The Abbott Infinity DBS system (developed by St. Jude Medical, acquired by Abbott in 2017) features directional lead technology with segmented electrode contacts that allow physicians to steer current laterally, avoiding stimulation of structures that cause side effects. The system pairs with an iPhone app, enabling patients to track symptoms and adjust stimulation parameters within clinician-defined ranges. The Infinity system was the first FDA-approved DBS system with directional stimulation capability. Abbott's Sensing & Insights technology captures local field potential data to support personalized, data-driven programming.
The device has received Pre-Market Approval (PMA) from the FDA, the most stringent device marketing pathway. PMA approval means FDA has found there is reasonable assurance the device is safe and effective.
FDA Device Regulatory Guidance ↗