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Spinal cord stimulation system · 1 trial · 1 indication
Intra and post procedure adverse events, exercise and functional capacity, left ventricular structure and function, inflammatory condition, and quality of life.
| Arm | Type | Description |
|---|---|---|
| Spinal cord stimulation | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Spinal cord stimulation system | DEVICE | An implantable pulse generator (IPG) will deliver low-intensity electrical pulses which travel from the IPG through the leads to the electrodes positioned at the selected nerve fibers to provide the therapeutic stimulation. |
Inclusion Criteria: * Patients has a LVEF between 20% and 35% * Patient is in NYHA Class III or in Ambulatory Class IV * Patient has had a SJM implantable cardioverter defibrillator (ICD) device or a SJM CRT-D device implanted \>90 days and is receiving stable medical therapy for HF (\>90 days) at ...
The spinal cord stimulation system is used for systolic heart failure, a condition in which the heart's lower chambers do not pump blood effectively. It is an investigational therapy being studied to determine whether electrical stimulation of the spinal cord can improve heart function in patients with this condition.
Abbott Laboratories (NYSE: ABT) is developing the spinal cord stimulation system. The company is conducting clinical research to evaluate the device as a potential treatment for systolic heart failure.
The spinal cord stimulation system is in Phase 2 clinical development. It is an investigational device, meaning it has not been approved for commercial use and is still being evaluated in clinical trials for safety and effectiveness in patients with systolic heart failure.
The spinal cord stimulation system has been studied in one completed Phase 2 clinical trial, NCT01362725, titled "Spinal Cord Stimulation For Heart Failure." The trial enrolled 20 participants with systolic heart failure across sites in Australia, Hong Kong, and Japan.
The spinal cord stimulation system is not FDA approved. It is an investigational device currently in Phase 2 clinical development for systolic heart failure. The completed trial NCT01362725 evaluated the device in 20 patients, but regulatory approval has not been granted.