A groundbreaking real-world study has demonstrated significant improvements in stroke recovery outcomes using Microtransponder's Vivistim device, as presented at the 2025 International Stroke Conference (ISC) in Los Angeles. The study represents the largest cohort of stroke survivors treated with paired vagus nerve stimulation (VNS) therapy to date.
Clinical Outcomes and Patient Demographics
The study included 25 post-acute stroke patients with moderate-to-severe motor impairments in their arms and hands. Dr. Ronald Benitez, a neurosurgeon at Atlantic Brain and Spine, reported that 22 patients successfully completed the six-week therapy protocol. The patient cohort ranged in age from 40 to 80 years, with a mean age of 62.6 years, and their time post-stroke varied from one to eleven years.
Results showed a remarkable improvement in upper extremity function, with mean Fugl-Meyer Assessment-Upper Extremity (FMA-UE) scores increasing by 9.53 points, from an average baseline of 33 to a post-therapy score of 43. Notably, long-term follow-up data revealed sustained progress, with one patient demonstrating continued improvement in timed tasks even after 22 months.
Safety Profile and Implementation
The Vivistim device, which received FDA Breakthrough Device designation, demonstrated an excellent safety profile. Dr. Benitez reported no infections or surgical complications during the standard VNS implant procedures, highlighting the therapy's safety and accessibility for medical professionals.
"These outcomes are especially compelling considering patients showed positive responses to paired VNS therapy with Vivistim despite an average of 3.6 years post-stroke," stated Dr. Benitez. He emphasized that these results support the efficacy of this innovative treatment in the chronic stroke population.
Market Impact and Adoption
The therapy has gained significant traction in the medical community, with implementation across 20% of Joint Commission Comprehensive Stroke Centers and 50% of Becker's 2024 100 Great Neuro and Spine Programs. This rapid adoption reflects the medical community's recognition of Vivistim's potential in addressing a long-standing gap in stroke recovery treatment.
Richard Foust, CEO of Microtransponder, noted the emergence of chronic stroke recovery as a key focus area at ISC, stating, "Vivistim is the first clinically proven innovation in 30 years that helps increase neuroplasticity for ischaemic stroke survivors."
Treatment Mechanism and Benefits
The Vivistim system works by pairing VNS with occupational or physical therapy, demonstrating two to three times greater improvement in hand and arm function compared to traditional stroke therapy alone. This paired approach represents a significant advancement in neurorehabilitation, offering new hope for stroke survivors who previously had limited treatment options.
