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Equilia Vagal Nerve Stimulation · 1 trial · 1 indication
Adverse device effects will be sub-classified into device-related or procedure-related, when the adverse event has a generic cause independent from the device itself and occurs within 30 days of the implant procedure.
| Arm | Type | Description |
|---|---|---|
| Treated with Equilia system | EXPERIMENTAL | Implantation and activation of the Vagus Nerve Stimulator, nerve electrode and cardiac lead |
| Name | Type | Description |
|---|---|---|
| Equilia® Vagal Nerve Stimulation | DEVICE | Vagal Nerve Stimulation synchronized with cardiac activity |
Inclusion Criteria: 1. Left ventricular dysfunction of ischemic or idiopathic dilated cardiomyopathy etiology, characterized by LVEF \< 40% 2. Chronic heart failure with symptoms characterized by NYHA functional class II or III at the time of enrollment despite optimal drug regimen 3. Optimal drug ...
Equilia Vagal Nerve Stimulation is an investigational therapy being studied for heart failure with reduced ejection fraction. It is a vagal nerve stimulation approach intended for patients with this type of heart failure. The therapy is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
Equilia Vagal Nerve Stimulation is being developed by LivaNova PLC, a company traded on the NASDAQ under the ticker LIVN. LivaNova is the developer of this investigational therapy for heart failure with reduced ejection fraction.
Equilia Vagal Nerve Stimulation is in Phase 2 clinical development. It is an investigational therapy for heart failure with reduced ejection fraction and is not yet approved for commercial use. The therapy has completed one Phase 2 clinical trial.
Equilia Vagal Nerve Stimulation has been studied in one completed Phase 2 clinical trial, identified as NCT02133013. This trial, titled "VAgal Nerve Stimulation: safeGUARDing Heart Failure Patients," enrolled 15 participants with heart failure with reduced ejection fraction across Belgium, France, Norway, and Serbia.
Equilia Vagal Nerve Stimulation is not FDA approved. It is an investigational therapy currently in Phase 2 clinical development for heart failure with reduced ejection fraction. The therapy has completed a single Phase 2 trial but has not yet received regulatory approval.
Equilia Vagal Nerve Stimulation is a specific form of vagal nerve stimulation being developed by LivaNova PLC for heart failure with reduced ejection fraction. While it uses the general approach of vagal nerve stimulation, it is a distinct investigational therapy in clinical development.