Penumbra System (Reperfusion Catheter RED 72)
Penumbra, Inc.The Penumbra System (Reperfusion Catheter RED 72) is a catheter-based device designed to remove blood clots in the brain's large vessels to treat acute ischemic stroke. It uses aspiration to restore blood flow in blocked intracranial vessels during neurointerventional procedures, guided by fluoroscopy. This device helps clinicians revascularize patients who are ineligible or have failed thrombolytic drug therapy, improving stroke treatment outcomes.
Intended Use
The Penumbra System is indicated for revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease within 8 hours of symptom onset, especially for patients ineligible or who failed thrombolytic drug therapy.
Technology
The system includes a reperfusion catheter, 3D revascularization device, aspiration pump, tubing, and separator. It works by delivering aspiration via a pump to the thrombus site to remove clots. The catheter is navigated through guide catheters/sheaths under fluoroscopy to the site of occlusion. Optional SENDit technology is available for the catheter. Devices are constructed from materials like stainless steel and PTFE, with hydrophilic coating and are visible under fluoroscopy.
Performance
Performance testing included dimensional, friction, radiopacity, simulated use tests, and biocompatibility per ISO standards. The device met all acceptance criteria, demonstrating safety and effectiveness. No clinical or animal studies were conducted as bench and biocompatibility testing were sufficient for verification and validation.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/18/2024
7 months - 2
FDA Approval
2/13/2025
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