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Off-Label Use of Medical Devices: Out of Bounds

By Anita Slomski // SUMMER 2010
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The Food and Drug Administration doesn’t regulate how physicians practice, so physicians are free to use medical devices for purposes other than those for which the technology was approved. Indeed, such off-label applications are common. The first metal stents, approved by the FDA to hold open bile ducts obstructed by tumors or inflammation, soon found a far more widespread use—keeping coronary arteries from collapsing after balloon angioplasty. But the FDA draws the line at marketing medical devices for nonapproved uses.

Manufacturers who suggest to physicians and hospitals that their products have additional, if unsanctioned, uses can find themselves in serious trouble—even when the application has been broadly accepted by the medical community. In February, for example, the U.S. Justice Department announced that devicemaker AtriCure had agreed to pay $3.76 million to resolve allegations that it had promoted its surgical ablation devices, which use radio frequency waves to stop a wound from bleeding, as a treatment for the abnormal heart rhythm atrial fibrillation. That fine comes even though cardiologists have employed such devices for that purpose for 20 years. Another maker of ablation devices, Estech, paid $1.4 million in a settlement after similar allegations, and in April the agency issued a warning letter to St. Jude Medical that its marketing materials promoting an ablation device to treat AF were in violation of the law.

That’s not just bureaucratic foot-dragging, says Mitchell W. Krucoff, co-director of the Cardiovascular Devices Unit at the Duke Clinical Research Institute. “If a device is used in patient populations that haven’t been studied, unexpected things can happen,” Krucoff says. And while surgical ablation devices enjoy a thriving off-label market, evidence of safety and efficacy is lacking. “At present very limited data establishing the long-term impact of catheter or surgical AF ablation on major morbidity and mortality are available,” says a consensus statement from the Heart Rhythm Society.

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