* FDA advisors recommend approval in 7-5 vote
* Some panelists still questions safety, effectiveness
* Panel says more study needed if approved
(Adds comments from panel, background on device)
By Susan Heavey
WASHINGTON, April 23 A U.S. Food and Drug
Administration advisory panel on Thursday narrowly backed
Atritech Inc's experimental device to prevent strokes in
patients with irregular heart beat.
In a 7-5 vote, the FDA panel of outside experts said the
device, called the Watchman, should be approved despite some
lingering concerns over some of the data as well as possible
The privately held device maker is seeking U.S. approval to
market its coin-sized, cage-like device as a competitor to the
widely used blood-thinning drug warfarin. It aims to prevent
harmful blood clots that can enter the blood stream and cause
stroke in patients with abnormal heart beat, or atrial
If its device is successful, the Minnesota-based company
could become an acquisition target by larger medical technology
companies, some stock analysts have speculated.
Warfarin, available as a generic and as Bristol-Myers
Squibb Co's (BMY.N) branded drug Coumadin, is relatively
inexpensive but can cause significant bleeding risk and
patients must be frequently monitored. Several drugmakers,
including Johnson & Johnson (JNJ.N) and Bayer AG's BAYG.DE,
are also developing alternatives.
Norman Kato, a panelist and California-based physician,
said he voted in favor of Atritech's device "with a lot of
"I still am very, very concerned about the small sample
size" of patients in the company's clinical trial, he added.
While Atritech studied 707 patients with atrial
fibrillation -- 463 were given the Watchman and 244 patients
given warfarin -- millions more could eligible for it in the
wider marketplace, Kato and others panel members noted.
About 2.2 million Americans have the heart rhythm disorder,
according to the American Heart Association.
If the FDA were to approve the device, panelists urged the
agency to require the company to conduct longer follow-up
studies for up to five years and takes steps to ensure surgeons
are properly trained.
Atritech's expandable device ranges from the size of a
penny to a half-dollar coin and is inserted near the heart's
left atrial appendage where most clots are formed, according to
Panelists said previously released data from a
company-sponsored trial showed the Watchman comparable to
warfarin but noted the potential for surgical-related
complications and other safety issues.
The FDA will weigh the panel's vote before making its final
approval decision. It usually, but not always, follows the
recommendation of its outside experts.
(Reporting by Susan Heavey; editing by Richard Chang)