LivaNova Announces a Positive Predictive Outcome of Trial Success in its OSPREY Clinical Study for Moderate to Severe Obstructive Sleep Apnea
20 Marzo 2024 - 7:00AM
Business Wire
LivaNova PLC (Nasdaq: LIVN), a market-leading medical technology
company, today announced its OSPREY clinical study, Treating
Obstructive Sleep Apnea Using Targeted Hypoglossal Nerve
Stimulation, has achieved a positive predictive outcome and will
conclude enrollment earlier than anticipated. This means there is a
greater than 97.5% probability that the OSPREY trial will
successfully meet its primary endpoint. OSPREY is a prospective,
multi-center, randomized controlled open-label trial demonstrating
the safety and effectiveness of the aura6000™ Hypoglossal Nerve
Stimulator System versus a no stimulation control in subjects with
moderate to severe obstructive sleep apnea (OSA) who have failed or
are unwilling to use positive airway pressure treatment. LivaNova
notified the U.S. Food and Drug Administration (FDA) and its
partner trial sites of this significant milestone for the OSPREY
study.
“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 California, San Diego and Principal Investigator
for OSPREY. “While this milestone shows we are on a positive
trajectory, long-term follow-up visits will continue for each
patient through the primary endpoint and beyond.”
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 50% improvement from the baseline AHI, leading to an AHI
value below 20. After the full cohort completes the seven-month
follow-up visit and the results are compiled, LivaNova will submit
OSPREY’s final clinical module to the FDA.
“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 75%
are undiagnosed. If left untreated, OSA can have serious
implications, including increased cardiovascular disease, stroke,
metabolic disease, excessive daytime sleepiness and a higher risk
for traffic accidents.
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 London, LivaNova employs
approximately 2,900 employees and has a presence in more than 100
countries for the benefit of patients, healthcare professionals and
healthcare systems worldwide. For more information, please visit
www.livanova.com.
Safe Harbor Statement
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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LivaNova Investor Relations and Media Contacts +1
281-895-2382 Briana Gotlin Director, Investor Relations
InvestorRelations@livanova.com Deanna Wilke VP, Corporate
Communications Corporate.Communications@livanova.com
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