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News Breaks
March 18, 2013
09:19 EDTABTFDA panel says approval 'not appropriate' for Abbott's MitraClip
The FDA posted online a summary for the March 20 meeting regarding Abbott's Vascular MitraClip Clip Delivery System, a first-of-a-kind transcatheter mitral valve repair system. An FDA panel concluded that premarket approval "is not appropriate at this time as major questions of safety and effectiveness, as well as the overall benefit-risk profile for this device, remain unanswered." The FDA said the trial data submitted, while "interesting and important," lack "valid scientific evidence of safety and effectiveness for the MitraClip CDS for the proposed Indication for use in an inoperable MR population." The agency panel went on, "Because there are limited options for high risk inoperable and high risk mitral valve patients, the FDA has recently worked with the sponsor in a highly interactive manner to develop a new U.S. randomized controlled trial for this patient population called the COAPT Trial. In addition, the sponsor has also recently developed a European randomized trial for this patient population." Reference Link
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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