Vercise™ Indications, Safety, and Warnings
The Vercise™ DBS System has CE Mark and is available for sale in Europe, Israel, Australia and select countries in Latin America for PD, and has CE Mark for intractable primary and secondary dystonia and tremor. The Vercise PC DBS System has CE Mark and is available for sale in Europe. In the U.S., the Vercise DBS System is investigational and not available for use or sale.
The Vercise™ and Vercise PC Deep Brain Stimulation (DBS) Systems are indicated for use in unilateral or bilateral stimulation of the subthalamic nucleus (STN) or internal globus pallidus (GPi) for treatment of levodopa-responsive Parkinson’s disease which is not adequately controlled with medication and also for treatment of intractable primary and secondary dystonia, for persons 7 years of age and older.
Thalamic stimulation using Boston Scientific’s DBS Systems is indicated for the suppression of tremor not adequately controlled by medications in patients diagnosed with Essential Tremor or Parkinson’s disease.
The Vercise M8 Adapter is a 1 x 8 in-line connector that is designed to connect specific Medtronic® lead extensions to the Boston Scientific DBS System Stimulator, as part of a deep brain stimulation procedure.
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CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Information is for the use only in countries with applicable health authority product registrations. Not for distribution in France.