CDU Washington Editor

WASHINGTON – The FDA has granted clearance to a product that may shock some consumers – literally. Philips Medical Systems (Bothell, Washington) got the nod from the FDA in mid-September to market its HeartStart Home Defibrillator over the counter for the treatment of sudden cardiac arrest (SCA), the first such clearance in the U.S.

The government's decision opens up a new market for Philips and potentially for other automated external defibrillator (AED) manufactures set to follow suit. The FDA made its decision following a favorable recommendation from its Circulatory System Devices Panel at a meeting on July 29. In recent years, defibrillator technology has been available in public places such as stores, airports, planes, schools, sporting arenas and convention centers.

"The thrust of this effort has been to get the technology out there so that it saves lives," Wendy Katzman, business director for the HeartStart home defibrillator, told Cardiovascular Device Update.

Philips has aired infomercials geared toward marketing the HeartStart to patients who obtained a physician's prescription. The FDA cleared the product for sale by prescription in 2002. HeartStart has been available by calling the company. Last month's clearance will allow the company to immediately market the defibrillators online. Philips also plans to sell the device through retailers and in catalogs.

"Now that we have over-the-counter clearance we can really begin discussions with those types of distributors to see what will make the most sense for consumers and where they are going to want to buy this product," Katzman added.

She said the goal was to have the product available through retailers for the year-end holiday season, with a price of around $2,000.

New direct-to-consumer marketing efforts will include television and print spots that are part of Royal Philips Electronics' (Amsterdam, the Netherlands) new overall "Sense and Simplicity" branding advertising campaign. The HeartStart will be one of the products featured, Katzman noted. Ads already have run in The Wall Street Journal and The New York Times. Katzman was unable to comment on the exact size of the market – either in dollars or number of consumers – that Philips Medical expected to target with its marketing efforts, but she said the interest prior to the FDA's clearance had been a strong indicator of substantial future growth.

She said that 30,000 leads were generated in the first six months after Philips released its infomercials for the product on a prescription-use basis. "People are really interested in this topic, and they want to learn more," Katzman said. "We see this as a tremendous market opportunity for Philips when you begin to consider that this could be like having a fire extinguisher in your home or airbags in your home. You can't predict when you will need these."

Through awareness and education, now that the technology will be available without a prescription, people will decide that it is something they want to prepare for, she predicted.

Market analyst Eli Kammerman of Cathay Financial isn't so sure. Kammerman told CBS MarketWatch that consumers most likely to want their own personal defibrillators are those who have had a cardiac arrest episode and want to be better prepared. But, he said, those individuals are more apt to go for implantable cardioverter defibrillators that, unlike the home AEDs, are reimbursable under health insurance.

Kammerman said that with some 90% to 95% of the AED market coming from sales to commercial establishments and government units, the residential market will expand AED sales only slightly until prices for the devices come down, something he sees as likely once such competitors as Cardiac Science (Irvine, California) and Zoll Medical (Chelmsford, Massachusetts) enter the OTC segment, with approvals for their products in that indication anticipated by the fall of 2005.

Prior to clearance of over-the-counter sales, Philips has sold about 5,000 AEDs for patients with a prescription. Deborah DiSanzo, vice president and general manager of Philips' cardiac resuscitation unit, said in July that once the FDA approved HeartStart for use in homes, the company would realize at least 50% annual growth in those sales for the next four years. She said the firm receives about 10,000 defibrillator inquiries a month.

The hand-held HeartStart comes in a bright red case that looks more like a canvas lunchbox than a medical container. The device provides step-by-step audio instructions for placing the pads on a victim's chest and delivering the electronic jolt. To ensure safety, it is designed to analyze the person's heart rate and deliver a shock only if necessary. The device even reminds the user to call 911 emergency services. Also included is a detailed, quick-reference instruction card. The HeartStart performs daily self-tests and beeps when a system needs attention. It features separate settings and pads for pediatric use.

While automated defibrillators have been shown to save lives, they must be used within the very first few minutes of sudden cardiac arrest, and 80% of SCAs occur in homes, according to the American Heart Association (AHA; Dallas). The AHA reports that cardiac arrest is the cause of more than 340,000 deaths in the U.S. each year, more than the combined deaths from breast cancer, prostate cancer, AIDS, house fires, handguns and traffic accidents. About 95% of cardiac arrest victims die, and even when defibrillators are able to save a life, those saved may be brain damaged if their hearts are not restarted quickly enough.

"It is important to recognize that for a substantial percentage of SCA victims, cardiac arrest is the first sign of heart disease," said Jeremy Ruskin, MD, director of the Cardiac Arrhythmia Service at Massachusetts General Hospital (Boston). "We know that access to early defibrillation helps save lives. Removal of the prescription requirement for the HeartStart Home Defibrillator gives people freedom of choice to be better prepared for unexpected cardiac arrest - a rare but life-threatening emergency."

A recent study released in The New England Journal of Medicine found that deploying AEDs in public places and training citizens to use them can double the chances of surviving sudden cardiac arrest for the general population.

Cardiac Science Chairman and CEO Raymond Cohen said following the release of the study that on a worldwide basis, $280 million of AEDs are estimated to have been sold, of which 85% of those dollars are expected to go to the U.S. this year. That equates to about 150,000 devices being sold this year, up from 120,000 last year. A spokesperson for Cardiac Science told CDU last month that the company expected to submit a 510(k) application to the FDA in a matter of weeks for over-the-counter approval of its Powerheart AED G3.

Medtronic (Minneapolis) is another prominent AED maker whose AED activities are centered on its Medtronic Physio-Control (Redmond, Washington) business with its line of Lifepak products.

Nancy Nygren, director of consumer markets for Medtronic Physio-Control, said, "we support removing the prescription requirement." She said the physician prescription "has always been confusing and an artificial barrier to purchase [of AEDs for home availability]. It truly isn't an authorization from a medical indication standpoint, which is what the physicians are familiar with – making a clinical judgment on whether a person should have it or not." Nygren said the company would be filing a 510(k) for its own over-the-counter product "fairly soon." Medtronic Physio-Control's AED for the home market is the Lifepak CR Plus.

Analysts expect the companies that earn over-the-counter clearance for AEDs to work out distribution deals with key retailers, including drug store chains such as Walgreen's and CVS Pharmacies and large discount buying organizations such as Costco and Sam's Club.