The FDA has issued a warning letter to St. Jude Medical for illegally promoting its Epicor ablation device for heart surgery--a use for which the device has not been approved.
The device is used to burn tissue to close wounds and stop bleeding. In marketing statements, St. Jude said the device could "safely, effectively and reproducibly create a classic box lesion in a single step." The FDA took issue with that statement because a box lesion is a type of burn that would only be used in atrial fibrillation surgery. Epicor is approved only for general ablation and to advertise for atrial fibriliation surgery, St. Jude would have to conduct additional, lengthy studies of Epicor. A spokesperson for St. Jude said the company is "working diligently to address the points raised in the warning letter and to resolve the FDA's concerns."
- read the WSJ report for more