Itamar Medical Clarifies ICSI Home OSA Testing Guidelines.

BOSTON -- With the intent to clarify the wording of the May 2004 Minnesota Institute for Clinical Systems Improvement (ICSI) Health Care Guideline: Diagnosis and Treatment of Obstructive Sleep Apnea, Itamar Medical is releasing the actual sections in the ICSI guideline document that refer to home testing for sleep apnea and to "a device that utilizes peripheral arterial tone with combined oximetry and actigraphy." These sections read as follows:

Algorithm Annotations section 7: "The accepted standard test for
    diagnosis of OSAHS is polysomnography, which is indicated for the
    diagnosis of all patients suspected of having this disorder. ...
    (S)ome physicians are interested in expanding the use of in-home,
    unattended, portable recording (devices). At present the evidence
    supporting this expansion is limited and at times conflicting, but
    employment of portable monitoring as a second-best option is not
    likely to result in harm to patients with a high pretest
    probability of OSAHS, and may result in less risk than leaving the
    condition undiagnosed. ... In a patient with suspected OSAHS, a
    negative study must be followed by a polysomnographic test."

    Discussion and References section 7: "An emerging technology for
    home portable monitoring (is) a device that utilizes peripheral
    arterial tonometry combined with oximetry and actigraphy (a
    movement measurement) ), is not classified as a cardiorespiratory
    monitor and was not considered in the (previous) systematic
    reviews.... There is an emerging literature to suggest this device
    may play a role in the diagnosis of OSAHS, and the committee felt
    that the device was at least equivalent to available
    cardiorespiratory monitors. As it is involves fewer sensors, it is
    simpler for most patients to apply in the home. ... Additional
    clinical studies are needed before the device is employed
    routinely in the diagnosis of OSAHS in place of polysomnography."

ICSI's complete Guideline is available on ICSI's Web site at: http://www.icsi.org/knowledge/detail.asp?catID=29&itemID=891

Itamar Medical is not connected in any way with the ICSI organization, nor has ICSI specifically referred to Itamar Medical, or approved Itamar's Watch PAT device by name, in its May 2004 guideline document. Itamar wishes to correct any misleading impressions or statements to the contrary made in a previous press release or advertisements.

For more information on Itamar Medical's Watch PAT device, which utilizes its proprietary peripheral arterial tone (PAT) technology, please visit www.itamar-medical.com, or call 1-888-748-2627.

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