FDA 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
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