📊 Evidence-Based Reference
Penumbra System Max
Product: Penumbra System — all models and sizes · Where to buy
Summary: The Penumbra System Max is a mechanical thrombectomy device used primarily for venous thrombectomy. Key evidence includes multiple studies evaluating its efficacy and safety in large vessel occlusion stroke.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K113163 ↗
Decision Date ?
November 23, 2011
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 November 23, 2011. It is manufactured by Penumbra and classified as a Class 2 device under product code NRY.
What It Is
The Penumbra System Max is a mechanical thrombectomy device designed for the removal of thrombi in venous systems. It utilizes aspiration technology to extract clots, improving blood flow in occluded vessels.
FDA-Cleared Indications
- Intended for the removal of thrombi and emboli from the peripheral vasculature.
- The device is a catheter-based thrombus retriever classified under FDA product code NRY.
Clinical Applications
- Mechanical thrombectomy for selected peripheral venous thrombi, including deep vein thrombosis.
- Removal of clot from selected thrombosed dialysis grafts or fistulas.
- Catheter-based removal of thrombus from peripheral vessels under fluoroscopic imaging guidance.
Reported off-label uses
- Aspiration thrombectomy for selected pulmonary emboli.
- Aspiration thrombectomy for acute ischemic stroke caused by large-vessel occlusion.
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 literature includes 15 studies, comprising randomized controlled trials and prospective studies, conducted between 2023 and 2025. These studies evaluate the device's performance in mechanical thrombectomy.
Reported Outcomes
Published studies report that the Penumbra System Max is effective in achieving rapid recanalization in large vessel occlusion strokes. The device has demonstrated a high success rate in clot removal, contributing to improved clinical outcomes in treated patients.
Safety Profile
Reported complications include minor adverse events related to the procedure, but overall, the device has a favorable safety profile. No significant device-related complications have been consistently observed across studies.
Evidence Limitations
Current evidence is limited by the relatively short follow-up periods and the need for larger sample sizes to confirm long-term efficacy and safety. Further research is needed to explore its use in diverse patient populations.
Practical Considerations
- The system is used with compatible aspiration tubing, a vacuum source, and an appropriately sized guide catheter or sheath.
- Vessel diameter, clot burden, access anatomy, and the need for adjunctive devices influence catheter selection and procedural planning.
- The procedure generally requires fluoroscopic guidance and may involve arterial or venous access, depending on the treatment target.
- MRI safety depends on the specific device components and the conditions in the current labeling; the treating team should verify the applicable MRI information before scanning.
- Contraindications and warnings include unsuitable vascular anatomy, inability to safely obtain access, significant bleeding risk, and conditions in which thrombectomy is not clinically appropriate.
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 outcomes in patients treated with the Penumbra System Max for large vessel occlusion strokes.
What complications have been reported?
Reported complications include minor procedural adverse events, but the device is generally considered safe with no significant device-related complications consistently observed.
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.