MARLBOROUGH, Mass., Jul. 11, 2023 -- Boston Scientific Corporation (NYSE: BSX) today announced it has received U.S. Food and Drug Administration (FDA) approval for the Vercise™ Neural Navigator 5 Software, which when used as part of the Vercise Genus™ Deep Brain Stimulation (DBS) Systems, can provide clinicians with simple and actionable data for efficient programming in the treatment of people living with Parkinson’s disease or essential tremor.
“The ability to see the precise placement of DBS Systems enables us to target therapy to meet individual needs,” Mustafa Saad Siddiqui, M.D., professor of Neurology and Neurosurgery at Wake Forest School of Medicine and medical director of the DBS program at Atrium Health Wake Forest Baptist. “The new features in the Vercise Neural Navigator 5 are expected to help further reduce the time needed to adjust stimulation and minimize potential side effects, allowing us to optimize treatment benefits for each patient.”
The Vercise Neural Navigator 5 Software, with STIMVIEW™ XT Technology, is the latest addition to the fully integrated portfolio of image guided programming solutions for Boston Scientific DBS Systems. Developed in collaboration with Brainlab AG, a leading software-driven medical technology company, these tools have demonstrated a reduction in programming time by 56%1 and provide real-time visualization and stimulation of each person’s unique brain anatomy.
The Vercise Neural Navigator 5 Software includes an enhanced user interface that displays patient data in a simplified format and gives clinicians access to advanced settings for increased therapy delivery. The software is designed to enable more flexibility to better manage the evolving needs of individual patients at any stage of their condition.
"Developing meaningful tools to help physicians provide personalized treatments for their patients delivers on our promise to advance our technologies for people living with neurological conditions,” said Jim Cassidy, president, Neuromodulation, Boston Scientific. “Providing effective DBS therapy is complex and can be time-consuming. This software will help streamline the process and allow for more doctor-patient interaction time."
For more information about the Vercise Genus DBS Systems and image guided programming software, please visit STIMVIEWXT.com.
About the Boston Scientific DBS System
The fourth-generation Vercise Genus™ Deep Brain Stimulation (DBS) System is designed to treat the symptoms of Parkinson’s disease and essential tremor by delivering targeted electrical stimulation via surgically-implanted leads in the brain connected to an implantable pulse generators (IPG). The portfolio, approved for conditional use in a magnetic resonance imaging (MRI) environment2, consists of a family of Bluetooth-enabled, rechargeable and non-rechargeable, IPGs that power the Vercise Cartesia™ Directional Leads, designed to provide optimal symptom relief.
About Boston Scientific
Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 40 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. For more information, visit www.bostonscientific.com and connect on Twitter and Facebook.
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References:
- Lange, F et al. Reduced Programming Time and Strong Symptom Control Even in Chronic Course Through Imaging-Based DBS Programming, Front Neurol 2021 Nov 8;12:785529
- The Vercise Genus™ DBS System provides safe access to full-body 1.5T MRI scans when used with specific components and the patient is exposed to the MRI environment under specific conditions defined in the supplemental manual ImageReady™ MRI Guidelines for Boston Scientific DBS Systems.