European Study of OSA Neurostimulation Device Complete
Results presented at ATS conference; could device impact sleep market?
- By David Kopf
- Jun 02, 2011
ImThera Medical, Inc. recently released the results from its European study of the aura6000 neurostimulation device for the treatment of Obstructive Sleep Apnea at the American Thoracic Society (ATS) 2011 Conference. Safety and efficacy outcomes of the Phase I (three-month data) protocol were positive, according to the company.
The study was completed at Université Catholic de Louvain, St. Luc Hospital and was comprised of moderate to severe non-compliant CPAP patients. Ten patients have completed Phase I, with all patients demonstrating compliance to ImThera’s Targeted Hypoglossal Neurostimulation (THN Sleep Therapy), the company reports.
Enrolled patients had a baseline diagnostic Apnea Hypoponea Index (AHI) ranging from 26.4 to 80 and a baseline diagnostic Oxygen Desaturation Index (ODI) ranging from 11.7 to 75.9. After three months of nightly use of THN therapy, subjects showed marked improvement:
- AHI Reduction from Screening to Week 12 of 24.7 ± 13.2 (50.2 percent Improvement)
- ODI Reduction from Screening to Week 12 of 19.3 ± 15.8 (54.3 percent Improvement)
- HI Reduction from Screening to Week 12 of 15.2 ± 13.2 (46.1 percent improvement)
- ESS Reduction from Screening to Week 12 of 5 ± 7.3 (50.5 percent Improvement)
- A pre-defined subgroup of seven of 10 patients showed a mean AHI reduction of 68.0 percent, ODI reduction of 68.1 percent, and HI reduction of 64.1 percent
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 percent improvement).
“We continue to see positive results and improvement in OSA patients who have failed CPAP when using the aura6000 device,” said Marcelo 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, not for sale in the United States, is based on ImThera’s proprietary Targeted Hypoglossal Neurostimulation (THN Sleep Therapy™), delivering stimulation to key muscles of the tongue during sleep.
The aura6000 system takes, on average, ninety minutes to implant surgically. The small, rechargeable stimulator does not require additional sensors to function.
David Kopf is the Editor of HME Business.