DoJ probes AtriCure for improper marketing tactics
In a letter dated Oct. 27, the DoJ said it is investigating AtriCure’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, according to the West Chester, Ohio-based company.
The letter also states that the DoJ is investigating whether AtriCure instructed hospitals to bill Medicare for surgical ablation using incorrect billing codes.
AtriCure said it understands that the DoJ is in the process of compiling a document request. The company said it intends to cooperate with the DoJ in its investigation and operate its business in the ordinary course during the investigation.