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FDA Approved
AGC Biomedical Devices, Inc. has received FDA clearance for the ApLab, a screening device for detecting Obstructive Sleep Apnea Syndrome (OSAS). The ApLab was developed to provide physicians with a reliable, accurate screening tool that identifies sleep apnea. Our unit provides a complete and detailed breath-by-breath recording during sleep. Physicians can review the breathing data to confirm the number of obstructions, their duration and frequencies, and other respiratory events such as normal breathing, upper airway resistance and respiratory related arousals. From this information, the physician can determine the best course of treatment for the patient.
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The Impact of Sleep Disorders
OSAS has been linked to many serious health problems such as obesity, cardiovascular disease and hypertension. The common practice is to test for and treat these events while paying little attention to the possibility that sleep apnea may be the cause. This results in a lower level of patient wellness and disease management. With an accurate screening test, physicians can begin to identify and address what could be the root problem of these various conditions.
Diagnosing Sleep Disorders
The Clinical Practice Review Board of the American Academy of Sleep Medicine is a source of information for the cost justification in the diagnosis and treatment of sleep apnea. In one two-year study of 97 untreated sleep apnea patients, hospitalization days were increased 2.8 fold and physician cost doubled. Other studies show the medical costs for 238 undiagnosed sleep apnea patients were nearly double the cost of age and gender matched control subjects. Screening with the ApLab is a cost effective starting point in the process of diagnosing sleep disorders.
ApLab Technology
ApLab technology enables physicians to analyze patient information quicker and with more accuracy than ever before. ApLab uses pressure transducer technology to detect and record eight hours of respiratory data for physician review. The patient can mail the unit to AGC Biomedical Devices, Inc., return it to the prescribing physician or return it to a sleep clinic. The data is downloaded into the AGC Medical ApLab Viewer Program through a USB 2.0 connector plugged into the device. This software displays and prints actual respiratory data, as well as a compact review of the entire night to facilitate rapid interpretation. The data can be auto-scored by software or manually analyzed. The data provides an extremely accurate visual display of the pressure waveform on a breath-by-breath basis. A custom Windows application provides the tools to graphically display the data. Printed or electronic reports can also be produced.
Clinical studies have shown that Nasal Cannula Pressure (NCP) transducer technology, as used in the ApLab, is superior to thermistors and other commonly used respiratory monitoring devices.
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