USFDA nod for ImageReady MRI labelling for DBS system

October 8, 2019 0 By FM

Boston Scientific Corporation said USFDA granted clearance for its ImageReady MRI labelling for the Vercise Gevia Deep Brain Stimulation (DBS) System to be used in a full-body magnetic resonance imaging (MRI) environment.

This system, 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.

Clinical evidence from the INTREPID study demonstrated that 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, which is favourable to the previous published report.

The system has also been commercially available in the European market since 2017.