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March 20, 2013
19:47 EDTABTFDA advisory committee votes 5-3 in favor of Abbott's MitraClip benefits
Abbott announced that the U.S. Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee has voted Yes: 5, No: 3 that the benefits of treatment with the MitraClip device outweigh its risks in patients with significant symptomatic mitral regurgitation who have been determined by a cardiac surgeon to be too high risk for open mitral valve surgery and in whom existing co-morbidities would not preclude the expected benefit from correction of the MR. On the separate question of whether there is reasonable assurance the device is safe, the panel voted Yes: 8, No: 0. On the question of whether there is reasonable assurance of efficacy, the panel voted Yes: 4, No: 5. The FDA will take into account the panel's advice in making its decision on whether to approve the MitraClip for the treatment of significant MR in the United States. The company expects a decision later this year.
News For ABT From The Last 14 Days
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April 15, 2015
07:41 EDTABTEBD Group to hold a forum
ChinaBio Partnering Forum 2015 is being held in Shanghai, China on April 15-16.
April 14, 2015
09:06 EDTABTAbbott and Sekisui announce collaboration for coagulation testing
Abbott and Sekisui announce an agreement to offer coagulation testing solutions for laboratories worldwide. Coagulation tests measure a person's blood clotting ability, which can help doctors assess risks of excessive bleeding or developing clots. Under the agreement, Abbott will be the exclusive distributor of Sekisui's new CP3000 coagulation instrument in the United States, Europe and other regions that recognize CE Mark.

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