Itamar Medical Announces Results from Multi-Center Study Validate Use of WatchPAT™ in Diagnosing Sleep Apnea in Patients with AFib
Results Further Support Use of WatchPAT for Home-Based Sleep Apnea Testing as an Effective Alternative to In-Lab PSG Testing
CAESAREA, Israel, Dec. 08, 2020 (GLOBE NEWSWIRE) -- Itamar Medical Ltd. (NASDAQ and TASE: ITMR), a leading medical device and digital health company leading the integration of sleep apnea management into the cardiac patient care pathway, today announced the publication of a new study titled, ‘Watch-PAT is Useful in the Diagnosis of Sleep Apnea in Patients with Atrial Fibrillation’, in the December 2020 edition of Nature and Science of Sleep validating the use of WatchPAT™ against gold standard in-lab polysomnogram (PSG) in the diagnosis of sleep apnea in patients with atrial fibrillation (AF).
The study, which included centers in the U.S., Canada, Germany and Israel, recruited 101 patients who were previously diagnosed with AF (persistent or paroxysmal) and suspected to have sleep apnea. The study concluded that WatchPAT, based on PAT™ technology (which measures and records the peripheral arterial tone) can diagnose sleep apnea events in patients with AF with and without nocturnal active AF episodes with accuracy similar to what was previously reported for general population, and with significant correlation to PSG testing outcomes.
“Since arrhythmias in general and AF in particular are quite common in patients with Obstructive Sleep Apnea (OSA), understanding the accuracy of WatchPAT in detecting sleep apnea in these patients is of substantial importance,” said Giora Pillar, MD, PhD, head sleep clinic network in the Haifa district of Clalit Medical Services. “The accepted gold standard for sleep apnea diagnosis is PSG; however, access to PSG is limited. The availability of Home Sleep Apnea Testing (HSAT) has provided a safe and convenient alternative, especially during the recent COVID19 epidemic when many sleep labs were closed.”
“The rising burden of AF has elevated the need for strategies aiming to lower its risk of development and progression. Sleep apnea has been recognized as one of the important modifiable risk factors for AF with evidence (level IIb) suggesting that effective management of sleep apnea improves AF. Because many AF patients do not present with typical SA symptoms, traditional screening questions and so called “eye-balling” was proven to have low sensitivity to sleep apnea in this population,” said Gilad Glick, CEO of Itamar Medical. “Encouragingly, many international professional societies, including ESC and AHA recommend screening and management of patients with AF for sleep apnea. The addition of the WatchPAT, based on PAT technology as an alternative home-based sleep test has the potential to meaningfully increase diagnoses and to improve the management of these patients.”
WatchPAT is a viable alternative to PSG for confirmation of clinically suspected sleep apnea that is based on peripheral arterial tone signal’s amplitude and rate, oxygen saturation and actigraphy. It provides accurate sleep/wake and REM/NREM discrimination together with non-REM categorization into deep and light sleep, as well as accurate measurements of snoring and body position and has recently been shown to be able to distinct obstructive from central sleep apnea.
The link between sleep apnea and cardiovascular disease (CVD) has been well-studied, showing a comorbid prevalence of 50% or higher. Sleep apnea, which is a serious and potentially life threatening respiratory sleep disorder, is estimated to affect approximately 54 - 60 million people in the U.S. of which most are believed to also suffer from a cardiovascular condition. Further research shows that roughly 80-85% of sleep apnea patients go undiagnosed and untreated and it is possible that the number of CVD patients who suffer from sleep apnea and go undiagnosed is similar.
About Itamar Medical Ltd.
Itamar Medical is a medical technology company focused on the development and commercialization of non-invasive medical devices and solutions to aid in the diagnosis of respiratory sleep disorders. Itamar Medical commercializes a digital healthcare platform to facilitate the continuum of care for effective sleep apnea management with a focus on the core sleep, cardiology and direct to consumer markets. Itamar Medical offers a Total Sleep Solution to help physicians provide comprehensive sleep apnea management in a variety of clinical environments to optimize patient care and reduce healthcare system costs. The Company’s key product, WatchPAT, is commercially available within major markets including the US, Japan, and Europe. Itamar Medical is a public company traded on the Nasdaq and on the Tel Aviv Stock Exchanges, and is based in Caesarea, Israel with U.S. headquarters based in Atlanta, GA. For additional information visit www.itamar-medical.com
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other applicable securities laws. Statements preceded by, followed by, or that otherwise include the words "believes", "expects", "anticipates", "intends", "estimates", "plans", and similar expressions or future or conditional verbs such as "will", "should", "would", "may" and "could" are generally forward-looking in nature and not historical facts. For example, when we discuss the addition of the WatchPAT, as an alternative sleep testing at home and its potential to increase diagnoses of patients, we are using forward-looking statements. Because such statements deal with future events, they are subject to various risks, uncertainties and assumptions, including events and circumstances out of Itamar Medical's control and actual results, expressed or implied by such forward-looking statements, could differ materially from Itamar Medical's current expectations. Factors that could cause or contribute to such differences include, but are not limited to, risks, uncertainties and assumptions discussed from time to time by us in reports filed with, or furnished to, the U.S. Securities and Exchange Commission (“SEC”) and the Israel Securities Authority (“ISA”), including our latest Annual Report on Form 20-F which is on file with the SEC and the ISA. Except as otherwise required by law, we undertake no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
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