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Penumbra
Summary: The Penumbra Pump Max is a mechanical thrombectomy device used primarily for venous thrombectomy. Key evidence highlights its efficacy in reducing procedure time and improving outcomes in acute ischemic stroke treatment.
FDA Clearance Information
Pathway
510K
Number
K122756 ↗
Decision Date
October 2, 2012
Product Code
JCX
Device Class
Class 2
Evidence
0 studies
The Penumbra Pump Max was cleared by the FDA via the 510(k) pathway on October 2, 2012. It is manufactured by Penumbra and classified as a Class 2 device.
What It Is
The Penumbra Pump Max is a mechanical thrombectomy device designed to remove thrombi from blood vessels. It operates by providing aspiration power to remove clots, primarily used in the treatment of acute ischemic stroke.
Clinical Applications
Commonly used in scenarios requiring rapid clot removal, such as acute ischemic stroke, the device is employed in mechanical thrombectomy procedures to restore blood flow in occluded vessels.
Evidence Summary
The literature includes six studies, comprising various study types such as RCTs and retrospective analyses, published between 2016 and 2020. These studies evaluate the device's technical and clinical outcomes.
Reported Outcomes
Published studies report that the Penumbra Pump Max, when used with larger bore catheters, is associated with shorter procedure times and improved clinical outcomes in acute ischemic stroke. The device's efficacy in achieving reperfusion is highlighted in several studies.
Safety Profile
Reported complications include challenges in navigating tortuous arteries, as noted in studies evaluating the use of coaxial systems with balloon catheters. No significant adverse events directly attributed to the device were reported in the provided evidence.
Evidence Limitations
The evidence is limited by the lack of large-scale randomized controlled trials directly comparing the Penumbra Pump Max to other thrombectomy devices. Further research is needed to explore long-term outcomes and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Penumbra Pump Max?
The device is indicated for mechanical thrombectomy in cases of acute ischemic stroke to restore blood flow in occluded vessels.
What outcomes have been reported in clinical studies?
Studies report improved procedure times and clinical outcomes, particularly when used with larger bore catheters in acute ischemic stroke treatment.
What complications have been reported?
Safety data indicate potential navigation challenges in tortuous arteries, but no significant adverse events directly linked to the device were reported.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.