Vivistim Paired VNS System by MicroTransponder: status and timeline

Vivistim Paired VNS System

Restore arm function in stroke patients by pairing vagal stimulation with physical therapy to amplify neuroplasticity and motor learning.

DeployStage 4 of 5

FDA approved for stroke arm weakness since 2021. Expanding to other motor recovery indications.

Updated 27 Aug 2021Checked 11 Oct0 updates this week

Milestones

Next · Expansion trials in additional motor indications

FDA Premarket Approval27 Aug 2021Complete.
First patients treated with approved system2021Complete.
Clinical data shows 2-3x functional gain vs. rehab2023Complete.
American Heart Association partnership16 Jan 2026Complete.
Expansion trials in additional motor indicationsTarget 2026Current milestone.

Most important updates

FDA grants Premarket Approval to Vivistim Paired VNS for chronic stroke arm weakness27 Aug 2021

Upcoming

2026Expansion trials in additional motor indications (next)

Current obstacles

Identifying optimal rehabilitation timingPeak neuroplasticity is first 6-12 months post-stroke; many patients seek treatment years later when response is limited.
Patient selection and outcome predictionNot all stroke patients respond; predicting responders before implantation remains unsolved.
Therapist training in pairing protocolVNS works only when precisely paired with specific rehab movements; training therapists is needed for widespread adoption.

Physics limits

Stroke destroys neural tissue permanentlyVNS enhances recovery of remaining pathways but cannot restore lost neurons or function beyond neuroplasticity.
Chronic muscle denervationLong-denervated muscles atrophy; strength gains plateau when muscle tissue is lost even with optimized therapy.

How it works

3 parts

Vagal stimulation

Brief electrical pulses on the vagus nerve

Implant delivers short pulses to the vagus nerve, triggering parasympathetic activation and neuromodulator release.

Neuromodulator release

Amplifying learning signals during motor therapy

Vagal stimulation triggers norepinephrine and acetylcholine release, which enhance the brain's motor learning during physical therapy movements.

Timing with therapy

Pairing with goal-directed movement practice

Stimulation during targeted motor tasks strengthens movement circuits through Hebbian plasticity of active pathways.

Spec sheet

Spec	Vivistim Paired VNS System
Functional gain vs. rehab alone	2-3x^R (reported)
FDA approval year	2021^R (reported)
FDA-approved indication	Chronic post-stroke arm weakness^R (reported)

^R reported by the company

Papers & demos

2 items

2026talk
Partnership with American Heart Association Center for Health Tech (opens biospace.com)Positions Vivistim in rehabilitation innovation network to expand to other motor recovery indications.
24 Apr 2021demo
Pivotal trial results published in The LancetVNS-REHAB trial showed paired stimulation produces 2-3x greater gains in arm function than rehabilitation alone.

Update log

1 update

Fri 27 Aug 2021

Major: FDA grants Premarket Approval to Vivistim Paired VNS for chronic stroke arm weaknessPressRegulatory

About MicroTransponder

The team behind Vivistim Paired VNS System

MicroTransponder

Vivistim, VNS, vagus stimulation, stroke

MicroTransponder develops implantable vagus nerve stimulation paired with rehabilitation for stroke recovery. Vivistim is the only FDA-approved implant for chronic arm weakness after stroke.

Vivistim Paired VNS is the only FDA-approved implant for chronic post-stroke arm weakness, approved in 2021.
Paired stimulation during therapy increases arm function 2-3x compared to rehabilitation alone.
American Heart Association partnership to expand VNS-based recovery therapies to multiple motor indications.

microtransponder.com (opens microtransponder.com)Company profile →

Founded: 200719 yrs
Headquarters: United States
Status: Private
Valuation: private
Works in: NeurotechStimulation therapies
Coverage: 1 program · 2 updateslatest 16 Jan 2026checked 11 Oct
Partners: American Heart Association

Spec

Vivistim Paired VNS System

Functional gain vs. rehab alone

2-3x^R (reported)

FDA approval year

2021^R (reported)

FDA-approved indication

Chronic post-stroke arm weakness^R (reported)