When testing the aura6000 implant, LivaNova didn’t exclude patients who have historically been seen as poor candidates.
By Sree Roy
Unlike the US pivotal trials conducted by Inspire Medical Systems Inc and Nyxoah SA, the OSPREY pivotal trial by LivaNova PLC deliberately did not exclude obstructive sleep apnea (OSA) patients with complete concentric collapse, a challenging subset who have historically been seen as poor candidates for neurostimulators.
Complete concentric collapse at the soft palate, also known as CCC (pronounced “triple-C”) and defined by circumferential palatal obstruction, is a contraindication for the use of Inspire and was not included in the DREAM pivotal trial submitted to the US Food and Drug Administration (FDA) for the newly approved Nyxoah Genio neurostimulator. Nyxoah could potentially add the indication depending on the results of its ongoing ACCCESS study.
No DISE Screening
LivaNova’s aura6000 System remains investigational only in the United States while its FDA review is ongoing, but much can be gleaned from its OSPREY pivotal clinical trial data.
A significant difference in LivaNova’s pivotal trial design was its approach to CCC, a condition affecting approximately 20% to 30% of OSA patients.
“Despite including the most severe patient population and not excluding the patient group that is most difficult to treat, CCC, we had very strong responder rates and we had very rapid onset,” says Ahmet Tezel, PhD, chief innovation officer at LivaNova. “That makes us very proud of our clinical trials.”
The current pathway for Inspire therapy requires drug-induced sleep endoscopy (DISE) to screen out CCC patients. This adds a separate procedure to the treatment pathway—one that typically adds several weeks and results in some patients who don’t qualify for the implant.
LivaNova took a different approach: the company didn’t perform DISE screening and didn’t exclude CCC patients from its trial.
While the OSPREY trial didn’t directly identify which patients had CCC, analysis using a predictor algorithm (based on factors such as neck circumference) suggested that approximately 30% of trial participants were at high risk for CCC. Notably, these patients showed comparable clinical outcomes to the broader trial population, according to Tezel.
Randomized Controlled Trial with Sham Arm
LivaNova’s OSPREY study was a randomized controlled trial (RCT) with a sham control arm. Though implanted at the same time as the treatment arm, patients in the control arm went six months without stimulation therapy (before having their devices turned on after the six-month data was collected).
According to Tezel, the enrolled population aligned closely with real-world OSA demographics across three key parameters: BMI, apnea-hypopnea index (AHI), and oxygen desaturation index (ODI).
“We’re very excited that we were able to provide level-one critical evidence with an RCT, the first and only. We’re very proud that we were able to enroll the most severe patient population that represents the American population,” Tezel says.
Response rates were notable: 25% of patients showed improvement on day one, increasing to 50% responders by day 90. At 12 months of therapy, the treatment arm responder rate was 65%. (Responders are defined as those who realized at least a 50% improvement from the baseline AHI and an AHI value below 20.)
Proximal Versus Distal Nerve Stimulation
LivaNova attributes these results to its proximal hypoglossal nerve stimulation approach. In other words, the company places electrodes at the proximal end of the nerve before it branches, allowing stimulation of a broader range of tongue muscles. By contrast, Inspire’s electrodes are positioned more distally, after the nerve has begun to segment.
“We believe that the ability to impact broader muscle groups gives our technology more flexibility,” Tezel says.
Implant Procedure
The surgical procedure shares similarities with Inspire implantation. Both systems use an implantable pulse generator placed in the chest connected to an electrode cuff around the hypoglossal nerve. The key difference is the anatomical target: LivaNova accesses the nerve trunk proximally, before branching, while Inspire requires dissection further along the nerve to reach the specific distal branches.
In its trials, LivaNova reported an average procedural time of 72 minutes. With Inspire V (its latest generation), Inspire shortened its implant time by eliminating the separate sensing lead. Inspire states that the implantation is now a 60-minute outpatient procedure.
LivaNova Implant Regulatory Status
The aura6000 had CE mark approval in Europe, but LivaNova opted not to maintain it and the device has never been actively marketed there. LivaNova submitted a modular premarket approval (PMA) to the FDA, with the final clinical module submitted before its May 7 earnings call. (Standard PMA review timelines run 9 to 12 months.)
Clinical Implications
For sleep physicians, the potential approval of aura6000 could streamline the upper airway stimulation pathway by eliminating the DISE step and expanding the eligible patient population. Whether this translates to broader real-world adoption will depend on how the FDA incorporates these trial findings into any approved labeling.
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