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Penumbra System Penumbra System Max
Summary: The Penumbra System MAX is a mechanical thrombectomy device used for venous thrombectomy. It is FDA-cleared and supported by 15 studies, highlighting its efficacy in large vessel occlusion stroke treatment.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K133317 ↗
Decision Date ?
May 13, 2014
Product Code ?
NRY Catheter, Thrombus Retriever
Device Class ?
Class 2
Evidence ?
15 studies
The Penumbra System MAX was cleared by the FDA through the 510(k) pathway on May 13, 2014. It is manufactured by Penumbra and classified as a Class 2 device.
What It Is
The Penumbra System MAX is a mechanical thrombectomy device designed for the removal of thrombi from the venous system. It utilizes aspiration technology to effectively clear blockages in large vessels, primarily used in neurovascular interventions.
FDA-Cleared Indications
- Removal of thrombus from blood vessels when used with compatible catheter and aspiration components described in the FDA-cleared system labeling.
Clinical Applications
- Endovascular removal of blood clots from large vessels when the selected system configuration is indicated.
- Catheter-based thrombectomy performed under fluoroscopic or other appropriate imaging guidance.
- Use in vascular procedures where aspiration is used to evacuate thrombus from the treated vessel.
Reported off-label uses
- Mechanical thrombectomy for acute ischemic stroke caused by large-vessel occlusion when the specific configuration or use is outside the applicable labeling.
- Removal of thrombus in deep veins, pulmonary arteries, or dialysis-access circuits when not covered by the device's specific cleared indication.
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 15 studies, comprising randomized controlled trials and prospective studies, conducted between 2023 and 2025. These studies evaluate the safety and efficacy of the Penumbra System MAX in mechanical thrombectomy.
Reported Outcomes
Published studies report that the Penumbra System MAX achieves rapid and effective recanalization in large vessel occlusion strokes. The device has demonstrated high success rates in clot removal, contributing to improved clinical outcomes in patients undergoing mechanical thrombectomy.
Safety Profile
Reported complications include device-related adverse events such as vessel perforation and distal embolization. However, the overall safety profile is considered acceptable, with complications being relatively infrequent in the studied populations.
Evidence Limitations
Current evidence is limited by the lack of long-term follow-up data and the need for larger sample sizes to confirm findings. Further research is required to explore the device's efficacy in diverse patient populations and in comparison to alternative thrombectomy devices.
Practical Considerations
- The device is used through an appropriately sized vascular access sheath or catheter, with compatibility determined by the system configuration and the target vessel.
- Treatment requires imaging guidance and careful control of aspiration, catheter position, and blood loss.
- Operators should review the current instructions for use for vessel-size limits, compatible components, contraindications, and warnings before treatment.
- MRI safety depends on the individual system components and whether any components remain in the patient; the current labeling should be checked before MRI.
- Potential complications include bleeding, vascular injury, vessel perforation or dissection, distal embolization, infection, contrast reaction, and incomplete clot removal.
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 MAX?
The Penumbra System MAX is indicated for mechanical thrombectomy in patients with acute ischemic stroke due to large vessel occlusions.
What outcomes have been reported in clinical studies?
Clinical studies have reported successful recanalization and improved patient outcomes in large vessel occlusion strokes treated with the Penumbra System MAX.
What complications have been reported?
Safety data from evidence indicate complications such as vessel perforation and distal embolization, though these are relatively infrequent.
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.