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Penumbra System · 1 trial · 1 indication
Revascularization is defined by a Thrombolysis in Myocardial Infarction (TIMI) score of 2 or 3 following use of the Penumbra System. TIMI scores are used to describe blood flow at the treated vessel with 0 designating no flow and 3 for normal flow.
| Name | Type | Description |
|---|---|---|
| Penumbra System | DEVICE | - |
Inclusion Criteria: * Clinical signs consistent with acute ischemic stroke * 18 to 79 years of age * Neurological deficit resulting in an NIH Stroke Scale (NIHSS) score \> 8 * TIMI 0 or TIMI I flow in vessels accessible to the Penumbra System * Signed informed consent * Present within 8 hours of st...
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The Penumbra System is an investigational medical device being studied for use in stroke. It is designed to remove blood clots from the brain's blood vessels in patients experiencing an acute ischemic stroke. The device is currently in clinical development and has not been approved by the FDA.
The Penumbra System is developed by Penumbra, Inc., a company publicly traded under the ticker symbol PEN. The company is conducting clinical trials to evaluate the safety and effectiveness of the device for the treatment of stroke.
The Penumbra System is in Phase 2 clinical development. A Phase 2 study has been completed to assess its safety and effectiveness in stroke patients. The device is investigational and has not received FDA approval.
The Penumbra System has one completed clinical trial, identified as NCT00334061, titled 'Study to Assess the Safety and Effectiveness of the Penumbra System.' This Phase 2 study enrolled 125 participants in the United States and evaluated the device for the treatment of stroke.
The Penumbra System is not FDA approved. It is an investigational device currently in Phase 2 clinical development. A completed clinical trial has assessed its safety and effectiveness, but regulatory approval has not been granted.