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 Deep Brain Stimulation (DBS) System
PMA Applicant: Boston Scientific Corporation
Address: 25155 Rye Canyon Loop, Valencia, CA 91355
Approval Date: 12/8/2017
Approval Letter: https://www.accessdata.fda.gov/cdrh_docs/pdf15/P150031a.pdf
What is it? The Vercise DBS System is a neurostimulator used to reduce motor symptoms associated with Parkinson's disease. The system includes a 16-channel, rechargeable, implanted stimulator that is connected to two DBS extensions and two DBS leads. The implanted stimulator generates an electrical pulse that is carried through the lead extensions to the lead and delivered to the subthalamic nucleus in the brain.
How does it work? The Vercise DBS system is designed to deliver low-intensity electrical pulses to the brain in various combinations of amplitude, pulse width, and frequency. The DBS Extensions are used to connect the DBS leads to the stimulator implanted near the collarbone (clavicle). The Stimulator is controlled by a handheld remote control, and is programmed by a clinician programmer running the Bionic Navigator™ Software. Every so often, the rechargeable stimulator battery must be replenished with a radiofrequency (RF) charging device provided in the charging kit.
When is it used? The Vercise DBS System is used as an adjunctive therapy in reducing some of the symptoms of moderate to advanced levodopa-responsive Parkinson's Disease that is not adequately controlled with medication. The Vercise DBS System will stimulate the subthalamic nucleus bilaterally.
What will it accomplish? The Vercise DBS System will reduce motor symptoms associated with moderate to advanced levodopa responsive Parkinson's disease.
When should it not be used? The Boston Scientific Vercise DBS System, or any of its components, is contraindicated for:
- Diathermy: Shortwave, microwave, and/or therapeutic ultrasound diathermy. The energy generated by diathermy can be transferred to the Vercise DBS System, causing tissue damage at the contact site resulting in severe patient injury or death.
- Electroconvulsive therapy (ECT) and transcranial magnetic stimulation (TMS): The safety of these therapies in patients implanted with the Vercise DBS System has not been established. It is possible that the energy generated by these therapies can be transferred to the Vercise DBS System, causing tissue damage that may result in severe patient injury or death.
- Magnetic Resonance Imaging (MRI): Patients implanted with the Vercise DBS System should not be subjected to MRI. MRI exposure may result in a) dislodgement of implanted components, b) heating of the contacts or other system components, causing permanent tissue lesioning, c) damage to the Stimulator's electronics, current induction through the DBS Leads and Vercise DBS System causing unpredictable levels of stimulation, d) distortion of the diagnostic image, e) Personal injury or even death.
- Patient Incapability: Patients who are unable to properly operate the Remote Control and Charging System should not be implanted with the Vercise DBS System.
- Poor Surgical Candidates: The Vercise DBS System is not recommended for patients who are poor surgical candidates.
- Unsuccessful Test Stimulation. The Vercise DBS System should not be used in patients who experience unsuccessful test stimulation.
Additional information (including warnings, precautions, and adverse events): Summary of Safety and Effectiveness Data and labeling are available online.