FDA Issues Warning Letter to St. Jude Medical Inc Regarding Surgical Ablation Devices
The FDA recently issued a warning letter to St. Jude Medical Inc regarding its Epicor surgical ablation device. Systems like Epicor are approved for ablation, or the burning of tissue to seal a wound to stop bleeding. It was alleged that St. Jude was promoting the Epicor system to treat a condition known as atrial fibrillation, or abnormal heart rhythm, which had not been approved by the regulatory agency.
Doctors are permitted to use these medical devices in any way they see fit, but manufacturers are legally barred from promoting these products for uses that are not approved. The FDA has not approved atrial fibrillation as a usage of the device.
Other medical device manufacturers, such as Medtronic, Boston Scientific and AtriCure have had trouble with federal regulators in the past over inappropriate marketing of surgical ablation devices. AtriCure previously agreed to pay $3.8 million to resolve allegations it had inappropriately marketed surgical ablation devices.