Forget a digital camera or an iPod. What really would make Carol Emanuel happy is finding a defibrillator in her stocking this Christmas.

Daniel Marsula, Post-Gazette

But with a retail price of $1,495, it's not a gift the Westmoreland Regional Hospital educator is expecting -- even though she's convinced the lunch box-size device that can jump-start a still heart can make the difference between life and death. She even bought one for her dad for Father's Day in 2003.

It used to be that consumers wanting a so-called at-home automated external defibrillator -- AED for short -- needed a doctor's order. But that changed in September when the Food and Drug Administration cleared the Philips HeartStart Home Defibrillator for over-the-counter sales. Philips is marketing the device on Amazon.com, where it is listed this holiday season as one of the "most wished for" home and personal care products -- alongside a device for grooming nose hair.

While at least two other manufacturers of defibrillators are looking to sell the machines over the counter, the idea remains controversial in medical circles, where doctors say the public health benefits of household use have yet to be proven.

From a business perspective, though, it's an example of medical device makers following their pharmaceutical brethren's lead in trying to push products directly to consumers despite what medical experts say.

"They're looking to expand that market into all the houses and homes out there," said Charlie Whelan, an industry analyst with Frost & Sullivan, a New York market consulting company. "There are more and more device companies that are marketing directly to consumers," though most, he said, draw the line at devices they believe are appropriate for patient use -- "you're not going to market a heart-lung machine directly to a patient."

In Pittsburgh, the spread of AEDs has been promoted for years by the National Center for Early Defibrillation at the University of Pittsburgh. The center, partly funded by manufacturers, has supported the placement of machines in airports, malls and office buildings throughout the region.

While AED training is recommended, the machines are designed to be used by anyone. Voice prompts and a digital display provide simple instructions on how to use the heart-starting machines, which analyze the type of cardiac arrest a patient is suffering.

An AED will jolt only those patients with the sort of heart arrhythmias that respond to shock, said Mary Newman, executive director of the center. So, there shouldn't be any inadvertent shocking around the Christmas tree.

"We think it will lead to saving lives," Newman said of over-the-counter AED sales, which she testified in support of during an FDA hearing this summer. "A prescription is written for a patient. But in the case of cardiac arrest, you don't know who the patient will be."

The idea is for consumers to regard AEDs much as they would a smoke detector or fire extinguisher, said Wendy Katzman, business director for the company's in-home AED program, which is based in Seattle. Viewed as a device for public safety, the machine is important not just for the homeowner who buys it but for anyone who enters the home, she said.

Cardiac Science, a defibrillator maker based in Irvine, Calif., is planing to seek FDA approval to sell its product over the counter, as is Medtronic, a competing manufacturer based in suburban Minneapolis that makes the LifePak machine. Medtronic currently sells an AED kit, which includes both the machine and a means for obtaining a physician prescription, through Costco.com, Walgreens.com and SamsClub.com.

While people with a history of heart problems are the most obvious target market for the machines, the over-the-counter market includes people who are at-risk and don't know it, said Nancy Nygren, director of consumer marketing for Medtronic. "The fact is, over half the people who have sudden cardiac arrest have no prior heart symptoms," she said.

But that's where Dr. Arthur L. Kellermann takes up his critique of both over-the-counter AED sales, and the broader trend of direct-to-consumer marketing of devices.

If ever there was a time for manufacturers pursuing this strategy to take pause, it would be this week, Kellermann said, citing revelations about the health risks of the arthritis medication Celebrex. Demand for Celebrex -- and the similar drug Vioxx that was pulled from the market this fall -- was stoked by heavy promotion to consumers.

"Given that people care desperately about their health and respond very well to fears, [advertising] can be a very powerful medium for moving a product," said Kellermann, an emergency physician at the Emory University School of Medicine in Atlanta. "Once you get around the physician as a filter for that information -- someone who can put it into context -- then it's the company and the consumer, and no one to interpret the information in between."

Kellermann agrees that AEDs can save lives in settings such as casinos and airplanes. But what hasn't been proven is that widespread deployment of the machines in homes will, in fact, save lives.

In fact, Kellermann wonders whether home use would bring with it unintended consequences. Life-saving opportunities could be missed because family members don't call 9-1-1 and instead really on a home machine that either can't be found or hasn't been maintained, he said.

"For patients at significant risk for sudden cardiac death, an implantable defibrillator makes more sense because it operates itself automatically," Kellermann wrote in an editorial published in November in the Annals of Emergency Medicine. "For the rest of us, the odds that we will ever need a defibrillator are quite small. If that time comes, the odds that someone will be nearby and know where the AED is kept are smaller still."

Whatever the pros and cons from a social perspective, the business case isn't making Wall Street take notice -- yet, said Tom Gunderson, an analyst for Piper Jaffray in Minneapolis. The regional brokerage firm makes a market in Medtronic, which derived about 4 percent of its nearly $10 billion in annual sales from AEDs during the most recent fiscal year, Gunderson said.

"The market for AEDs is depressed" at that $1,500 price, he said. "There's probably more people who are going to see extreme makeovers under the Christmas tree."