* Device delivers shocks to irregularly beating heart
* Boston Scientific in process of buying Cameron Health
* Recent high-profile safety issues with defibrillators
By Anna Yukhananov
WASHINGTON, April 26 U.S. drug advisers gave the
nod to the first defibrillator designed to be implanted directly
under the skin, raising hopes Cameron Health Inc's novel product
would be approved.
Outside advisers to the U.S. Food and Drug Administration
voted 7-1 to recommend approval of Cameron's device, which
delivers electrical shocks to a dangerously irregular heartbeat
to return it to a normal rhythm. They also voted 7-1 that the
device worked and unanimously said it was safe, according to the
company and the FDA.
The product gained renewed attention after Boston Scientific
Corp, one of the top three makers of heart devices,
agreed in March to buy privately held Cameron Health for $150
million and add another $150 million if the defibrillator gained
Shares of Boston Scientific closed up 0.5 percent at $6.18.
The FDA usually follows panel recommendations, although it
is not required to, and will make a final decision later.
The defibrillator has been available in major European
countries since 2009, with about 1,200 devices sold, the company
Earlier this week, reviewers from the FDA said Cameron's
defibrillator might cause more infections and work less quickly
than similar devices implanted in the heart.
But the FDA staff also said the company met safety and
effectiveness goals during clinical trials.
Cameron Health said about 800,000 people in the United
States are at risk of sudden cardiac arrest, when the heart
suddenly stops beating, making them eligible for an implantable
Like similar devices, Cameron Health's defibrillator, called
the S-ICD, delivers electric shocks to help a fluttering heart
beat normally. But its electrodes are threaded under the skin
along the breastbone, rather than directly into the heart.
In-heart electrodes are known as transvenous leads.
Cameron Health has said its device is easier to implant than
transvenous leads because it does not require an X-ray machine,
and may be safer because it is easier to remove than devices
inside the heart in the event of a problem.
Boston Scientific, Medtronic Inc and St. Jude
Medical Inc all make implantable defibrillators.
During discussions on Thursday, panelists and FDA reviewers
focused on "inappropriate" shocks from the device, when 30.7
percent of patients in clinical trials received an electric
shock to the heart without having an overly fast heart rhythm or
quiver of the heart muscles.
However, about a third of shocks with transvenous leads are
also inappropriate, the FDA said. The leads are the wires that
carry electricity to the heart.
Safety issues with defibrillator leads made headlines
recently, after St. Jude Medical was forced to halt sales of two
of its leads due to concerns the insulation could wear away and
expose the wires.
Kevin Hykes, Cameron Health's chief executive, said the
company was confident doctors would be able to use its device
safely, and is hoping to get a final response from the FDA by
the end of the year.
"Despite some controversy lately, defibrillation therapy is
a life-saving therapy that has changed some lives," he said in
an interview. "(Today) is a big day for Cameron Health, and an
even bigger day for patients."