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News Breaks | | | | March 18, 2013 | | 09:19 EDT |  | ABT | FDA 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 | |
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News For ABT From The Last 14 Days Check below for free stories on ABT the last two weeks. |
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| May 22, 2013 | | 07:28 EDT |  | ABT | UBS to host a conference
Global Healthcare Services Conference is being held in New York on May 20-22 with webcasted company presentations to begin on May 22 at 8 am; not all company presentations may be webcasted. Webcast Link | | | May 21, 2013 | | 08:03 EDT | | ABT | Abbott announces CE Mark for coronary drug eluting stent
 Subscribe for More Information | | | May 20, 2013 | | 10:11 EDT |  | ABT | On The Fly: Analyst Upgrade Summary
Subscribe for More Information | | | 06:01 EDT | | ABT | Abbott upgraded to Buy from Neutral at Goldman
Goldman upgraded Abbott to reflect accelerating growth driven by emerging markets, better growth and product mix, new product launches, and market share gains. Price target raised to $44 from $38. | |
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