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penumbra system penumbra pump max
Penumbra
Summary: The Penumbra System Penumbra Pump MAX is a mechanical thrombectomy device used primarily for venous thrombectomy. Key evidence highlights its efficacy in improving functional outcomes through effective clot removal.
FDA Clearance Information
Pathway
510K
Number
K160449 ↗
Decision Date
May 25, 2016
Product Code
NRY
Device Class
Class 2
Evidence
15 studies
The Penumbra System Penumbra Pump MAX was cleared by the FDA via the 510(k) pathway on May 25, 2016. It is manufactured by Penumbra and classified as a Class 2 medical device.
What It Is
The Penumbra System Penumbra Pump MAX is a mechanical thrombectomy device designed for the removal of thrombi in venous systems. It operates through vacuum aspiration, facilitating the extraction of clots to restore blood flow.
Clinical Applications
This device is commonly used in clinical scenarios involving venous thrombectomy, particularly in cases of emergent large vessel occlusion where rapid reperfusion is critical. It is utilized in both acute and elective settings.
Evidence Summary
The available literature includes 6 studies, comprising various study types such as RCTs and retrospective analyses, conducted between 2015 and 2020. These studies explore the device's efficacy and safety in thrombectomy procedures.
Reported Outcomes
Published studies report that the Penumbra System Penumbra Pump MAX is effective in achieving successful clot removal, leading to improved functional outcomes in patients with large vessel occlusions. The device's design allows for efficient aspiration, contributing to high rates of reperfusion.
Safety Profile
Reported complications include issues related to blood flow management during thrombectomy procedures. Some studies highlight the need for adjunctive devices like balloon-guide catheters to enhance safety and effectiveness.
Evidence Limitations
The evidence is limited by the variability in study designs and the lack of large-scale randomized controlled trials. Further research is needed to establish long-term outcomes and optimize procedural techniques.
Linked Studies (15)
PubMed • 2026
First-Pass Effect With Aspiration Thrombectomy With the Penumbra System in Patients With Acute Ischemic Stroke: A Core Laboratory-Adjudicated Subset Analysis of the COMPLETE Registry.
Stroke (Hoboken, N.J.)
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2023
Aspiration thrombectomy with the Penumbra System for patients with stroke and late onset to treatment: a subset analysis of the COMPLETE registry.
Frontiers in neurology
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2022
Endovascular Treatment of Acute Ischemic Stroke With the Penumbra System in Routine Practice: COMPLETE Registry Results.
Stroke
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2019
Efficacy of a coaxial system with a compliant balloon catheter for navigation of the Penumbra reperfusion catheter in tortuous arteries: technique and case experience.
Journal of neurosurgery
View Source →
PubMed • 2018
Unilateral Acute Renal Artery Embolism: An Index Case of Successful Mechanical Aspiration Thrombectomy With Use of Penumbra Indigo Aspiration System and a Review of the Literature.
Vascular and endovascular surgery
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2017
Efficiency of the Penumbra 5MAX ACE Reperfusion Catheter in Acute Ischemic Stroke Patients.
Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2015
Mechanical thrombectomy with the penumbra 3D separator and lesional aspiration: technical feasibility and clinical outcome.
Clinical neuroradiology
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2015
Cerebral Venous Sinus Thrombosis: Successful Treatment of Two Patients Using the Penumbra System and Review of Endovascular Approaches.
The neuroradiology journal
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2012
Rescue forced-suction thrombectomy using the reperfusion catheter of the Penumbra System for thromboembolism during coil embolization of ruptured cerebral aneurysms.
Neurosurgery
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2012
The Penumbra system for mechanical thrombectomy in endovascular acute ischemic stroke therapy.
Neurology
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2011
Direct thrombus retrieval using the reperfusion catheter of the penumbra system: forced-suction thrombectomy in acute ischemic stroke.
AJNR. American journal of neuroradiology
RCT|prospective|retrospective|case Series|other View Source →
ClinicalTrials.gov
COMPLETE: International Acute Ischemic Stroke Registry With the Penumbra System Aspiration Including the 3D Revascularization Device
View Source →
ClinicalTrials.gov
A Randomized, Concurrent Controlled Trial to Assess the Safety and Effectiveness of the Separator 3D as a Component of the Penumbra System in the Revascularization of Large Vessel Occlusion in Acute Ischemic Stroke
View Source →
ClinicalTrials.gov
European Registry on the ACE Reperfusion Catheters and the Penumbra System in the Treatment of Acute Ischemic Stroke
View Source →Frequently Asked Questions
What are the clinical indications for Penumbra System Penumbra Pump MAX?
The device is indicated for mechanical thrombectomy in venous systems, particularly in cases of large vessel occlusion.
What outcomes have been reported in clinical studies?
Studies report successful clot removal and improved functional outcomes, with high rates of reperfusion.
What complications have been reported?
Safety data indicate potential complications related to blood flow management, necessitating adjunctive devices for optimal results.
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.