📊 Evidence-Based Reference
Penumbra System Penumbra Pump Max
Product: Penumbra System — all models and sizes · Where to buy
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 ?
510(k)
Number ?
K160449 ↗
Decision Date ?
May 25, 2016
Product Code ?
NRY Catheter, Thrombus Retriever
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.
FDA-Cleared Indications
- Use with compatible Penumbra System catheters for the removal of thrombus from blood vessels.
- Intended for use by trained physicians when mechanical removal of intravascular thrombus is clinically appropriate.
- The FDA product code identifies this device category as a catheter-based thrombus retriever.
Clinical Applications
- Aspiration-assisted mechanical thrombectomy for selected venous thrombi.
- Removal of thrombus during treatment of deep vein thrombosis when a compatible cleared catheter system is used.
- Thrombectomy of selected thrombosed dialysis grafts or fistulas with compatible access-thrombectomy equipment.
- Catheter-based thrombus removal in other labeled vascular applications specified by the compatible Penumbra System catheter instructions for use.
Reported off-label uses
- Aspiration thrombectomy for selected pulmonary emboli has been reported in clinical practice with compatible catheter systems, but the specific indication depends on the catheter's labeling and should not be inferred from the pump clearance alone.
- Use in selected arterial thrombectomy procedures has been described for some compatible aspiration systems; clinicians must verify the labeling of the complete system before use.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
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.
Practical Considerations
- The pump must be used with compatible tubing, canisters, catheters and accessories identified in the applicable instructions for use; it is not used independently.
- Catheter diameter, working length and access-site requirements vary by the connected Penumbra System catheter and the target vessel.
- The system requires careful priming, vacuum management and monitoring for blood loss, air entry, catheter obstruction and loss of aspiration.
- MRI safety depends on the individual catheter, tubing and accessories. The pump is external, but connected components should be checked for their specific MR labeling before scanning.
- Contraindications and warnings are determined by the complete system labeling and may include unsuitable vessel anatomy, inability to obtain safe vascular access, bleeding risk or other factors that make thrombectomy inappropriate.
Procedures that use this device
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.