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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AtriCure, Inc. to Pay U.S. $3.76 Million to Resolve Medicare Fraud Allegations
Biospace, 03 February 2010
WASHINGTON, Feb. 2 /PRNewswire-USNewswire/ — Atricure Inc., a medical device manufacturer, has agreed to pay the United States $3.76 million to resolve civil claims in connection with the alleged promotion of its surgical ablation devices, the Justice Department announced today. Surgical ablation devices use focused energy to create controlled lesions or scar tissue on a patient’s heart or other organs.
“This settlement reflects our commitment to enforce the Food, Drug, and Cosmetic Act and protect Medicare from the improper marketing practices of Atricure and other medical device manufacturers,” said Tony West, Assistant Attorney General for the Civil Division of the Department of Justice. “We will continue to work with our partners at the Department of Health and Human Services Inspector General’s Office and the FDA Office of Chief Counsel to preserve the integrity of our public health programs.”
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The Brualdi Law Firm, P.C. Announces Class Action Lawsuit Against AtriCure, Inc.
The Brualdi Law Firm, 19 December 2008
NEW YORK, Dec. 19, 2008 (GLOBE NEWSWIRE) — The Brualdi Law Firm, P.C. announces that a lawsuit has been commenced in the United States District Court for the Southern District of Ohio on behalf of purchasers of AtriCure, Inc. (“AtriCure” or the “Company”) (Nasdaq:ATRC) securities during the period between May 10, 2007 and October 31, 2008 (the “Class Period”) for violations of the federal securities laws.
No class has yet been certified in the above action. Until a class is certified, you are not represented by counsel unless you retain one. If you purchased AtriCure common stock during the Class Period, and wish to move the court for appointment of lead plaintiff, you must do so by February 10, 2009. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. The lead plaintiff will be selected from among applicants claiming the largest loss from investment in the Company during the Class Period. You do not need to seek appointment as a lead plaintiff in order to share in any recovery.
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AtriCure, Inc. Announces Investigation by the Department of Justice
BioSpace, 03 November 2008
WEST CHESTER, Ohio–(BUSINESS WIRE)–AtriCure, Inc. (Nasdaq: ATRC – News), received a letter on October 27, 2008 from the U.S. 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 Company’s surgical ablation devices. Specifically, the letter states that 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 Federal Food and Drug Administration’s 510(k) clearance. The letter also states that the DOJ is investigating whether AtriCure instructed hospitals to bill Medicare for surgical ablation using incorrect billing codes.
The Company understands that the DOJ is in the process of compiling a document request. The Company intends to cooperate with the DOJ in its investigation and operate its business in the ordinary course during the investigation.
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