Boston Scientific (NYSE:BSX) said yesterday that it won FDA approval for MR-conditional labeling on its Vercise Gevia deep-brain stimulation device for treating Parkinson’s disease.
The ImageReady MRI label means the device and its companion Vercise Cartesia directional lead can be used during 1.5-Tesla full-body MRI scans, the Marlborough, Mass.-based company said.
“Boston Scientific continually strives to deliver new solutions that advance the field of neuromodulation and most importantly, result in better outcomes for our patients around the world,” neuromodulation president Maulik Nanavaty said in prepared remarks.
“When evaluating which DBS system is best for each of my patients, I always consider the immediate and long-term needs my patient might have so that we can effectively address a patient’s therapeutic needs even as their disease progresses,” added Dr. Robert Gross of Atlanta’s Emory University. “Customizable therapy, battery life, the size of the device, and access to MRI are factors patients should talk to their doctor about when they are considering deep brain stimulation.”
