Boston Scientific Nets FDA Approval for Image-Guided DBS Programming Software

Boston Scientific Corporation has received US 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, MD, 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, these tools demonstrate a reduction in programming time by 56% according to Lange et al., 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."