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Itamar Medical Receives FDA Clearance for its Wrist Mounted Ambulatory System to Diagnose Sleep Rela

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Itamar Medical Receives FDA Clearance for its Wrist Mounted Ambulatory System to Diagnose Sleep Rela

Written by Scott English
Tuesday, 12 August 2008
Watch-PAT200, one of the world’s smallest sleep monitoring devices, provides comfort, ease-of-use high-level sleep clinical data and diagnostics allowing the monitoring of sleep patterns in the comfort of the patient’s own bed with sleep center level results. Caesarea, Israel — August 12, 2008 - Itamar Medical, an international medical technology company developing non-invasive diagnostic systems using the Peripheral Arterial Tone (PAT™) signal, announced today that it has received FDA clearance for the most recent version of its Watch-PAT line of products, the Watch-PAT200. The Watch-PAT200 is designed to offer sleep specialists and other physicians managing sleep related breathing disorders with the optimal technology to diagnose and evaluate patients with Sleep Related Breathing Disorders. The Watch-PAT200 is the only diagnostic system that provides extensive, detailed and accurate sleep clinical data without requiring the attachment of multiple electrodes and sensors to the head, abdomen and torso, dozens of which are typically required for a study in the sleep lab. In addition to offering unparalleled comfort levels while undergoing a sleep study, patients can use the Watch-PAT200 in the privacy and comfort of their own home and bed. The Watch-PAT200 is one of the smallest ambulatory sleep diagnostic tools on the market, enabling a patient to comfortably and naturally sleep while information is being gathered by a small unit attached to the wrist which connects to a probe on the finger. The Watch-PAT200 system records all the necessary physiologic parameters from the fingers to provide physicians with a comprehensive sleep report with all the clinical information required to confirm or rule-out obstructive sleep apnea, including iApnea-Hypopnea Index (AHI), Respiratory Disturbance Index (RDI), Oxygen Desaturation Index (ODI), heart rate, snoring intensity, body position, identification of wake and sleep periods and detection of REM sleep stage. Israel Schreiber, President & CEO of Itamar Medical, has noted: “Sleep disorders have profound effects on the quality of life and increased risks of cardiovascular events, stroke and other morbidities in millions of people. The Watch-PAT 200 offers one of the most effective diagnostic and management tools for patients, who can now be diagnosed in virtually any setting, and obtain clinically verifiable information including accurate quantification of all primary sleep parameters. The Watch-PAT200 has been validated in a large body of evidence, including close to 40 peer-reviewed publications and over a hundred abstracts in leading scientific meetings, confirming the efficacy of this innovative technology." Gary Sagiv, Vice President for Itamar Medical for the United States has noted that: "our Watch-PAT has already been adopted by hundreds of providers around the US, including hospitals and independent sleep laboratories, physician practices and major healthcare networks like Kaiser Permanente and the Veterans Hospitals (VA system). Following the recent decision by CMS (Medicare) to cover CPAP therapy following a sleep study conducted at home, more providers are adopting the Watch-PAT. With the new capabilities of the device, diagnosing clinicians and referring physicians will receive information closely resembling the information provided following a sleep study in the laboratory." Itamar Medical (TASE: ITMR) is a medical technology company developing noninvasive diagnostic systems using Peripheral Arterial Tone (PAT™) signal, including the Watch-PAT™ systems for the diagnosis of sleep related breathing disorders and the Endo-PAT™ systems for assessment of endothelial function, a condition recognized as an early stage of cardiovascular and cerebrovascular diseases. For further information see http://www.itamar-medical.com. Bookmark with: Delicious Digg reddit Facebook StumbleUpon What are these?

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