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Local Biomed Device Aiding NASA

Project Aids Push to Provide Telemedicine for Home Care

CardioDynamics International Corp. is banking on space research to bring its heart device into homes on Earth.

The San Diego-based medical device firm announced Dec. 29 that NASA placed another order for a CardioDynamics heart monitor to research, among other things, the long-term effects of higher levels of gravity on the heart.

The research study is being conducted in concert with UCSD and the University of Pittsburgh, CardioDynamics reported.

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The latest NASA order was for the BioZ.com, the latest of three CardioDynamics’ heart monitors approved for marketing.

Company officials declined to offer details on their agreement with NASA, but said it placed several of its devices in universities for the purpose of clinical studies.

CardioDynamics’ CEO Michael K. Perry said while the firm’s role in the study remains minimal, NASA’s results could have a profound impact for the firm’s year-end objective.

That is to gather sufficient information to seek federal approval for a new device still in development, called BioZ.tel.

If approved, the BioZ.tel would be the first hand-held device on the market that allows patients to measure their blood flow from the heart to the body, the amount of blood pumped by the heart in one minute, the amount of fluid in the chest, blood pressure and heart rate via specialized software and a set of four electrodes placed on the patient’s body. Conventional methods to gather this kind of information require a complicated surgical procedure, Perry said. The BioZ.tel requires no surgery and can deliver the data within minutes.

If approved, the BioZ.tel would mark a milestone for CardioDynamics and telemedicine proponents alike.

“It’s been our vision to miniaturize technology and provide it to patients’ homes,” Perry said.

Proponents of miniaturized technology say it’s cheaper, faster and user-friendly.

So far, the Food and Drug Administration gave the green light for three CardioDynamics’ systems: In 1996 for the BioZ heart monitor, which costs about $25,000; in 1997 for the BioZ portable version; and in May 1998 for the next-generation BioZ.com., priced at about $28,000.

In 1998, CardioDynamics also received federal approval for full Medicare coverage on its BioZ system, an important milestone.

Its newest venture, the BioZ.tel, is targeted for use in the rapidly growing home health care market, a $1 billion industry, according to Perry.

Patient Friendly

The BioZ.tel requires self-use, meaning patients would place the electrodes on the neck and chest and send the recorded data via the Internet or phone to a centralized computer at CardioDynamics’ headquarters, Perry said. Doctors can then access the firm’s server via a password and retrieve a patient’s information.

Perry said the billing process is yet to be determined, but he envisions two models.

In one, patients would obtain the device from CardioDynamics and administer it according to doctor’s orders. CardioDynamics would charge patients a $200 monthly fee, which Perry said should be reimbursed by insurers.

The second possible scenario is that doctors would buy the BioZ.tel for $2,000 and pay CardioDynamics a monthly fee of $100 for its monitoring services. Patients would pay their doctors $200 a month to use the device.

While many logistical questions remain, the question of whether remote monitoring works does not, Perry said.

“If you can monitor at 18,000 feet on Mount Everest, you can do that at a patient’s home,” he said, noting the technology’s success in experimental testing in one of the world’s harshest environments.

The firm’s BioZ portable lab-top device was among several technologies tested for “extreme telemedicine” in a 1998-99 Mount Everest expedition sponsored by Yale University’s School of Medicine in New Haven, Conn., MIT’s Media Lab in Cambridge, Mass., AT & T; and NASA.

High Altitude Research

Expedition leader Dr. S. Vincent Grasso, then a post-doctoral associate with the Department of Surgery at Yale University, said he sought to prove to the world for years that people can be monitored in any environment in the world at any time.

In the study, 10 climbers and non-climbers were treated for minor health problems, including dehydration and altitude sickness, and more serious ones, including emphysema and congestive heart failure brought on by the lack of oxygen at 18,000 feet.

“What happens in altitude is that you can mimic disease processes at sea level,” Grasso said. At 18,000 feet, one-third of the atmosphere is gone, leaving people with a lack of oxygen.

When that happens, Grasso explained, “the more information you can gather, the better you can tailor the care.”

CardioDynamics’ device provided vital information on patients’ heart rate, blood pressure and cardiac output.

He praised the BioZ as measuring and transmitting data flawlessly via satellite to Yale University.

Challenges Ahead

Grasso agreed with Perry that the technology has commercial applications. However, implementing it will not be without challenges, he predicted.

He foresees the biggest obstacles will be jurisdictional and in gaining acceptance from the medical community.

“The technology is not the difficult part, but the bureaucracy, and the medical and legal establishment,” Grasso said.

Many questions remain unsolved. Among them are who can bill for providing health care services over the Internet, how safe is it for patients and who is liable.

Perry said telemedicine is still in its infancy, but not for long.

Grasso, who founded his own firm, TIMA Inc., in New Jersey following the 1998 Mount Everest expedition, and telemedicine proponents like Perry are pushing for acceptance.

Their arguments: Home health care has the potential to eliminate up to $50 billion out of the $400 billion annual hospitalization costs in the United States by reducing patients’ length of stay, invasive procedures and preventing heart disease, CardioDynamics reported.

Perry predicted the earliest the BioZ.tel is likely to enter patients’ home is mid-2001.


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