St. Jude Medical is Warned About Ablation Devices

The U.S. Food and Drug Administration (FDA) has accused St. Jude Medical Inc. of illegally marketing its Epicor surgical ablation devices for off-label use.

FDA officials claim several of the marketing statements made by the St. Paul, Minn.-based company violate the federal Food, Drug and Cosmetic Act. One statement that particularly irked the FDA appeared on St. Jude’s website last year. In that declaration, the company claimed its Epicor system is “designed to safely, effectively and reproducibly create a classic box lesion in a single step,”
according to an April 23 warning letter from the FDA.

FDA officials took issue with that statement because a box lesion is a type of burn that only would be used in atrial fibrillation surgery. The company’s Epicor LP Cardiac Ablation System and Epicor UltraCinch LP ablation device are approved only for general ablation during surgery; to promote the two products for ablation surgery, St. Jude would have to conduct additional, lengthy studies of Epicor.

A spokeswoman for St. Jude Medical told The Wall Street Journal that the company is “working diligently to address the points raised in the warning letter and to resolve the FDA’s concerns.” Executives do not expect the warning letter to affect sales of ablation devices.

The Epicor product line was acquired by St. Jude through the $185 million acquisition of Epicor Medical Inc. in June 2004. Cardiac ablation devices are used to treat a heart rhythm disturbance known as atrial fibrillation (a.k.a., A-fib) by destroying the tissue causing the irregularity. About 25,000 people underwent surgery last year to repair their faulty heart rhythms, according to industry estimates.

While these device generate tens of millions of dollars in sales for companies such as St. Jude Medical, they have not been approved by the FDA to treat atrial fibrillation. Rather, the devices were approved to treat “ablation,” or the destruction of tissue (which historically was done by sealing a wound to stop bleeding).

This discrepancy is the target of an investigation by the U.S. Justice Department. Though doctors often use devices or drugs for off-label treatments, companies are required to market them only for the uses for which they have been approved by the FDA. Such a restricting is meant to limit the number of U.S. patients exposed to experimental, largely untested treatments.

In the last year, the government has won settlements from two surgical ablation device makers over the improper marketing of its products. Estech, a medical device firm based in San Ramon, Calif., agreed to pay $1.5 million last year to settle allegations that it marketed its surgical ablation devices for the unapproved purpose of treating irregular heartbeats. It did not admit any wrongdoing.

AtriCure of West Chester, Ohio, agreed to pay $3.8 million to resolve similar allegations. It also did not admit any wrongdoing.

The Justice Department is investigating St. Jude Medical, Boston Scientific Corp., and Medtronic Inc. over the marketing of their surgical ablation devices.

In addition to the warning letter about its surgical ablation device marketing, St. Jude Medical also received a “civil investigative demand” from the Justice Department related to reimbursements for its implantable cardiac defibrillator products. The request seeks documents related to communications “by and within the company on various indications” for the devices, company officials said in a regulatory filing.