What’s the Worst Case Scenario for AtriCure’s Federal Investigation?
Amanda Pedersen, 20 September 2019
Renewed concerns about a Department of Justice (DoJ) investigation involving a key player in the atrial fibrillation space has prompted one medtech analyst to review similar investigations in the industry.
In March 2018, Mason, OH-based AtriCure, disclosed that it received a civil investigative demand from the DoJ over potential off-label marketing of the company’s Deep hybrid procedure products, which account for about 10% of AtriCure’s total sales. AtriCure’s Deep procedure is not FDA approved to treat atrial fibrillation, but the devices that are used in the procedure have FDA clearances for tissue ablation and the company is currently running a trial to support approval for an atrial fibrillation indication.
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