This is a brief overview of information related to FDA’s approval to market this product for patients who are diagnosed with essential tremor or parkinsonian tremor not adequately controlled by medications and where the tremor constitutes a significant functional disability. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name:    Vercise™ PC, Vercise Gevia™ and Vercise Genus™ Deep Brain Stimulation (DBS) Systems
PMA Applicant:    Boston Scientific Corporation
Address:        25155 Rye Canyon Loop, Valencia, CA 91355
Approval Date:    October 20, 2021
Approval Letter:    Approval Order

What is it?  

The Vercise™ PC, Vercise Gevia™ and Vercise Genus™ DBS Systems are implantable devices that deliver low-intensity electrical pulses to nerve centers in the brain using different combinations of amplitude (intensity), pulse width (time between start and stop of pulse), and frequency (number of pulses over time). These DBS systems consist of the following components: 

• An implantable pulse generator (IPG) (non-rechargeable or rechargeable)
• A clinician programmer
• A patient controller 
• A lead kit and extension kit 

This supplement expands the indications for use of these devices to include an additional option for patients who are diagnosed with essential tremor or tremor  due to Parkinsonian’s Disease not adequately controlled by medication and where the tremor accounts for a significant disability that interferes with daily activities. 

How does it work?  

A pulse generator implanted in the body sends electrical pulses through the leads (wires) to the ventral intermediate nucleus (VIM) of the thalamus of the brain to reduce tremor in the upper extremity of patients who are diagnosed with essential tremor or parkinsonian tremor not adequately controlled by medications. Patients can manage the electrical current’s intensity and frequency with the patient controller. 

When is it used?  

The Vercise™ PC, Vercise Gevia™ and Vercise Genus™ DBS Systems are used by patients as an additional therapy to reduce essential tremor or parkinsonian tremor when it is not well controlled by medication.  

What will it accomplish?  

The Vercise™ PC, Vercise Gevia™ and Vercise Genus™ DBS Systems are intended to reduce tremors and involuntary muscle movements in the upper extremity of patients who are diagnosed with essential tremor or Parkinson’s disease. 

When should it not be used?  

The Vercise™ PC and Vercise Gevia™ DBS Systems should not be used in patients who are unable to operate them. These systems are not recommended for patients who are poor surgical candidates or who have undergone unsuccessful test stimulation. 

Once a patient has received the IPG implant, they must avoid exposure to devices that create or disrupt electrical current within the body, such as: 

• Short wave diathermy
• Microwave diathermy
• Therapeutic ultrasound diathermy
• Electroconvulsive therapy (commonly referred to as electroshock therapy)
• Transcranial magnetic stimulation (TMS)
• Magnetic Resonance Imaging (MRI)

Additional information (including warnings, precautions, and adverse events):  

• Summary of Safety and Effectiveness Data 
• Patient Labeling 
• Clinician Labeling 
• PMA Database Entry