The trial enrolled obstructive sleep apnoea patients who were unable or not willing to use positive airway pressure treatment. Credit: Ground Picture / Shutterstock.com.

Medical technology company LivaNova has reported positive predictive outcomes from its OSPREY clinical study of the aura6000 hypoglossal nerve stimulator system for treating obstructive sleep apnoea (OSA).

Based on the latest data, the company announced the early conclusion of subject enrolment in the trial.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

The OSPREY study intended to treat obstructive sleep apnea by targeted hypoglossal nerve stimulation.

The prospective, multicentre, randomised, controlled, open-label trial evaluated the safety and effectiveness of the aura6000 system versus a no stimulation control in moderate to severe OSA patients.

It enrolled patients with OSA who were unable or not willing to use positive airway pressure treatment.

See Also:

Demonstrating a higher apnoea-hypopnea index (AHI) responder rate in subjects with device stimulation activated compared to subjects without stimulation after seven months of follow-up, is the trial’s primary efficacy endpoint.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Defined as a 50% improvement from baseline AHI and resulting in an AHI value below 20, the response rate is a critical measure for the study.

A planned interim analysis data indicated a greater than 97.5% chance of success in achieving the study’s primary goal.

LivaNova has informed the US Food and Drug Administration (FDA) and its partner study centres about this significant achievement.

Following the completion of the seven-month follow-up for the full cohort, the company plans to submit the final clinical module of the OSPREY study to the FDA.

The study also evaluates the safety of the aura6000 system and its impact on patient quality of life, with measures such as daytime sleepiness being assessed.

LivaNova CEO Vladimir Makatsaria said: “We are pleased to have achieved this positive milestone for the OSPREY study.

“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.”

Last year, the FDA granted 510(k) clearance to LivaNova’s Essenz heart-lung machine for use in cardiopulmonary bypass procedures.