AtriCure heart device safe, with caveats: FDA staff

AtriCure Inc’s Synergy Ablation System
heart-rhythm device is safe and effective, but its trial size and design raise
some concerns, U.S.
medical device reviewers said.

The latest trial “appears to have succeeded” if
all enrolled patients are considered, Food and Drug Administration researchers
said in documents regarding AtriCure’s device, which treats abnormal heartbeat
in patients requiring open heart surgery.

Some patients in the trial had sudden-onset heart rhythm
problems, meaning they may be healthier than those with more advanced forms of
the heart condition. Excluding those “paroxysmal patients,” the
trials meet neither the safety, nor the effectiveness goals, researchers said.

Atrial fibrillation is the most prevalent heart rhythm
disorder, affecting more than 2 million Americans, and a common cause of
stroke.

AtriCure’s Isolator Synergy ablation system was approved in
2001 to remove soft tissues during general surgery. In 2007 had its indication
updated to allow use for ablation of specifically heart tissue during surgery.

The device helps restore normal heart rhythm in patients
with permanent atrial fibrillation, or abnormal heart rate, who require
open-heart surgery.

Without a specific indication for atrial fibrillation, the
drug maker said it has been prohibited from training physicians to use the
device for treatment of abnormal heart rhythm or to discuss the condition in
any way.

Shares of AtriCure fell in afternoon trading on the Nasdaq, dipping 3 percent
to $11.28, in contrast with the S&P Health Care Equipment Sub-Industry
Index, which rose 1.9 percent.

While such devices are still a relatively small part of the
multibillion atrial fibrillation market, analysts expect it to grow.

(Reporting by Alina Selyukh in Washington)