Last year, about 25,000 people underwent surgical ablation to treat a common cardiac rhythm disturbance known as atrial fibrillation, even though the devices used for this procedure have not been approved by the FDA for this purpose.
The market for ablation devices exceeds $100 million a year. They are nearly always used to treat atrial fibrillation, rather than the indication for which they were approved, which is to seal-off bleeding during surgery.
In atrial fibrillation, electrical abnormalities cause the upper chambers of the heart to quiver rather than pump normally. The resulting inefficient blood flow allows blood to pool and form clots in the heart, which can cause a stroke or other complications. The syndrome can also be associated with dizziness and shortness of breath.
Atrial fibrillation affects 2.3 million Americans.
Medical device companies would have to conduct expensive clinical trials to secure FDA approval for their devices as treatments for atrial fibrillation.
The Department of Justice is investigating whether companies that make ablation devices violated any laws by marketing them for non-FDA-approved uses like atrial fibrillation. Physicians can use drugs or devices as they please, but companies can only market them for FDA-approved uses.
So far, Justice has won settlements from 2 surgical-ablation device-makers. “The misuse of medical devices has the potential of exposing patients to dangerous procedures,” said Tim Johnson, US Attorney for the Southern District of Texas, after settling with AtriCure Inc. in January.
AtriCure, paid $3.8 million and another company, Estech, paid $1.5 million to resolve the claims. Neither company admitted wrongdoing.
“Clinical trials are needed to define the safety and efficacy of various surgical tools and techniques” used to treat Atrial Fibrillation, according to the Heart Rhythm Society.