Vercise PC, Vercise Gevia, and Vercise Genus Deep Brain Stimulation Systems – P150031/S064
This is a brief overview of information related to the FDA’s approval to market this product. 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 the 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: February 29, 2024
Approval Letter: Approval Order
What is it?
The Vercise PC, Vercise Gevia, and Vercise Genus Deep Brain Stimulation (DBS) Systems are implantable devices that deliver low-intensity electrical pulses to nerve centers in the brain. These DBS systems consist of the following components:
- An implantable pulse generator (IPG) (non-rechargeable or rechargeable)
- A clinician programmer (a program on a tablet that provides a health care provider information)
- A patient controller
- A lead kit and extension kit
This supplement expands the Indications for Use to include an option of two-sided stimulation for people who are diagnosed with essential tremor not adequately controlled by medication and where the tremor creates a significant inability to function.
A pulse generator implanted in the body sends electrical pulses through wires (leads) to a specific part of the brain (the ventral intermediate nucleus (VIM) of the thalamus) to reduce tremor in the arms and hands. People can manage the electrical current’s intensity and frequency with the patient controller.
The Vercise PC, Vercise Gevia, and Vercise Genus DBS Systems are used as an additional therapy to help reduce some of the symptoms or tremors associated with essential tremor not adequately controlled by medication, and where the tremor creates a significant inability for a person to function.
The Vercise PC, Vercise Gevia, and Vercise Genus DBS Systems are intended to reduce tremors in the upper arms and hands not adequately controlled by medication.
The Vercise PC, Vercise Gevia, and Vercise Genus DBS Systems should not be used in people who are unable to operate them. Once a person has received the IPG implant, they must avoid exposure to devices that create or disrupt electrical charge within the body, such as:
- Therapies that use high-frequency electrical current to stimulate heat, including short wave, microwave, and therapeutic ultrasound diathermy
- Electroshock therapy
- Transcranial magnetic stimulation (TMS) (a noninvasive procedure that uses a magnetic field to stimulate nerve cells in the brain)
- Magnetic Resonance Imaging (MRI)
The Vercise PC, Vercise Gevia, and Vercise Genus DBS Systems should also not be used in people who:
- Are not good candidates for surgery
- Have an unsuccessful test stimulation