Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Inspire Upper Airway Stimulation System · 1 trial · 1 indication
Demonstrate at least a 50% responder rate at the 12-month follow-up visit. An Inspire therapy AHI responder was defined as a subject who experienced at least a 50% reduction in AHI from baseline and had an AHI of less than 20 at the 12-month follow-up.
Demonstrate at least a 50% responder rate at the 12-month follow-up visit. An Inspire therapy ODI responder was defines as a subject who experienced at least a 25% reduction in ODI from baseline.
The primary safety objective of this pivotal trial was to evaluate safety via a description of all reported adverse events. Per the IDE-approved protocol, no formal statistical hypothesis was tested as part of the safety assessment.
| Arm | Type | Description |
|---|---|---|
| Inspire Therapy | EXPERIMENTAL | Inspire Upper Airway Stimulation System, is a permanent, implantable therapy device, which consists of three implantable components: IPG, stimulation lead, and a sensing lead. In additional the patient receives a remote to activate the therapy. |
| Name | Type | Description |
|---|---|---|
| Inspire Upper Airway Stimulation System | DEVICE | Inspire Upper Airway Stimulation System, is a permanent, implantable therapy device, which consists of three implantable components: IPG, stimulation lead, and a sensing lead. In additional the patient receives a remote to activate the therapy. |
Inclusion Criteria: * Likely suffer moderate-to-severe OSA based on history and physical * Have failed or have not tolerated CPAP treatment * Willing and capable of providing informed consent * Willing and capable to have stimulation hardware permanently implanted, and to use the patient programmer...
Inspire Upper Airway Stimulation System is used for obstructive sleep apnea. It is an investigational device being studied for this condition. The system is designed to deliver stimulation therapy to reduce apnea events during sleep.
Inspire Upper Airway Stimulation System is developed by Inspire Medical Systems, Inc., a company traded under the ticker INSP. The company is conducting clinical research to evaluate the device for the treatment of obstructive sleep apnea.
Inspire Upper Airway Stimulation System is in Phase 3 clinical development. It is an investigational device and has not been approved by the FDA. The Phase 3 trial has been completed, and the device remains under clinical investigation.
Inspire Upper Airway Stimulation System is associated with one completed Phase 3 trial, NCT01161420, titled "Stimulation Therapy for Apnea Reduction (www.theSTARtrial.com)." The trial enrolled 929 participants with obstructive sleep apnea across the United States, Belgium, France, Germany, and the Netherlands.
Yes, Inspire Upper Airway Stimulation System is the device evaluated in the STAR trial, formally known as NCT01161420, "Stimulation Therapy for Apnea Reduction." The trial was a Phase 3, uncontrolled study that enrolled 929 adults with obstructive sleep apnea.