Cardiac Science Receives Canadian Regulatory Approval to Market Fully-Automatic Public-Access Defibrillator
Yahoo Finance
May 20th, 2005
Fully-Automatic Powerheart(R) AED Only Requires
Attachment to Victim to Provide Lifesaving Treatment
IRVINE, Calif., May 20 /PRNewswire-FirstCall/ --
Cardiac Science, Inc. (Nasdaq: DFIB - News), a leading
manufacturer of live-saving public-access defibrillators
(AEDs), today announced that it has been granted approval
by the Canadian Regulatory Agency, Health Canada Therapeutic
Products Directorate (HCTPD), to begin marketing its
patented fully-automatic Powerheart® public-access
AED in Canada.
The Powerheart G3-Automatic which was previously
510(k) approved for sale in the United States by the
U.S. Food and Drug Administration (FDA) in 2004, is
the first fully-automatic AED in the Powerheart product
line and is designed specifically for use in public
places, workplace settings and in-home use by consumers.
In order to use the G3-Automatic, a rescuer need only
listen to the Powerheart's detailed voice instructions
explaining how to attach the device to the heart attack
victim. There are no buttons to push or additional
action required since the Powerheart analyzes the
patient's condition to detect a life-threatening heart
rhythm and, if appropriate, automatically delivers
a potentially lifesaving defibrillation shock(s) to
restore the heart to a normal rhythm.
Cardiac Science Chief Marketing Officer Michael Gioffredi
said, "Since its launch in the U.S. market last
year, the Powerheart G3-Automatic has been our most
popular AED for the public-access marketplace where
ease of use and self-testing capabilities have been
the primary drivers fueling customer acceptance."
Gioffredi continued, "We are currently shipping
our semi-automatic Powerheart G3 AED product to our
distribution partners in Canada, and this regulatory
clearance expands the marketing opportunities for
Cardiac Science, providing those distributors with
an AED product that is easily differentiated from
our competitors."
According to the Canadian Heart and Stroke Foundation,
cardiovascular disease accounts for more deaths in
Canada than any other disease.
About Health Canada, Therapeutic Products Directorate
(HCTPD)
HCTPD, the Canadian medical products regulatory authority,
acts independently of the U.S. Food and Drug Administration.
FDA approval alone does not qualify a medical device
for importation into Canada. Before medical devices
can be legally supplied in Canada, medical devices
are subject to rigorous review, and manufacturers
are obligated to provide evidence to establish quality,
safety and efficacy of their device, as well as the
standard of manufacture of the goods, for review by
HCTPD, prior to approval. |
