Devices

FDA-approved vagus nerve stimulation system for refractory epilepsy with the SenTiva generator that senses heart rate. Values come from the FDA supplement records, summary and LivaNova's spec sheet.

Catalog specification sheet - Peripheral nerve

LivaNova VNS Therapy SenTiva

Primary source →

Record ID
BTSD-FDA-0008
Reviewed
2026-10-08
Interface
pni
Evidence stage
human

Independent, source-linked catalog sheet. Not a manufacturer-issued datasheet, regulatory decision or instructions for clinical use. Human evidence does not establish approval. Source-specific restrictions, conflicts and missing specifications are retained below.

LivaNova VNS Therapy SenTiva

The VNS Therapy System is the longest-running implanted vagus nerve stimulator, approved under PMA P970003. This sheet is scoped to the SenTiva Model 1000 generator and the lead models listed with it. Unknown cells stay Unreported.

Identity

FieldValue and source scope
DeviceLivaNova VNS Therapy System: SenTiva Model 1000 generator (with SenTiva Duo), Lead models 302, 303 and 304, Model 2000 wand, Model 3000 programmer [1][2][3]
ManufacturerLivaNova USA, Inc., Houston, Texas (formerly Cyberonics) [1][3]
Interface classImplanted pulse generator with a helical lead on the left cervical vagus nerve [2][3]
OriginCommercial FDA-approved device, PMA P970003 [1][2]
First demonstratedUnreported
First human implantUnreported
Species studiedUnreported
Regulatory statusPMA P970003. LivaNova announced SenTiva approval on October 9, 2017 (release page read, text not extracted); S218 decision July 27, 2018 approved Model 1000 SenTiva, wand and programmer version 1.5 updates. The S207 record (decision June 23, 2017) and its SSED are the indication and contraindication source [1][2][4]
FunctionAdjunctive therapy reducing seizure frequency in patients 4 years and older with partial onset seizures refractory to antiepileptic medications; SenTiva also provides responsive stimulation to heart rate increases and logs low heart rate and prone position events [1][2]
Target tissueLeft vagus nerve; contraindicated after bilateral or left cervical vagotomy [2][3]

Geometry and architecture

FieldValue and source scope
Interface typeVNS Therapy lead attached to the left vagus nerve; the SSED and spec sheet name models 302, 303 and 304 [2][3]
Array layoutUnreported
Electrode countUnreported
PitchUnreported
Electrode lengthsUnreported
Shank width and thicknessUnreported
Tip and exposed site geometryUnreported
Contact coatingUnreported
InsulationUnreported
Insertion methodUnreported
Anchoring and fixationUnreported

Electrode and channel physics

FieldValue and source scope
Exposed site areaUnreported
Electrode materialUnreported
Impedance (with measurement frequency)Unreported
Noise floor or SNRUnreported
Recording modalityUnreported
Sampling rateUnreported
Stimulation capabilityOutput 0-2.0 mA in 0.125 mA steps and 2.0-3.5 mA in 0.25 mA steps; frequency 1, 2, 5, 10, 15, 20, 25, 30 Hz; pulse width 130, 250, 500, 750, 1000 us; signal ON 7-60 s, OFF 0.2 min to 180 min; magnet and AutoStim modes; day-night and scheduled programming [3]
Charge injection limitUnreported
Reference and groundUnreported

Tissue interface and bioresponse

FieldValue and source scope
Target tissueUnreported
Insertion trauma and BBB disruptionUnreported
Vascular disruption riskUnreported
Micromotion sensitivityUnreported
Gliosis and encapsulationUnreported
Neuron loss near sitesUnreported
Foreign-body response mitigationUnreported
Typical failure modesUnreported

System architecture

FieldValue and source scope
Onboard electronicsProgrammable pulse generator with heart rate sensing for AutoStim and seizure detection settings [3]
Data pathWand (Model 2000) communicates wirelessly with the programmer (Model 3000) at distances up to 3 meters under most conditions [5]
Telemetry bandwidthUnreported
Sampling rateUnreported
PowerLithium carbon monofluoride primary cell, 3.3 V open circuit, 1 Ah rated capacity [3]
Thermal managementUnreported
Packaging and hermeticityUnreported
MRI compatibilityUnreported
Surgical complexityUnreported
Output connectorsUnreported

Performance envelope

FieldValue and source scope
Acute yieldUnreported
Chronic yieldUnreported
Stability over timeUnreported
LongevityUnreported
Revision and explant experienceUnreported
Adverse eventsNot extracted here
Notable demonstrationsUnreported

Clinical and preclinical evidence

FieldValue and source scope
Human subjectsUnreported
Preclinical cohortUnreported
Follow-up durationUnreported
IndicationsPatients 4 years and older with partial onset seizures refractory to antiepileptic medications [1]
Trials and registriesNot extracted here
Primary outcomesUnreported
Key limitationsThe S207 SSED is a multi-model summary and the clinical efficacy sections were not read. Contraindications include diathermy and prior bilateral or left cervical vagotomy [2]

Engineering tradeoffs

FieldValue and source scope
StrengthsUnreported
LimitationsDiathermy contraindicated; heating hazard if any portion of the system remains implanted [2]
Scaling constraintsUnreported

Version boundary

The S207 SSED lists several earlier generators (Models 102 to 106). SenTiva Model 1000 is the generator described here; the S218 update to software version 1.5 was approved July 27, 2018. Newer supplements were not reviewed.

References

  1. FDA PMA P970003/S207 record.
  2. FDA summary of safety and effectiveness data, P970003/S207.
  3. LivaNova SenTiva M1000 generator spec sheet.
  4. FDA PMA P970003/S218 record.
  5. LivaNova SenTiva technical guide.