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CHICAGO, Nov 11 (Reuters) - Johnson & Johnson's (JNJ.N: Quote, Profile, Research, Stock Buzz) ablation device outperformed drug therapy for a common disorder of irregular heartbeats in a study that will be used to seek U.S. regulatory approval for the treatment, J&J said on Tuesday.
Patients who received the catheter ablation treatment were significantly more likely to be free of recurring atrial fibrillation nine months after treatment and had fewer serious side effects after 90 days than those receiving drug therapy, J&J said. The data were presented at a meeting of the American Heart Association in New Orleans.
Atrial fibrillation is the most prevalent form of irregular heartbeat, affecting 2.2 million Americans, and a common cause of stroke. It causes the upper chambers of the heart to quiver rather than pump blood efficiently, which can allow clots to form.
The NaviStar ThermoCool Catheter, manufactured by J&J's Biosense Webster unit, is approved in the United States to treat atrial flutter and a fast heart rhythm known as ventricular tachycardia that sometimes occurs after a heart attack.
Some doctors use the device to treat atrial fibrillation, though the U.S. Food and Drug Administration has not approved any ablation catheter to be marketed for the treatment of atrial fibrillation in the United States.
An FDA advisory panel will review J&J's application for an atrial fibrillation indication for the device at a meeting on Nov. 20. FDA officials then would consider the panel's recommendation in deciding whether to approve the treatment for atrial fibrillation.
FDA approval would allow the procedure to be promoted specifically for atrial fibrillation.
During cardiac ablation, a thin, flexible tube known as a catheter is inserted into the heart, and radiofrequency energy is delivered through its tip to those areas of the heart muscle causing the abnormal heart rhythm. The catheter burns the heart tissue, disconnecting the pathway of the abnormal rhythm.
In the study of 167 people, patients who received ablation treatment showed a 75 percent reduction in recurrence of atrial fibrillation, compared with 21 percent for patients treated with anti-arrhythmic drugs. The trial was the largest to compare ablation to drug therapy in atrial fibrillation patients, and was halted early due to the positive results.
"This is the first evidence that ablation is clearly better than drug therapy. There haven't been any clear-cut signals, except in a couple of small studies," said Dr. David Wilber, the study's lead author and director of cardiology at Loyola University Medical Center in Maywood, Illinois. Wilber is a consultant to the company.
Patients chosen for the study did not respond to at least one type of anti-arrhythmic drug and had at least three atrial fibrillation episodes in the past six months.
The incidence of adverse events in the 90 days following therapy was 18.4 percent for the patients who underwent the ablation procedure, compared with 35.1 percent for those receiving drug therapy. None of the complications caused permanent disability or death in either arm of the study, Wilber said. (Reporting by Susan Kelly, editing by Richard Chang)
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