|Doesn't mean there isn't need for better drug to send AF patients home on, but I'd have to think this may be mentioned in negotiations to license V in chronic AF.|
Device to treat atrial fibrillation superior-study
Tue Nov 11, 2008 11:06am EST
CHICAGO, Nov 11 (Reuters) - Johnson & Johnson's (JNJ.N: Quote, Profile, Research, Stock Buzz) ablation device outperformed drug therapy for the heart rhythm disorder atrial fibrillation 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 heart rhythm disorder, affecting 2.2 million Americans, and a common cause of stroke.
The NaviStar ThermoCool Catheter, manufactured by J&J's Biosense Webster unit, currently is approved in the United States to treat atrial flutter and a form of recurrent ventricular tachycardia after heart attack.
Currently, there are no ablation catheters approved for marketing by the U.S. Food and Drug Administration for the treatment of atrial fibrillation in the United States. However, some doctors use the device to treat atrial fibrillation.
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 need to consider the panel's recommendation in deciding whether to approval the treatment for atrial fibrillation.
FDA approval would allow the procedure to be promoted specifically for atrial fibrillation.
During cardiac ablation, a catheter is inserted into the heart and energy is delivered through the catheter to those areas of the heart muscle causing the abnormal heart rhythm. The energy disconnects the pathway of the abnormal rhythm.
In the study of 167 people, patients who received catheter ablation treatment showed a 75 percent reduction in recurrence of atrial fibrillation, compared with 21 percent for patients treated with anti-arrhythmic drugs.
"This is the first time in an FDA-monitored, controlled clinical study that catheter ablation has been shown to outperform traditional medical therapy," said Dr. David Wilber, the study's lead author and director of cardiology at Loyola University Medical Center in Maywood, Illinois.
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 serious complications such as death, heart attack or stroke 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. (Editing by Dave Zimmerman)