AtriCure Inc., a medical device manufacturer out of West Chester, OH, will be settling with the United States to resolve claims regarding the alleged promotion of its radio frequency surgical ablation devices. The U.S. Department of Justice has announced that the company will pay $3.76 million as part of a civil settlement. Surgical ablation devices use radio frequency or other energies to create controlled lesions or scar tissue on internal organs, such as the heart.

The settlement follows a qui tam or whistleblower lawsuit under the federal False Claims Act. Private citizens (known as relators) may bring lawsuits on behalf of the U.S. government under the Act, and receive part of the settlement or judgment.

According to the publicly available qui tam amended complaint, the company had allegedly been marketing the devices for atrial fibrillation (cardiac arrhythmia). Such use is not FDA-approved. The marketing and sales also allegedly included paying kickbacks to health care providers to use the devices, including products and referrals. Other allegations include encouraging providers to upcode procedures for Medicare reimbursement.

"The misuse of medical devices has the potential of exposing patients to dangerous procedures and taxpayers to payment of unwarranted claims against Medicare," said Tim Johnson, United States Attorney for the Southern District of Texas, in a DOJ press release. "This settlement demonstrates the government's commitment to maintaining safe and affordable health care for its citizens."

David J. Drachman, President and Chief Executive Officer of AtriCure, stated in a company press release, "Moving forward, the men and women of AtriCure have never been more passionate and committed to our mission of improving and preserving human life or more confident in the power of our strategic plan. We believe strongly that AtriCure is uniquely positioned to deliver results for patients, physicians and shareholders."

Read the details:
Adapted in part from press releases from the DOJ, AtriCure.
Links: http://www.justice.gov/opa/pr/2010/February/10-civ-115.html
http://www.atricure.com/News_and_Events/AtriCure_Announces_Definitive_Settlement_with_the_Department_of_Justice_/

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