ImThera of San Diego, CA received the CE Mark to bring its aura6000 system for treating obstructive sleep apnea (OSA) to Europe. The system includes an implantable neurostimulator with electrode leads going to the hypoglossal nerve that controls the movement of the tongue. Using a paired remote control, patients can turn the device on and off, as well as wirelessly recharge it as necessary.
The aura6000 acts like a pacemaker for the tongue, cycling through stimulating different muscles of the organ to open the upper airway during sleep.
Some details about the system from the product page:
- A multi-contact electrode specific to the Hypoglossal nerve. The electrode connects to the IPG via a lead wire.
- An implantable pulse generator (IPG) enclosure which contains the electronics and the RF receive-transmit antenna. It is externally programmable, specifically for each patient, and re-chargeable.
- Patient’s controller, charger and programmer device. The external controller interfaces to the IPG for patient functions and to the physician’s computer for set-up and programming.
- Physician’s PC including the aura6000 Clinical Manager software.
Press release: ImThera Medical Announces European CE Mark Approval for the aura6000 System to Treat Obstructive Sleep Apnea
Product page: aura6000 system
Flashback: ImThera’s Targeted Hypoglossal Neurostimulation Therapy for Obstructive Sleep Apnea