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:  Abbott Infinity^TM DBS Neurostimulation System
PMA Applicant:  Abbott Medical
Address:  6901 Preston Road, Plano, TX, 75024
Approval Date:   January 2, 2020
Approval Letter:  Approval Order

What is it?  The Abbott Infinity^TM DBS Neurostimulation System is an implantable device that delivers low-intensity electrical pulses to nerve centers in the brain using different combinations of amplitude, pulse width, and frequency. This system consists of the following three components:

1. A non-rechargeable, implantable pulse generator (IPG)
2. A patient controller app
3. A lead kit and extension kit

This supplement expands the indications for use of this device to include an additional option of lead implant location in the brain 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 the leads (wires) to the brain to reduce tremor and involuntary muscle movement. Patients can manage the electrical current’s intensity and frequency via the app-based controller.

When is it used?  The InfinityTM DBS Neurostimulation System is used by patients as an adjunctive therapy in reducing the signs and symptoms of advanced levodopa-responsive Parkinson’s disease that not adequately controlled with medication.  This system stimulates brain targets to manage the severity of tremor.

What will it accomplish?  The Infinity^TM DBS Neurostimulation System is intended as an adjunctive treatment to reduce tremors associated with advanced levodopa-responsive Parkinson’s disease and tremors of the upper extremities in adults with essential tremor.

When should it not be used?  The Infinity^TM DBS Neurostimulation System should not be used in patients who are unable to operate it. 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
• Electroshock therapy
• Transcranial magnetic stimulation (TMS)

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

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