LivaNova Announces a Positive Predictive Outcome of Trial Success in its OSPREY Clinical Study for Moderate to Severe Obstructive Sleep Apnea
“A planned interim analysis, per the approved protocol, was conducted for the first 90 patients enrolled in OSPREY. We are now able to estimate a high chance of success for achieving the primary endpoint in this unique randomized controlled trial without further patient enrollment,” said Dr. Atul Malhotra, Professor of Medicine at University of
The OSPREY study’s primary efficacy endpoint is the demonstration that the apnea-hypopnea index (AHI) responder rate of subjects with device stimulation activated is statistically significantly higher than the rate of subjects without stimulation after seven months of follow-up. For OSPREY, response is defined as at least a
“We are pleased to have achieved this positive milestone for the OSPREY study,” said Vladimir Makatsaria, Chief Executive Officer of LivaNova. “In accordance with the study protocol, once the last patient implanted completes their final follow-up visit, we will conduct the final analysis for the study. Until then, we will continue to actively work with the clinical sites to manage the study patients.”
The OSPREY study also assesses the safety of the aura6000 System and measures patient quality of life through indicators such as daytime sleepiness. For more information on the therapy and the treatment of OSA, visit the LivaNova website.
About Obstructive Sleep Apnea
OSA affects almost one billion people worldwide, of which
About LivaNova
LivaNova PLC is a global medical technology company built on nearly five decades of experience and a relentless commitment to provide hope for patients and their families through medical technologies, delivering life-changing improvements for both the Head and Heart. Headquartered in
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This news release contains “forward-looking statements” concerning the Company’s goals, beliefs, expectations, strategies, objectives, plans, underlying assumptions, and other statements that are not necessarily based on historical facts. These statements include, but are not limited to, statements regarding progress relating to the OSPREY study and the aura6000 system. Actual events may differ materially from those indicated in forward-looking statements as a result of various factors, including those factors set forth in Item 1A of the Company’s most recent Annual Report on Form 10-K, as supplemented by any risk factors contained in Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. LivaNova undertakes no obligation to update the information contained in this press release to reflect subsequently occurring events or circumstances.
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Source: LivaNova PLC