Tuesday February 5, 1:30 am Eastern Time
Press Release
SOURCE: Cardiac Science, Inc.
Cardiac Science Receives FDA 510(K) Approval to Market Its New-Generation Automated External Defibrillator
Powerheart(R) AED Alleviates Need for Rescuer to Make Clinical Determinations in Cardiac Arrest Incidents; Paves Way for Broader Public Access and Use of AEDs
IRVINE, Calif., Feb. 5 /PRNewswire-FirstCall/ -- Cardiac Science, Inc. (Nasdaq: DFIB - news) today announced that the U.S. Food and Drug Administration has granted the Company 510(k) clearance to market its new Powerheart® AED (automated external defibrillator), designed to be the easiest to use and most technologically advanced public access defibrillator for the emergency treatment of victims of sudden cardiac arrest. The Company has begun commercial shipments to customers in the U.S. and distributors around the world.
Powerheart AED represents a considerable leap forward in the science and usability of public access defibrillators and FDA clearance paves the way for broad deployment of the new life-saving device to combat sudden cardiac arrest, the number one killer of Americans while they are at home, work or play, accounting for over 250,000 deaths each year.
The new Powerheart AED incorporates for the first time into an AED, Cardiac Science's patented RHYTHMx technology, which powers its Powerheart CRM(TM) fully-automatic hospital bedside monitor-defibrillator, making the new AED device highly accurate in the detection and treatment of patients suffering life-threatening abnormal heart rhythms and providing for new capabilities and expanded applications.
As a result, the Company has been granted FDA clearance for new indications for use which include the elimination of the need for the rescuer to determine whether or not the cardiac arrest victim has a pulse prior to attaching the defibrillator device. The Powerheart AED is also cleared for continuous monitoring of a conscious victim's heart rhythm after they have been revived, thereby protecting the victim against the reoccurrence of a post-resuscitation life-threatening arrhythmia, until they can be admitted to a hospital.
Cardiac Science President and CEO Raymond W. Cohen said, ``Our intent in developing this new generation device was to make the use of an AED as easy and unimposing as possible for first responders or good Samaritans who are already facing the stress and urgency of a having to attempt to save the life of stricken coworker, customer, loved one, or stranger suffering a massive heart attack. What Cardiac Science brings to market today, we believe, is by far, the easiest product to use and first AED truly suited for public access deployment.''
Designed to quickly and easily provide a life-saving defibrillation shock to restore normal heart rhythm to a cardiac arrest victim, AED's are being used by first responders such as police, fire and ambulance personnel, and are also being widely deployed at places where people gather or work, such as airplanes, airports, train stations, corporate offices, factories, schools, shopping malls, stadiums, restaurants, casinos and federal, state, municipal government buildings as well as commercial office buildings.
Cohen also said, ``The public access defibrillation market is surging based on the convergence of legislative action and public awareness related to the treatable nature of cardiac arrest. We believe that Cardiac Science has clearly taken the lead in technology development of AEDs and the conversation in the market will quickly shift toward a recognition that it is the brains in the box, and ease of use that count most in a buying decision. Based on the strength of this new product, the recent expansion of our domestic AED direct sales force, which we doubled to 36 representatives, as well as our strong international distribution channels, we believe Cardiac Science is poised to increase its market share beyond the 20 percent we currently hold.''
About the Powerheart® AED
The Powerheart AED also includes patented RescueReady® features found in its predecessor device, the Survivalink® AED, such as one-button operation, pre-connected disposable pads, automatic self-test and escalating variable low-energy biphasic defibrillation technology. New capabilities further distinguished it from its competition -- Powerheart AED is the only AED that differentiates between shockable life-threatening ventricular arrhythmias (VT/VF) and other non-shockable cardiac arrhythmias events such as supraventricular tachyarrhythmias (SVT) and allows for cardioversion, when possible, by automatically synchronizing shock delivery with the patient's electrocardiogram R wave.
It has the ability to continuously analyze a victims heart rhythm after charging and during CPR and is capable of sensing a change of rhythm after a shock decision has been made (commitment to shock) up until the time the shock button is pushed by the user. Upon recognition of a rhythm change, the Powerheart AED (if armed) automatically disarms, informs the user that that the rhythm has changed, and re-analyzes the victims heart rhythm. In addition, post-resuscitation monitoring of the victims' heart rhythm allows the Powerheart AED to instantly detect the reoccurrence of a life-threatening arrhythmia. If cardiac arrest recurs, the device will charge automatically and advise the operator to deliver a defibrillation shock. Powerheart AED also facilities easy medical oversight. Algorithm detection criteria and biphasic defibrillation energy schemes are programmable by qualified medical personnel via the device's removable PCMCIA data card and proprietary MDLink® software.
About Sudden Cardiac Arrest and the Public Access Defibrillator Market
Cardiac arrest takes a tremendous toll on the American public, killing more than 450,000 people annually. Defibrillation is the only effective treatment for sudden cardiac arrest. Currently, a person who suffers sudden cardiac arrest outside of a hospital has only around a 5 percent chance of surviving. Ninety percent of cardiac arrest victims who are treated with a defibrillator within one minute of arrest can be saved, but every minute after the initial onset that a person goes without treatment decreases their chance of survival by 10 percent. At this time, however, few communities have programs to make emergency defibrillation widely accessible to cardiac arrest victims. AEDs have a 97 percent success rate in terminating ventricular fibrillation, yet fewer than half of the nation's ambulance services, less than 15 percent of emergency service fire units, and less than two percent of police vehicles are equipped with AEDs.
A host of AED-related bills, currently being introduced at the federal level and in state governments across the nation, will likely have a positive impact on Frost and Sullivan's annual AED market projections that currently range from $140 million in 2000 to $650 million in 2006.
The first of the bills, the Cardiac Arrest Survival Act (HR 2498) which directed the placement of AEDs in federal buildings around the nation and provides nationwide Good Samaritan protection that exempts from liability anyone who renders emergency treatment with a defibrillator in an attempt to save a persons life, was passed by the United States Congress in November 2000. A companion bill, the Rural Access to Emergency Devices Act, authorized $25 million in federal funds to help rural communities purchase AEDs and to provide training in how to use them. More recently, the Community Access to Emergency Defibrillation Act of 2001 was introduced into the House of Representatives in December. The bill earmarks $55 million a year for five years for communities to buy AEDs and establish access to defibrillation programs.
Recently, the Occupational Safety and Health Administration (OSHA) issued a Technical Information Bulletin and information resource outlining the potential benefits of workplace AED Programs. OSHA will distribute this information to more than 125 trade, professional and union organizations. These documents can be accessed via the Internet at osha.gov .
About Cardiac Science
Cardiac Science develops, manufactures and markets life-saving automatic external cardiac defibrillator devices and proprietary disposable defibrillator electrode pads that monitor and treat patients who suffer life-threatening heart rhythms.
In December, the Company gained FDA clearance for its low-cost, second generation defibrillator-monitor, the Powerheart® Cardiac Rhythm Module, a patented fully-automatic bedside defibrillator-monitor that continuously monitors hospital patients at risk of sudden cardiac arrest, instantly detects the onset of a life-threatening tachyarrhythmia, and, when appropriate, delivers defibrillation shocks within seconds and without human intervention to convert the heart back to its normal rhythm.
Powerheart® CRM, Powerheart® AED and Survivalink®-brand automated external defibrillators (AEDs) along with Artema®-brand emergency defibrillators and patient monitoring products are marketed in the United States by its 45-person direct sales force and by international distributors in more than 40 countries around the world. For more information, please visit www.cardiacscience.com . For investor information please visit www.allencaron.com .
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Cardiac Science cautions that these statements are subject to substantial risks and uncertainties and are qualified by important factors that could cause actual results to differ materially from those reflected by the forward-looking statements and should not be relied upon by investors when making an investment decision. Information on these and other factors is detailed in the Company's Form 10-K for the year ending December 31, 2000 and other documents filed by the company with the Securities and Exchange Commission.
For further information, please contact: investors, Matt Clawson, matt@allencaron.com, or media, Lynn Johnson, or Len Hall, len@allencaron.com, all of Allen & Caron Inc, +1-949-474-4300, for Cardiac Science, Inc.; or Michael Gioffredi, VP Sales & Marketing of Cardiac Science, Inc., +1-949-587-0357, mgioffredi@cardiacscience.com.
SOURCE: Cardiac Science, Inc. |
