ImThera Medical Inc reported results from its European study of the aura6000 neurostimulation device for the treatment of OSA at the American Thoracic Society (ATS) 2011 Conference. Safety and efficacy outcomes of the Phase I (3-month data) protocol are positive and included results of the protocol.
The study was completed at Université Catholic de Louvain, St. Luc Hospital, and was comprised of moderate to severe noncompliant CPAP patients. Ten patients have completed Phase I, with all patients demonstrating compliance to ImThera’s Targeted Hypoglossal Neurostimulation (THN Sleep Therapy).
Enrolled patients had a baseline diagnostic apnea hypopnea index (AHI) ranging from 26.4 to 80 and a baseline diagnostic oxygen desaturation index (ODI) ranging from 11.7 to 75.9. After 3 months of nightly use of THN therapy, subjects showed marked improvement:
• Mean AHI reduction from screening to week 12 of 24.7 ± 13.2 (50.2% improvement)
• Mean ODI reduction from screening to week 12 of 19.3 ± 15.8 (54.3% improvement)
• Mean HI reduction from screening to week 12 of 15.2 ± 13.2 (46.1% improvement)
• Mean ESS reduction from screening to week 12 of 5 ± 7.3 (50.5% improvement)
• In a pre-defined subgroup, 7 of 10 patients showed a mean AHI reduction of 68.0%, ODI reduction of 68.1%, and HI reduction of 64.1%
Additionally, quality of sleep as measured by arousal events across study visits showed a mean decrease from screening to week 12 of 94.6 ± 102.4 (64.9% improvement).
“We continue to see positive results and improvement in OSA patients who have failed CPAP when using the aura6000 device,” said Marcelo G. Lima, president and CEO of ImThera. “The company is preparing for the next phase as we look forward to CE mark in Europe and beginning our FDA clinical trial.”
The aura6000 is based on ImThera’s proprietary Targeted Hypoglossal Neurostimulation (THN Sleep Therapy), delivering stimulation to key muscles of the tongue during sleep. The device is not for sale in the United States.