Medical company Boston Scientific Corporation (NYSE:BSX) reported on Monday the receipt of approval from the US Food and Drug Administration (FDA) for its ImageReady MRI labeling for the Vercise Gevia Deep Brain Stimulation (DBS) System for a full-body magnetic resonance imaging (MRI) environment to treat the symptoms of Parkinson's Disease (PD).
An estimated ten million people worldwide are affected by Parkinson's disease, causing symptoms of shaking or tremors, muscle stiffness, and slowness of movement.
The company added that the Vercise Gevia Deep Brain Stimulation system, along with the Vercise Cartesia Directional Lead, is designed to treat the symptoms of Parkinson's Disease (PD) by delivering precisely targeted electrical stimulation in the brain to provide optimal symptom relief and better control of unwanted side effects.
Following the US FDA approval, the patients can undergo a full-body MRI while benefiting from the latest advances in DBS therapy including directional stimulation and a longer-lasting rechargeable battery. The DBS therapy helps patients with Parkinson's disease control their symptoms and improve their quality of life.
Based on the clinical evidence from the company's INTREPID study, the patients treated with the Vercise System sustained a 48% improvement in motor function as measured by the Unified Parkinson's Disease Rating Scale (UPDRS) III scores over two years.
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