Boston Scientific’s deep brain stimulation implant for treating the symptoms of Parkinson’s disease has been newly approved by the FDA as safe to use within an MRI.
The company’s Vercise Gevia pulse generator and its Vercise Cartesia directional lead had previously received the agency’s green light for improving motor function and were commercially launched in the U.S. in January.
The system is designed to deliver targeted electrical stimulation to specific regions of the brain to help control symptoms such as shaking or tremors as well as muscle stiffness and slowness of movement.
The latest approval allows implanted patients to undergo a full-body, 1.5 Tesla MRI scan, including while the device is being programmed by a neurologist.
A previous clinical study saw a 48% improvement in patient scores tracking movement and motor function with the rechargeable battery-powered device. The MRI-ready Vercise Gevia system has been CE marked and available in the European market since 2017.
Additionally, this week Boston Scientific closed its $4.2 billion cash deal to acquire the London-based devicemaker BTG along with its oncology and vascular franchises. First announced last November, Boston Scientific hopes the acquisition will transform its cancer business from one focused mainly on delivery tools into a $500 million interventional medicine portfolio.
"Leveraging the employee talent and clinical and commercial expertise of these two high-performing organizations will generate continued innovation and access so that we may advance patient care in ways that neither company could do alone," Boston Scientific Chairman and CEO Mike Mahoney said in a statement, with BTG becoming a wholly owned subsidiary.