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penumbra embolectomy aspiration system
Penumbra
Summary: The Penumbra Embolectomy Aspiration System is a mechanical thrombectomy device used primarily for venous thromboembolism. Key evidence highlights its effectiveness in large vessel occlusion stroke thrombectomy.
FDA Clearance Information
Pathway
510K
Number
K121917 ↗
Decision Date
September 19, 2012
Product Code
QEW
Device Class
Class 2
Evidence
0 studies
The Penumbra Embolectomy Aspiration System was cleared by the FDA via the 510(k) pathway on September 19, 2012. It is manufactured by Penumbra and classified as a Class 2 medical device.
What It Is
The Penumbra Embolectomy Aspiration System is designed for mechanical thrombectomy, utilizing aspiration to remove thrombi from blood vessels. It is intended for use in treating venous thromboembolism and large vessel occlusions.
Clinical Applications
Commonly used in acute ischemic stroke interventions, the device is applied in scenarios requiring rapid thrombus removal from large vessels, particularly in cases of acute limb ischemia and high-risk pulmonary embolism.
Evidence Summary
The literature includes 14 studies, comprising randomized controlled trials, case series, and registry analyses, with publication dates ranging from 2024 to 2025. These studies assess the device's safety and efficacy in various clinical settings.
Reported Outcomes
Published studies report that the Penumbra Embolectomy Aspiration System is effective in achieving rapid recanalization in large vessel occlusion strokes. The device demonstrates favorable outcomes in mechanical thrombectomy for high-risk pulmonary embolism and acute limb ischemia.
Safety Profile
Reported complications include potential risks associated with mechanical thrombectomy, such as vessel injury and distal embolization. However, the studies generally indicate a favorable safety profile for the device.
Evidence Limitations
Current evidence is limited by the lack of long-term follow-up data and the need for larger, multicenter trials to confirm findings. Further research is needed to explore the device's efficacy in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Penumbra Embolectomy Aspiration System?
The device is indicated for mechanical thrombectomy in cases of venous thromboembolism, large vessel occlusion stroke, and acute limb ischemia.
What outcomes have been reported in clinical studies?
Clinical studies report effective recanalization in large vessel occlusion strokes and positive outcomes in high-risk pulmonary embolism cases.
What complications have been reported?
Safety data indicate potential complications such as vessel injury and distal embolization, though the overall safety profile is favorable.
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.