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November 19, 2008
By: Editor
AtriCure, Inc. received a letter on Oct. 27, 2008 from the US Department of Justice-Civil Division (the “DOJ”) informing the company that the DOJ is conducting an investigation for potential False Claims Act and common law violations relating to the its surgical ablation devices. Specifically, the letter sid the DOJ is investigating the company’s marketing practices utilized in connection with its surgical ablation system to treat atrial fibrillation, a specific use outside the FDA‘s 510(k) clearance. The letter also said the DOJ is investigating whether AtriCure instructed hospitals to bill Medicare for surgical ablation using incorrect billing codes.
The DOJ is now compiling a document request. The company said it intends to cooperate with federal officials during their investigation and operate its business in the ordinary course during the investigation.
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