The FDA has granted Biosense Webster pre-market approval (PMA) for an atrial fibrillation (a-fib) indication for its ThermoCool Catheter.
The agency’s Circulatory System Devices Advisory Panel will review the application today in Gaithersburg, Md.
The company submitted the PMA supplement based on study data presented at the AHA Scientific Sessions. The study, led by David Wilber, MD, director of the Cardiovascular Institute at Loyola University Stritch School of Medicine in Maywood, Ill., included 159 patients at 19 centers, including 15 centers in the U.S.
In the study, 103 patients with frequent episodes of a-fib were randomly assigned to undergo ablation and 56 similar patients were randomly assigned to receive drug therapy. All patients had experienced at least three episodes of a-fib during the previous six months and had failed at least one attempt to control the rhythm with drugs, according to Wilber.
“This is the first time in an FDA-monitored, controlled clinical study that catheter ablation has been shown to outperform traditional medical therapy,” said Wilber. “These data are extremely important to the electrophysiology community widely adopting alternative treatments to traditional medical therapy, which can often cause significant side effects for patients suffering from this debilitating condition.”
In addition to his role as primary investigator, Biosense compensated Wilber for his services as a member of the company’s scientific advisory board and provides other consulting services.
Currently, there are no ablation catheters approved for marketing by the FDA for the treatment of a-fib in the U.S.