip G4 is expected to enhance Abbott's (ABT) cardiac treatment portfolio.
The advisers voted 12-2 in favor of the effectiveness and unanimously backed safety of the device, which is similar to Abbott's older device MitraClip that operates in the upper and lower left ...
Mitral valve repair is a cardiac surgery procedure performed by cardiac surgeons to treat stenosis (narrowing) or regurgitation (leakage) of the mitral valve.The mitral valve is the "inflow valve" for the left side of the heart.
Abbott Laboratories is an American multinational medical devices and health care company with headquarters in Abbott Park, Illinois, in the United States. The company was founded by Chicago physician Wallace Calvin Abbott in 1888 to formulate known drugs; today, it sells medical devices, diagnostics, branded generic medicines and nutritional products.
Abbott Labs announced in a recent press release that its catheter-based MitraClip system, used to treat mitral regurgitation, showed positive results in a trial evaluating its clinical and quality ...
Thoratec Corp. announced that this was the first time the FDA had approved a clinical trial to include both indications in one protocol. [ 49 ] [ 50 ] [ 51 ] A multicenter study in the United States from 2005 to 2007 with 113 patients (of which 100 reported principal outcomes) showed that significant improvements in function were prevalent ...