Sleep patients to 'Watch' for disorders with new product
MURRYSVILLE, Pa. - Itamar Medical got FDA approval to begin selling a unique, ambulatory
device that uses two finger probes to measure physiological changes that indicate sleep-related breathing disorders such as obstructive sleep apnea (OSA). Respironics will market the product in the United States.
The Watch_Pat100 measures changes in a person's peripheral arterial tone (PAT), a newly identified physiological signal that reflects blood flow changes in the fingertip. The Watch is worn on the wrist. One probe measures the PAT signal, actigraphy and heart rate; another probe measures oxygen saturation.
The Watch_PAT enters a market for ambulatory sleep testing that Respironics already serves with its Stardust, a lightweight sleep recorder introduced in the spring of 2000. By contrast, the Stardust is more cumbersome technology. A patients has to wear a recorder, a cannula, an oximetry probe and an elastic band around the chest to detect body position.
While the Stardust has not managed to kick open the door to widespread home sleep studies, the Itamar device promises another attempt.
"This is so straightforward. It's so east to use," said John Miclot, president of Respironics' home care division. "As we build the clinical story, our belief is that this could be the next generation of portable diagnostic system."
In late January, Respironics began training its newly created sleep sales organization, which will begin selling the Watch_PAT into the market over the next several months.
"We want to talk to the people who want to get creative about the current model," said Miclot. "To the home care providers, the aggressive sleep labs and the cardiologists."
In the meantime, Respironics is building a "clinical story" to go along with the sales effort.
The FDA has cleared the device as an OSA diagnostic tool. But Respironics believes that clinical evidence will show the device can distinguish between obstructive events, central events and Cheyne-Stokes respirations. Respironics is now running trials that should show that a Watch_Pat study correlates to a full polysomnographic study.
"I think we're going to be able to correlate [the Watch_PAT] to both full polysomnography and any of the other portable diagnostic devices," said Miclot. "What we'll end up with is an ability to take to payers an alternative methodology for looking at OSA."
Today, about 90% of the CPAP patient population is diagnosed in the sleep lab. Although Medicare does not pay for in-home sleep studies, about 85% of the CPAP population belongs to the non-Medicare demographic group. HME