The FDA has sent a warning letter to the atrial fibrillation (AF) division of St. Jude Medical for improperly promoting and marketing its Epicor LP cardiac ablation system and the Epicor UltraCinch LP ablation device in the U.S.
In the letter, dated April 23, the agency said it learned that the company was promoting and marketing these devices in violation of the Federal Food, Drug and Cosmetic Act during an inspection of its facility in Sunnyvale, Calif., on July 9 through July 29, 2009.
The Act defines Epicor LP and Epicor UltraCinch LP as devices intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or are intended to affect the structure or function of the body.
The FDA said it has cleared the Epicor LP under premarket notification, K080292 (which includes the UltraWand LP and UltraCinch LP ablation devices, the ablation control system, connecting cable and accessories), for the “intended use of ablation of cardiac tissue during cardiac surgery.” The FDA also approved St. Jude’s investigational device exemption application for the Epicor LP (including the UltraWand LP and UltraCinch LP ablation devices, the ablation control system, connecting cable and LP positioning and sizing accessory) for the study of a new indication for AF treatment.
However, the agency’s letter said that St. Jude's claims on its website appear to promote “these devices for the treatment of atrial fibrillation” through the company’s references to the box lesion and Maze cardiac lesions, which it “considers…to be synonymous with the treatment of atrial fibrillation.”
That website also states that the Epicor LP "is commercially available for use in the United States,” and according to the FDA, St. Jude has “not obtained marketing approval or clearance before you began offering your product for sale, which is a violation of the law.”
Furthermore, the FDA determined that St. Jude’s activities in its clinical study of the Epicor LP, including the component devices, “failed to comply with applicable federal regulations.”
The agency listed additional, similar offenses on multiple promotional and marketing materials.
As a result, the agency’s Office of Compliance requested that St. Jude “immediately cease the dissemination of promotional materials the same as or similar to that described above for these devices.”