Vercise Genus Deep Brain Stimulation for Parkinson’s FDA Approved

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Boston Scientific has landed FDA clearance for its Vercise Genus Deep Brain Stimulation (DBS) System. This is the fourth generation of the company’s DBS devices, which are designed to have a longer battery life, improved targeting to reduce symptoms, and make programming and management easier.

Vercise Genus devices are available in rechargeable and non-rechargeable varieties, and are all safe for conditional use inside MRI scanners, given certain precautions. The implants rely on Boston Scientific’s Cartesia directional leads to deliver electric pulses to the brain. The company partnered with Brainlab to give physicians powerful visualization capabilities when implanting the leads to achieve optimal targeting of the subthalamic nucleus or globus pallidus. Bluetooth connectivity provides a wireless link to program the pulse generators and change their settings once they’re implanted.

“We have used the Vercise Gevia System with the Cartesia Directional Leads to provide our patients with a small device, a battery life of at least 15 years and optimal symptom control by delivering the right dose of stimulation precisely where it’s needed,” said Jill Ostrem, medical director and division chief, University of California, San Francisco Movement Disorders and Neuromodulation Center, in the announcement. “Now, the latest generation Genus portfolio – with an MR-compatible non-rechargeable IPG as well – provides greater access to patients who might not be candidates for a rechargeable system.”

According to Boston Scientific, the specific indications for the Vercise Genus are “for use in the bilateral stimulation of the subthalamic nucleus (STN) as an adjunctive therapy in reducing some of the symptoms of moderate to advanced levodopa-responsive PD that are not adequately controlled with medication. The system is also indicated for use in the bilateral stimulation of the internal globus pallidus (GPi) as an adjunctive therapy in reducing some of the symptoms of advanced levodopa–responsive PD that are not adequately controlled with medication.”

“We continue to prioritize therapy innovations that improve our patients’ quality of life with a wide range of personalized offerings,” said Maulik Nanavaty, senior vice president and president, Neuromodulation, Boston Scientific. “For people living with movement disorders, this means developing new technologies that are designed to refine motor control, reduce programming times and expand MR compatibility to improve their treatment experience and ultimately their daily living.”

Product page: Vercise Genus DBS System

Flashbacks: Boston Scientific’s Vercise Neurostimulation System Approved for Parkinson’s in U.S.; Boston Sci’s Vercise Gevia Deep Brain Stimulators for Parkinson’s Now Available in U.S.; Vercise Gevia Deep Brain Stimulation System with Visual Brain Targeting Software Cleared in Europe; Boston Scientific’s Vercise Deep Brain Stimulator Gets Expanded Indication in Europe for Dystonia; Vercise Deep Brain Neurostimulator EU Approved for Tremor

Via: Boston Scientific





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