Two companies that make surgical ablation devices have settled whistleblower lawsuits with the government that alleged they marketed the devices for the treatment of atrial fibrillation (AF), which is not an FDA-approved indication, according to a report in the March 11 Wall Street Journal (WSJ).
West Chester, Ohio-based AtriCure will pay the government $3.8 million, while San Ramon, Calif.-based Estech will pay $1.5 million. Both companies did not admit wrongdoing, according to the WSJ.
The suits were filed by Elaine George, a former medical-device saleswoman. George will receive nearly $1 million of the settlement money as the whistleblower.
George also has lawsuits pending against Boston Scientific, Medtronic and St. Jude Medical for allegedly marketing their surgical ablation devices for treating AF. The U.S. Department of Justice is investigating those cases but has not joined the suites. Each company has denied that their top executives approved any illegal marketing, according to the WSJ.
While physicians can use the ablation catheters to treat AF, the companies that make them cannot market them for off-label procedures.