Alpha Omega Receives Approval To Sell Its Real-Time DBS Navigation Platform (HaGuide) In Europe

NeuroOmega system has the capability to record and stimulate brain electrical activity, peripheral nerve and skeletal muscles through a total of 122 channels.  HaGuide is a real-time solution designed to accurately detect the Subthalamic Nucleus region and the location for ideal stimulation.

Alpha Omega has received a CE mark for its real-time DBS navigation platform (HaGuide) that runs on NeuroOmega, Alpha Omega’s microelectrode recording (MER) flagship system.

This newly powerful integration between the NeuroOmega and the HaGuide software represents a breakthrough for the deep brain stimulation (DBS) procedure.

HaGuide has the ability to automatically detect entry, exit and sub-regions of Subthalamic Nucleus (STN), including the Dorso-lateral Oscillatory Region (DLOR) sub-region (referred to as the motor part of STN), and Ventro Medial Non-Oscillatory Region (VMNR) (referred to as the non-motor part of STN). In addition, HaGuide recommends to the user the location for ideal stimulation.

HaGuide also adds an online support component, which serves as an additional source of information designed to provide the optimal therapeutic window. All combined, the HaGuide significantly shortens the time of DBS, which provides tremendous value to both neurosurgeons and patients.

“An estimated 15.2–34.0% of all DBS surgeries are for revisions or removals. Up to 48.5% of revisions may have been due to improper targeting or lack of therapeutic effect”

- Department of Neurological Surgery, University of California, San Francisco, United States*

 “Automatic systems overcome the bias of human operators and enable better STN targeting where electrophysiology interpretation of MER data is not available”

- Hagai Bergman MD-Ph.D. consultant electrophysiologist, Department of Medical Neurobiology The Hebrew University

HaGuide has already passed a multilayer validation process and validated in several centers around the world, including Hadassah Ein Kerem, Israel, Children's Hospital Colorado, and University Medical Center Hamburg-Eppendorf Germany.

“With the latest innovation in navigation assistance software, Alpha Omega continues its mission to make the DBS procedure as accessible, accurate and efficient as possible for all patients,” said Imad Younis, President of Alpha Omega. “HaGuide is a major step in achieving this goal.”

 

About Alpha Omega

Alpha Omega is a world-leading medical device company, specializing in neurosurgery and neuroscience. The company offers leading edge solutions for enhancing and simplifying Deep Brain Stimulation (DBS), by implementing sophisticated software and hardware for brain mapping and navigation. DBS is used to treat both neurological and psychiatric disorders.

John D.Rolston Dario - J.Englot Philip - A.Starr - Paul S.Larson

An unexpectedly high rate of revisions and removals in deep brain stimulation surgery: Analysis of multiple databases

ELSEVIER, 33(2016), pp. 72-77, www.sciencedirect.com/science/article/pii/S135380201630339X