Boston Scientific Receives FDA Approval for Image Guided Programming Software

The U.S. Food and Drug Administration has approved Boston Scientific Corporation’s latest image guided programming software, Vercise Neural Navigator with STIMVIEW XT.

Developed in collaboration with Brainlab AG, a software-driven medical technology company, STIMVIEW XT enables clinicians in real-time, the ability to visualize both lead placement and stimulation modeling of the brain anatomy of their patients living with Parkinson’s disease or essential tremor.
 
STIMVIEW XT, used with the Vercise Genus Deep Brain Stimulationⁱ (DBS) portfolio, is engineered to be the most advanced and integrated visualization software for DBS programming. The software enables patient-specific 3D visualization of the anatomy for clinicians to better personalize therapy to meet each patient’s needs. It seamlessly integrates into the Vercise Genus programming interface, designed to help localize lead placement, reduce programming time and enable more informed treatment decisions.
 
“It’s exciting that clinicians will now have access to more sophisticated image guided programming tools supporting personalized DBS therapy,” said Jill Ostrem, M.D., medical director, University of California San Francisco, Movement Disorders and Neuromodulation Center. “This advancement with STIMVIEW XT may also save time for the clinician as it could help avoid the trial and error in finding the precise location. Prolonged periods of time in adjusting stimulation settings can be stressful and tiring for patients.”
 
In a recent study, clinicians were able to adjust patient stimulation in an average of 20 minutesⁱⁱ with the Boston Scientific visualization software, lowering programming time by 56 percent.ⁱⁱⁱ 
 
“Every person’s experience living with Parkinson’s disease or essential tremor is unique, and their treatment should be as unique,” said Maulik Nanavaty, senior vice president, Neuromodulation, Boston Scientific. “Our technologies enable clinicians to precisely see, shape, and steer DBS therapy to meet their patients’ individual needs. This latest advancement is a testament to how we’ll continue to deliver on meaningful innovations that support doctors.”
 
The U.S. launch of Vercise Neural Navigator with STIMVIEW XT follows the European launch of the software providing broader access to clinicians who treat people living with Parkinson’s disease or essential tremor.
 
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) environment,1 consists of a family of Bluetooth-enabled, rechargeable and non-rechargeable, IPGs that power Cartesia Directional Leads, designed to provide optimal symptom relief.
 
References 
ⁱ 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.
ⁱⁱ Lange et al. Reduced programming time and strong symptom control even in chronic course through imaging-based DBS Programming. Frontiers in Neurology. 2021;12. doi:10.3389/fneur.2021.785529
ⁱⁱⁱ Compared with standard clinical based programming, p=0.039