BCI.INTEL
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Terminal/Device DB/Infinity DBS System
dbsPMA-approvedapproved

Infinity DBS System

Implant Type
dbs
Electrodes
8
Channels
8
FDA Status
PMA-approved
Clinical Stage
Post-market (FDA PMA approved February 2016)
Status
approved
About

The Abbott Infinity DBS system features directional lead technology with segmented electrode contacts that allow physicians to steer current laterally, avoiding stimulation of structures that cause side effects. The first FDA-approved DBS system with directional stimulation capability. The system pairs with an iPhone app for patient symptom tracking and stimulation adjustment within clinician-defined ranges. Abbott's Sensing & Insights technology captures local field potential data to support personalized, data-driven programming.

Target Conditions
Parkinson's diseaseessential tremorOCDepilepsy
FDA Regulatory Pathway
No FDA Regulatory Status

This device does not have a current FDA designation. It may be a research tool, preclinical device, or consumer product not subject to FDA medical device regulation.

FDA Device Regulatory Guidance ↗
Other dbs Devices