FDA Issues St. Jude Warning Letter Over Epicor Surgical Ablation Device

A Warning Letter from the U.S. Food & Drug Administration (FDA) to St. Jude Medical Inc. has been posted on the agency’s web site. The letter alleges that St. Jude promoted the Epicor surgical ablation device to treat atrial fibrillation, a use that has not been approved by the agency.

Surgical ablation devices like the Epicor system are approved for “ablation,” or the burning of tissue, to seal a wound to stop bleeding. While doctors are permitted to use medical devices in any way they see fit, manufacturers are legally barred from marketing or promoting such uses. St. Jude has received the go-ahead from the FDA to investigate the Epicor system’s use in treating atrial fibrillation, but not approval to market it for this use.

In a Warning Letter dated April 23, the FDA cited marketing statements such as one on the St. Jude’s website last year that the Epicor system is “designed to safely, effectively and reproducibly create a classic box lesion in a single step.” According to The Wall Street Journal, the statement referred to a pattern of burns imprinted on the heart during atrial fibrillation surgery. The letter said statements like that violated the Federal Food, Drug and Cosmetic Act.

The letter also said the FDA found similar problems with marketing brochures and materials aimed at physicians.

Recently, St. Jude acknowledged an investigation by the U.S. Department of Justice into similar false marketing claims involving Epicor. In its most recent quarterly report, the firm stated that it had received a letter from the Department in October 2008.

In March, we reported that Medtronic Inc. and Boston Scientific Inc. had confirmed that the Department of Justice was investigating their marketing of the devices. Another firm, AtriCure, agreed to pay $3.8 million to resolve allegations it marketed its surgical ablation devices for the unapproved purpose of treating atrial fibrillation.

It is estimated the about 80 percent of atrial fibrillation patients are effectively treated with drugs. Unfortunately, there are few studies available that compare the safety of ablation to other types of atrial fibrillation treatments. Since 2008, there have been at least five U.S. patient deaths reported to an FDA data base in procedures using AtriCure devices and one involving a Medtronic device.