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Software OKd for Remote Testing of Defibrillators

October 03, 2006|From Bloomberg News

Boston Scientific Corp. said Monday that federal regulators had approved software upgrades that would enable defibrillators implanted in 150,000 patients to send computerized health data to doctors over the telephone network.

The monitoring will eliminate quarterly office visits and allow doctors to remotely confirm that the heart devices' batteries are working, the Natick, Mass.-based company's Guidant unit said. Heart specialists have urged makers of defibrillators, which automatically restart stopped hearts, to expand remote monitoring of the $30,000 devices.

Boston Scientific hopes the free service will help it recover sales momentum lost in 2005, when Guidant recalled 109,000 defibrillators because of battery failures linked to seven deaths. The recall undercut the global defibrillator market, which plummeted from 25% annual sales growth in 2004 to its first decline this year. Experts say home monitoring carries scant risk of patient injury.

"Remote monitoring doesn't allow for reprogramming of the device, so I see little potential for harm," said Dr. William Maisel, a Harvard Medical School cardiologist who consults with the Food and Drug Administration on defibrillators. "We may get to the point where these device checks can be done more frequently than every three months."

Boston Scientific said about 10,000 defibrillator patients were enrolled in its Latitude wireless monitoring program, which began early this year. Computerized data, including weight, blood pressure, device performance and battery status, are transmitted to doctors by telephone and over the Internet while the patient sleeps near a collection device.

"It's a great service to the patients and to us," said Dr. John Seger, a heart implant specialist at Texas Heart Institute in Houston.

Home monitoring allows Seger to explore the defibrillator's memory without requiring the patient to make the inconvenient trip to a downtown hospital, he said.

It also avoids the need for an emergency room examination each time a patient thinks his or her defibrillator may have sent a shock to the heart.

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