StimGuide by Magstim: The First Clinical TMS Navigation System to Receive 510K Clearance

EDEN PRAIRIE, Minnesota, May 16, 2019 /PRNewswire/ -- Magstim^®TMS has launched the very first Transcranial Magnetic Stimulation navigation system specifically developed for the clinical market.

StimGuide^®, which has received FDA 510K clearance, is a unique navigation system used with Magstim's Horizon^® Performance TMS Therapy System. It provides precise and consistent coil positioning in the treatment of Major Depressive Disorder.

The 3D navigation system aligns four distinct parameters to guide clinicians to a precise target area for treatment, reducing any potential variability in treatment and improving confidence and consistency in the delivery of the TMS therapy.   

Dr Mark George, MD from Medical University of South Carolina, said: "I am thrilled that this technology is now available. As the TMS research field continues to advance towards treating targets tailored for each patient, a tool like StimGuide^® provides a solution for simple, repeatable, and precise coil positioning."

StimGuide was developed to provide a solution for the majority of clinical centers that do not have access or the resources to provide pre-treatment MRIs for patients. It offers the benefits of 3D navigation  without the expense and complexity associated with more complicated navigation technology.

With this new solution, clinicians do not have to choose between a one-dimensional contact sensor or a more complex research-based navigation option. With StimGuide^®, they have a solution that leapfrogs a cap and measuring method or contact sensor technology and provides the benefits of precise and repeatable coil positioning.

As the TMS field continues to grow and evolve in the treatment of Major Depressive Disorder, there is an increasing need for a tool that provides a quality control tool that reduces treatment variability among technicians and within a treatment session.

"I am convinced that StimGuide^® will improve patient care because it ensures reliable placement over the intended treatment target providing confidence to experienced and new TMS treaters.  StimGuide^® accurately measures the distance of the coil from the intended target as well as rotation and pitch ensuring every pulse train is delivered in the optimal coil position," said Lothar Krinke, Group CEO, Magstim^®

Several centers across the US are already using the StimGuide^® technology as part of a Magstim-sponsored clinical study which measures the quality of TMS pulses delivered during a treatment session. The CONFIDENT study aims to quantify the percentage of pulses that are delivered within four distinct parameters used for positioning.

Dr Roger Pottanat, MD from Weymouth, MA, represents one of the sites in the CONFIDENT study. He said, "StimGuide improves our confidence that we are treating the right location regardless of changes in patient positioning."

StimGuide^® operates with Magstim's Horizon^® Performance System which recently received 510K for the iTBS 3-minute protocol (theta burst). The combined solution features the proprietary Energy Recovery System (ERS) that ensures consistent treatment throughout a session with no pulse decay. The versatile E-z Cool Coil has a longer pulse width that is optimized for patient comfort and has been shown to be more tolerable for patients.

Magstim pioneered TMS therapy 30 years ago and it is now widely used to treat Major Depressive Disorder across Europe, the US and the rest of the world.

Please direct media enquiries to Jo Wallace at Yogi on +44 (0) 2920 460 234 or [email protected].

SOURCE Magstim