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News Breaks
June 10, 2014
08:16 EDTBCRFDA posts 12-month results of C.R. Bard Levant 2 trial
The FDA posted on its website briefing documents ahead of a circulatory system devices panel meeting scheduled for June 12, where an advisory committee will review C.R. Bard's Lutonix drug-coated balloon PTA catheter. Among the documents posted was C.R. Bard's executive summary, which contains the 12-month results of its pivotal Levant 2 trial. "Freedom from TLR was numerically favorable for the Lutonix DCB group, but no statistical difference between arms in Freedom from TLR rates was observed," the company stated in the summary. Reference Link
News For BCR From The Last 14 Days
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July 24, 2015
16:22 EDTBCROn The Fly: Top stock stories for Friday
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July 23, 2015
17:33 EDTBCRC.R. Bard sees Q3 EPS $2.21-$2.25, consensus $2.28
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17:32 EDTBCRC.R. Bard raises FY15 EPS view to $9-$9.10 from $8.95-$9.05, consensus $9.02
16:29 EDTBCRC.R. Bard reports Q2 adjusted EPS $2.27, consensus $2.18
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15:04 EDTBCRNotable companies reporting after market close
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July 21, 2015
09:27 EDTBCRFDA sent C.R. Bard warning letter after facility inspection
The FDA sent C.R. Bard a warning letter after inspecting the company's Peripheral Vascular facility. The letter stated in part, "FDA is aware that your firm submitted both in-vitro and in-vivo testing demonstrating the use of the Recovery Cone Removal System, Model RC-15 for removal of the Recovery Filter (K031328), the G2X Filter (K082305), the G2 Express Filter (K080668), and the G2 Filter (K073090). However, the Recovery Cone System, Model RC-15 was not included as part of the clearances for any of the aforementioned IVC filters. Therefore, your firm is marketing the Recovery Cone Removal System, Model RC-15 in the United States without marketing clearance or approval. Percutaneous retrieval systems, such as the Recovery Cone Removal System, Model RC-15, are regulated as manual surgical instruments intended for specialized use within a specific medical specialty, and thus require marketing authorization in order to be legally marketed in the United States." Reference Link

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