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Terminal/Device DB/SenSight Directional DBS Lead System
dbsPMA-approvedapproved

SenSight Directional DBS Lead System

Implant Type
dbs
Electrodes
8
Channels
8
FDA Status
PMA-approved
Clinical Stage
Post-market (FDA approved June 2021)
Status
approved
About

The SenSight Directional Lead System is the first DBS lead to combine directional stimulation with sensing capability. Directional contacts allow customization of stimulation field size, shape, and direction, while integration with the Percept PC/RC neurostimulators enables enhanced detection of local field potentials — signals 1 million times smaller than DBS stimulation pulses. The lead provides 57% improved tip stability versus legacy leads (animal model data). SenSight is the only DBS directional lead system with 3T and 1.5T MR Conditional eligibility. The ADAPT-PD trial is evaluating adaptive DBS with automated stimulation adjustment based on patient state.

Target Conditions
Parkinson's diseaseessential tremordystoniaepilepsy
Milestones
2020-09CE Mark received for SenSight Directional Lead System
2021-06FDA approval and first US implants
2025-01ADAPT-PD adaptive DBS trial initiated
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