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News Breaks
June 12, 2014
19:37 EDTBCRC.R. Bard receives favorable recommendation from FDA panel for Lutonix DCB
C. R. Bard announced that the FDA Circulatory System Devices Advisory Panel provided a unanimous favorable recommendation to FDA for use of the Lutonix Drug Coated Balloon PTA Catheter, or DCB, in the U.S. The Lutonix DCB is currently under review by FDA for improving luminal diameter and reducing the incidence of restenosis for the treatment of obstructive de novo or non-stented restenotic lesions in native femoropopliteal arteries with reference vessel diameters of 4 mm to 6 mm. If approved, it is expected that the Lutonix DCB will be the first and only FDA-approved DCB available in the U.S.
News For BCR From The Last 14 Days
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November 26, 2014
14:28 EDTBCRMedtronic agrees to divest Covidien drug-coated balloon catheter business
Medtronic (MDT) has agreed to divest the drug-coated balloon catheter business of Covidien (COV) in order to settle Federal Trade Commission charges that its $42.9B acquisition of Covidien would likely be anticompetitive. Under the FTC’s proposed settlement, Medtronic will sell the drug-coated balloon catheter business to medical device company Spectranetics (SPNC), the FTC announced. According to the FTC’s complaint both Medtronic and Covidien are developing drug-coated balloon catheters to compete with C.R. Bard (BCR), which currently is the only company that supplies these products, used to treat peripheral artery disease, in the U.S. market. Medtronic and Covidien are the only companies with products in clinical trials in the Food and Drug Administration’s approval process, which makes it unlikely that other competitors could enter the market in time to counteract the effects of the merger, the FTC alleges. The Commission vote to accept the proposed consent order for public comment was 5-0. The FTC will publish the consent agreement package in the Federal Register shortly. The agreement will be subject to public comment for 30 days, beginning today and continuing through December 29, after which the Commission will decide whether to make the proposed consent order final.

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