Cardiac Science Receives Canadian Regulatory Approval to Market Fully-Automatic Public-Access Defibrillator
20 May 2005 - 4:30PM
PR Newswire (US)
Cardiac Science Receives Canadian Regulatory Approval to Market
Fully-Automatic Public-Access Defibrillator 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), 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(R)
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. About Cardiac Science Cardiac
Science develops, manufactures and markets a complete line of
Powerheart(R) brand, automatic public access defibrillators (AEDs),
and offers comprehensive AED/CPR training and AED program
management services that facilitate successful deployments. The
company makes the Powerheart(R) CRM(R), the only FDA-cleared
therapeutic bedside patient monitor that instantly and
automatically treats hospitalized cardiac patients who suffer
life-threatening heart rhythms. Cardiac Science also manufactures
its AED products on a private label basis for other leading medical
companies such as Nihon Kohden (Japan), Quinton Cardiology Systems
and GE Healthcare. For more information please visit
http://www.cardiacscience.com/ or call (949) 797-3800. This press
release includes forward-looking statements. These statements may
be identified by the use of forward-looking terminology such as
"anticipate," "believe," "continue," "could," "estimate," "expect,"
"intend," "may," "might," "plan," "potential," "predict," "should,"
or "will," or the negative thereof or other variations thereon or
comparable terminology. Cardiac Science has based these
forward-looking statements on the current expectations,
assumptions, estimates and projections. While Cardiac Science
believes Canadian HCTPD approval will lead to future purchases of
AEDs, these expectations, assumptions, estimates and projections,
while reasonable, are forward-looking statements and are only
predictions and involve known and unknown risks and uncertainties,
many of which are beyond our control. Certain factors, including
those discussed in Cardiac Sciences' Annual Report on Form 10-K for
the year ended December 31, 2004, under the heading "Risk Factors,"
may cause the actual results, performance or achievements to differ
materially from any future results, performance or achievements
expressed or implied by these forward-looking statements. Given
these risks and uncertainties, you are cautioned not to place undue
reliance on such forward-looking statements. We do not undertake
any obligation to update any such statements or to publicly
announce the results of any revisions to any such statements to
reflect future events or developments. Contact: Matt Clawson
(Investors) Michael D. Gioffredi Allen & Caron Inc Chief
Marketing Officer (949) 474-4300 Cardiac Science, Inc. (949)
797-3800 DATASOURCE: Cardiac Science, Inc. CONTACT: Investors, Matt
Clawson of Allen & Caron Inc, +1-949-474-4300, , for Cardiac
Science, Inc.; or Michael D. Gioffredi, Chief Marketing Officer of
Cardiac Science, Inc., +1-949-797-3800, Web site:
http://www.cardiacscience.com/
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