This article was originally published in The Gray Sheet
Executive SummaryFirm enters "tentative" agreement with the Department of Justice Nov. 4 to settle allegations of illegal off-label promotion of its Isolator cardiac ablation devices for atrial fibrillation treatment. AtriCure proposes to pay $3.8 million, plus interest, over five years and enter into a corporate integrity agreement with the HHS Office of Inspector General. However, AtriCure admits no wrongdoing. The firm's Isolator bipolar ablation system and Coolrail linear ablation device are FDA-cleared for ablating cardiac tissue during surgical procedures, but not specifically for AF. Johnson & Johnson/Biosense Webster's NaviStar ThermoCool catheters remain the only FDA-approved AF ablation catheters on the market. AtriCure was among five companies facing whistleblower lawsuits for off-label promotion of ablation catheters. Medtronic, Boston Scientific and St. Jude Medical are still under investigation, while Endoscopic Technologies settled related allegations in July for $1.4 million (1"The Gray Sheet" July 20, 2009)
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