CareFusion Jumps into Sleep Diagnostics

Jeffory Wyscarver, marketing manager at CareFusion in Yorba Linda, Calif, believes the NOX-T3 portable sleep monitor could add fuel to a promising new year.

After spinning off from Cardinal Health’s clinical and medical products business in late 2009, San Diego-based CareFusion Corporation continues to build momentum. Thanks to a strategic partnership with Icelandic company NOX Medical, company officials say the mission to diagnose the legions of undiscovered sleep apnea patients is now within their grasp.

Wyscarver has made it one of CareFusion’s missions to diagnose patients who suffer the effects of obstructive sleep apnea, (OSA). The challenge now, he says, is attracting the reluctant (and less obvious) patients who want little or no part of in-lab, overnight studies. Wyscarver and others believe home sleep testing can fill those gaps without threatening the financial livelihood of sleep laboratories.

Growing a Sleep Lab’s Business

Can home testing actually grow the sleep lab business? For Wyscarver, the answer is an enthusiastic yes. The scenario might go something like this: a prospective patient calls a sleep doctor and relays a sleep complaint which coincides with a number of comorbidities such as congestive heart failure or morbid obesity. With these types of comorbidities, the physician will likely send the patient directly to a full sleep lab rather than have the test performed in the home. “Home testing, which is what the sleep labs are most afraid of, is something that is going to benefit them,” says Wyscarver. “When the message gets out that the sleep test can be done in the home, a lot more people who suffer from mild and medium sleep disorders are going to pick up the phone. We are convinced that home sleep testing will grow the in-lab hospital market.”

Opening the Bottleneck

When he joined CareFusion, Wyscarver worked hard to get NOX under the company’s umbrella. Now, CareFusion has an exclusive worldwide distribution agreement with NOX for all the products that they may develop related to sleep. The first major product under the agreement is the NOX-T3 portable sleep monitor, and both sides are happy with the relationship.

“Our hope was that we would be able to take sleep diagnostics and break open the bottleneck,” says Wyscarver. “The bottleneck is that if you have a sleep disorder and, you go to or call a sleep lab, they will often say come back in 6 weeks for your sleep test. Imagine if you showed up to a hospital or clinic with a broken arm, and they said come back in 6 weeks.

“Most would be horrified at the prospect of dealing with a broken arm for 6 weeks. Such is the case with most sleep labs,” continues Wyscarver. “And yet with apnea, a severe medical condition, it is acceptable to tell someone who can’t stay awake—and falls asleep while driving—that he should come back in 6 weeks. It is completely unacceptable.”

Transcending the Feature War

Under the body area network (BAN) monitoring approach, the NOX-T3 features an array of wireless sensors, including a Bluetooth® receiver. The Bluetooth is similar to a USB, with one port that can accommodate multiple items. “We are going to be pairing with up to 7 wireless devices,” says Wyscarver. “So at the moment we are pairing with a Bluetooth oximeter and a CO2 monitor. In mid-year 2010, we’ll pair with an auto titrating CPAP unit. When you couple the advanced technology with the ease of use, you can break open the diagnostic bandwidth and catch up with these apnea sufferers.”

Seeking to avoid mere variations on the same theme, Wyscarver hopes to transcend what he calls the ongoing feature war that has been raging for the last decade. “The challenge with wireless is to avoid the trap of getting enamored with the technology without thinking about the clinical benefits,” enthuses Wyscarver. “It may be trendy to say that it is wireless, but what is the clinical yield? What is the cost benefit? You must have good answers to those questions before implementing wireless technology.”

One of the problems with home testing is having the patient run the oximeter wire up the arm and down the chest, as this is fairly difficult for the average patient. For the patient, it is one of the vulnerable spots during recording. The additional task of unplugging an analog output cable from a CO2 monitor is also something that patients should not be asked to do. Both these tasks are made considerably easier with NOXT3′ s wireless technology.

NOX-T3

Ultimately, it boils down to an expansion of use for the product. “The NOX-T3 is for the sleep diagnostic market, but we are planning on going into the recovery room environment,” reports Wyscarver. “Also transitioning from invasive to noninvasive ventilation—and there are some channels there that pulmonologists want to monitor over time. The NOX-T3 platform can move to those environments with relative ease.

Wyscarver candidly observes that the NOX-T3 has thus far garnered a tepid response from sleep labs. Just one in nine of all NOX-T3s sold go to sleep labs, but CareFusion does sell an AASM-compliant full sleep lab system. “It is my opinion that the sleep community—established, accredited labs in hospitals— have taken a pass on home sleep testing,” says Wyscarver. “They feel the clinical outcome is not good enough and think if you don’t attend, and don’t have an EEG, it can’t be a sleep study. They don’t see the validity.”

“They also feel threatened financially in that if they start doing home testing, their revenue will be reduced, because if you do a study at home you are taking a person out of the in-lab scenario,” continues Wyscarver. “If you look at who is buying the NOX-T3, it is a clinician with an overweight patient, and the patient has no comorbidities. Why can’t a physician with a NOX-T3 recorder diagnose that patient with the assistance of the accredited sleep lab and board certified physician? Our biggest customers are working with board certified sleep physicians, not sleep labs.”

While pulmonologists have rightly dominated the sleep market for a long time, CareFusion has sold about 800 NOXT3s to cardiologists, a crucial and growing market. These clinicians appreciate the ease of use and the cost, which is on the lower end of the price range. FDA-approved for patients as young as 2 years old, CareFusion officials hope the NOX-T3, and additional products from the engineering team at NOX Medical, will continue to make an impact.

As home sleep testing continues to evolve, evidence-based outcomes will become more important and more available. With that in mind, Wyscarver reports that the University of Alberta recently began an extensive longitudinal pediatric

study to evaluate the impact of sleep disorders on overall pediatric health. Researchers will attempt to associate sleep disorders with pediatric disorders. “It is the largest study of its kind,” he says, “and they are going to use the NOX-T3 for their principle data collection system.”

NOX-T3 Portable Sleep Monitor at a Glance

  • Wireless Bluetooth® Oximeter.
  • Miniaturized technology: 88gram/79×63×21mm (with battery).
  • Thorax & Abdomen RIP Effort + RIP Flow – RIP phase for paradoxical breathing.
  • Integrated snore microphone with true audio signal.
  • Gold Standard PSG Signals.
  • Check waveforms real time.
  • No accessible connectors/child safety battery door.
  • Full featured type 3 device/Type 4 size and complexity.
  • Flow signal through RIP Effort and/or nasal cannula.
  • Wireless signals: SpO2, Pulse, Snore, Body Position.
  • Off-the-shelf disposable or rechargeable batteries (AA).
  • Inclusive analysis and reporting software.
  • Extended applicability: pediatric, dental and ENT patients.
  • Extensive review possibilities.
  • Configurable data management.
  • Multi-night recordings.

For more information about the NOX-T3, visit www.carefusion.com.

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