MARLBOROUGH, Mass., September 10, 2020 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) announced it has received CE Mark and initiated a limited market release of the fourth generation Vercise Genus™ Deep Brain Stimulation (DBS) System in Europe. Featuring full-body MRI conditionaland Bluetooth capabilities across the portfolio, the Vercise Genus System is indicated to treat the symptoms of Parkinson’s disease (PD), essential tremor, and dystonia by delivering precisely targeted electrical stimulation in the brain designed to provide optimal symptom relief.
“With neurodegenerative movement disorders, the ability to deliver the right dose of stimulation where it is needed can make a remarkable difference in controlling an individual patient’s symptoms,” says Veerle Visser-Vandewalle, M.D., Ph.D., Cologne University Hospital, Germany.
Vercise Genus adds features for patients, including a low-profile two-in-one extension with the option of abdominal placement. New clinician software optimizes programming with integrated visualization using patient imaging via the company’s exclusive relationship with Brainlab.
“Advanced directional stimulation combined with a visualization system based on a patient’s own brain anatomy now provides the accurate navigation as well as the steering capability we need to optimize therapy outcomes,” said Jens Volkmann, M.D., Ph.D., director and chairman, Department of Neurology at the University Hospital of Würzburg, Germany.
The fourth generation DBS system since 2012, Vercise Genus builds upon rapid, meaningful innovations such as multiple independent current control (MICC) and the Cartesia™ Directional Lead with integrated visualization. “For patients, the Vercise Genus DBS System continues the tradition of small, thin devices, and it provides Bluetooth programming which is important during times of social distancing,” said Maulik Nanavaty, senior vice president and president, Neuromodulation, Boston Scientific. “Combined with the option of a 25-year rechargeable battery as well as the expanded MRI conditional1 feature available on our primary cell devices, patients can find the best option to suit their specific needs.”
More than 10 million people worldwide are living with PD – a progressive, neurodegenerative disorder which causes stiffness, slowness and tremors due to the decrease of dopamine in the brain. Dystonia is the third most common movement disorder after essential tremor and PD, affecting more than half a million men, women, and children across Europe.
In Europe, the Vercise Genus DBS System is indicated for use in unilateral or bilateral stimulation of the subthalamic nucleus or internal globus pallidus for treatment of levodopa-responsive PD which is not adequately controlled with medication and for treatment of intractable primary and secondary Dystonia, for persons 7 years of age and older. Thalamic stimulation using the Vercise Genus DBS System is indicated for the suppression of tremor not adequately controlled by medications in patients diagnosed with essential tremor or PD.
The Vercise Genus DBS System is not available for use or sale in the United States.
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1. Pavese et al. Traditional trial-and-error versus neuroanatomical-3D-image software-assisted deep brain stimulation programming in patients with Parkinson's disease, 2017 WSSFN Conference, Berlin. 2. 1.5 Tesla MRI conditional when all conditions of use are met. * The Vercise™ Gevia™ DBS System is not available for use or sale in the U.S. ** Vercise Cartesia™ Directional Lead and GUIDE XT - Caution: Investigational Device. Limited by Federal (or U.S.) law to investigational use only. Not available for sale in the U.S.