A federal False Claims Act suit filed in Houston against medical device maker AtriCure Inc. has been unsealed. The suit, similar to others filed against Atricure’s competitors, charges that the company marketed its surgical ablation devices for treatment of atrial fibrillation, a use for which the devices have not been approved by the Food and Drug Administration. The Justice Department is also investigating whether the manufacturer encouraged hospitals to submit claims to Medicare with incorrect billing codes for the surgical ablation in an effort to increase the amount of reimbursement paid by Medicare. The government must decide by August 21 whether to intervene in the suit.
Cardiac ablation is a medical procedure in which an energy source, like ultrasound, is used to deaden a damaged section of heart tissue. Ablation is successful in stopping arrhythmia (irregular heart beat), a condition that may cause chronic fatigue or susceptibility to stroke.
For the full story, go to the Cinncinati Enquirer.