Overview
- StimCardio reported positive results from its NeuroPulse pilot study evaluating non-invasive median nerve stimulation (MNS) after atrial fibrillation (AF) ablation.
- The study found 90.0% freedom from atrial arrhythmias at six months with MNS versus 80.8% with sham, while recurrent events were significantly reduced in a sensitivity analysis.
- The company plans to advance its investigational Rhyvive wearable device toward a pivotal trial.
The News
StimCardio Medical announced results from the randomized, double-blind, sham-controlled NeuroPulse pilot study evaluating non-invasive median nerve stimulation following AF ablation. The study included 77 patients randomized to active MNS or sham treatment, with therapy initiated within 48 hours of ablation and continued for six months.
At six months, 90.0% of patients receiving MNS remained free from atrial arrhythmias compared with 80.8% with sham, although this difference was not statistically significant. A post-blanking sensitivity analysis recorded 12 recurrent events with MNS versus 28 with sham (p = 0.025). No MNS- or device-related serious adverse events were reported.
Industry Perspective
While advances such as pulsed field ablation have improved AF treatment, recurrent arrhythmias remain a challenge for some patients. NeuroPulse takes a different approach by targeting peripheral neural pathways involved in autonomic regulation rather than further ablating cardiac tissue.
Strategic Impact
The findings provide an early clinical signal supporting wearable neuromodulation as a potential adjunct to AF ablation. StimCardio is developing Rhyvive™, an investigational physician-prescribed wrist-worn device designed to deliver personalized neuromodulation under clinical oversight, with larger trials planned to further evaluate its potential.
Source: PRnewswire
