This is a brief overview of information related to 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 FDA’s approval.
Product Name: Vercise™ PC and Vercise Gevia™ Deep Brain Stimulation (DBS) Systems
PMA Applicant: Boston Scientific Corporation
Address: 25155 Rye Canyon Loop, Valencia, CA 91355
Approval Date: December 29, 2020
Approval Letter: Approval Letter
What is it?
The Vercise™ PC and Vercise Gevia™ DBS Systems are implantable devices that deliver low-intensity electrical pulses to nerve centers in the brain using different combinations of amplitude, pulse width, and frequency. The systems consist of three components:
- An implantable pulse generator (IPG) (non-rechargeable or rechargeable)
- A patient controller
- A lead kit and extension kit
This supplement expands the indications for use of these devices to include use as an additional option for patients with advanced levodopa-responsive Parkinson’s disease that is not adequately controlled by medications.
How does it work?
A pulse generator implanted in the body sends electrical pulses through wires (leads) connected to specific parts of the brain (either the subthalamic nucleus or globus pallidus internus) to reduce tremor and involuntary muscle movement. Patients can manage the electrical current’s intensity and frequency with the controller.
When is it used?
The Vercise™ PC and Vercise Gevia™ DBS Systems are used by patients as an additional therapy to reduce signs and symptoms of advanced levodopa-responsive Parkinson’s disease when it is not well controlled by medication.
What will it accomplish?
The Vercise™ PC and Vercise Gevia™ DBS Systems are intended to reduce tremors and involuntary muscle movements from advanced levodopa-responsive 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 the controller
- Are not good candidates for surgery
- Have an 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:
- Therapies that use high-frequency electrical current to stimulate heat, including short wave, microwave, and therapeutic ultrasound diathermy
- Electroshock therapy
- Transcranial magnetic stimulation (TMS)
- Magnetic resonance imaging (MRI)