Boston Scientific (NYSE:BSX) announced that it received CE Mark for its fourth-generation Vercise Genus deep brian stimulation system.
Vercise Genus includes full-body MRI conditional and Bluetooth capabilities within a DBS system designed for treating the symptoms of Parkinson’s disease, essential tremor and dystonia by delivering electrical stimulation to targeted parts of the brain.
Marlborough, Mass.-based Boston Scientific, which is rolling out the system in a limited European release as a result of regulatory approval, said in a news release that Vercise Genus adds features for patients such as a low-profile two-in-one extension with an option for abdominal placement, plus new software optimizes programming with imaging via an exclusive relationship with Brainlab.
European indication for the system includes use in unilateral or bilateral stimulation of the subthalamic nucleus or internal globus pallidus for treating levodopa-responsive PD that isn’t adequately controlled with medication, as well as for treating intractable primary and secondary Dystonia in persons seven years of age or older.
Thalamic stimulation using the Vercise Genus DBS system is indicated for suppressing tremor that isn’t adequately controlled by medications in patients who have essential tremor or PD. All indications are in Europe, as the system is not yet available for use or sale in the U.S.
“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,” Boston Scientific senior VP & president of neuromodulation Maulik Nanavaty said in the release. “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.”
