📊 Evidence-Based Reference
Penumbra System
Product: Penumbra System — all models and sizes · Where to buy
Summary: The Penumbra System is a mechanical thrombectomy device primarily used for the treatment of acute ischemic stroke. Key evidence highlights its efficacy in aspiration thrombectomy for large vessel occlusion.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K072718 ↗
Decision Date ?
December 28, 2007
Product Code ?
NRY Catheter, Thrombus Retriever
Device Class ?
Class 2
Evidence ?
15 studies
The Penumbra System was cleared by the FDA via the 510(k) pathway on December 28, 2007. It is manufactured by Penumbra and classified as a Class 2 device.
What It Is
The Penumbra System is a mechanical thrombectomy device designed for the removal of thrombi in patients with acute ischemic stroke. It utilizes aspiration to restore blood flow in occluded vessels.
FDA-Cleared Indications
- Removal of thrombus from the peripheral vasculature in patients with peripheral vascular disease.
- Use as a catheter-based thrombus-retrieval device under the specific indications and labeling of the cleared system component.
Clinical Applications
- Mechanical thrombectomy for selected peripheral venous thrombi.
- Removal of clot from selected peripheral arterial occlusions.
- Catheter-based thrombectomy in procedures involving appropriately sized peripheral vessels.
Reported off-label uses
- Aspiration thrombectomy for acute ischemic stroke involving large-vessel occlusion, when performed with a device and indication not specifically cleared for that use.
- Aspiration thrombectomy for pulmonary embolism.
- Thrombectomy of dialysis graft or fistula occlusions.
- Treatment of selected other venous thromboembolic occlusions in specialized clinical practice.
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 various study types such as RCTs and registries, conducted between 2020 and 2025. These studies evaluate the safety and efficacy of the Penumbra System.
Reported Outcomes
Published studies report that the Penumbra System is effective in achieving reperfusion in patients with acute ischemic stroke due to large vessel occlusion. The COMPLETE registry highlights its performance in real-world settings, demonstrating successful outcomes in late-onset treatment scenarios.
Safety Profile
Reported complications include device-related adverse events, although specific safety data from the studies is limited. The RESCUE-ICAS registry notes concerns regarding the safety of adjunct procedures like emergent stenting.
Evidence Limitations
The evidence is limited by the variability in study designs and the lack of long-term outcome data. Further research is needed to assess the safety and efficacy of the Penumbra System in diverse patient populations.
Practical Considerations
- The Penumbra System is a product family; catheter, separator, tubing, and aspiration-pump specifications vary by generation and model.
- Vessel diameter, clot location, access route, and compatibility with guide catheters or sheaths must be confirmed from the current device labeling.
- Typical access is through a percutaneous femoral or other appropriate arterial or venous access site, with fluoroscopic guidance.
- MRI safety depends on the exact components and whether any device remains in the patient; consult the current labeling before MRI.
- Contraindications and warnings include inability to safely access the target vessel, unsuitable vessel anatomy, active bleeding risk, and conditions in which anticoagulation or thrombolytic therapy is contraindicated or 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 the Penumbra System?
The Penumbra System is indicated for mechanical thrombectomy in patients with acute ischemic stroke due to large vessel occlusion.
What outcomes have been reported in clinical studies?
Studies report effective reperfusion and positive outcomes in real-world settings, particularly for late-onset treatment.
What complications have been reported?
Safety data indicate potential device-related adverse events, with concerns about adjunct procedures like emergent stenting.
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.