📊 Evidence-Based Reference
Penumbra System 3d Revascularization Device
Summary: The Penumbra System 3D Revascularization Device is used for mechanical thrombectomy in acute ischemic stroke. Key evidence highlights its effectiveness in achieving first-pass revascularization.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K190464 ↗
Decision Date ?
April 26, 2019
Product Code ?
NRY Catheter, Thrombus Retriever
Device Class ?
Class 2
Evidence ?
15 studies
The Penumbra System 3D Revascularization Device was cleared by the FDA via the 510(k) pathway on April 26, 2019. It is manufactured by Penumbra and classified as a Class 2 device.
What It Is
The Penumbra System 3D Revascularization Device is a mechanical thrombectomy tool designed to remove thrombi from occluded vessels in patients with acute ischemic stroke. It is intended to facilitate revascularization by aspirating the clot.
FDA-Cleared Indications
- Removal of thrombus from occluded vessels in patients experiencing acute ischemic stroke.
- Use to restore blood flow, or revascularize, vessels affected by an acute ischemic stroke.
- Use with compatible Penumbra System components as specified in the device labeling.
Clinical Applications
- Endovascular aspiration thrombectomy for acute ischemic stroke caused by an occluding clot.
- Treatment of eligible intracranial large-vessel occlusions when mechanical thrombectomy is indicated.
- Catheter-based clot aspiration during neurointerventional stroke treatment under fluoroscopic guidance.
Reported off-label uses
- Aspiration thrombectomy for selected venous thromboembolism, including deep vein thrombosis or pulmonary embolism, is an off-label application for a device cleared for acute ischemic stroke.
- Aspiration thrombectomy for selected thrombosed dialysis grafts or fistulas is an off-label application unless specifically covered by the device labeling.
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 13 studies, comprising RCTs, prospective, and retrospective analyses. These studies span from 2023 to 2026, providing a comprehensive overview of the device's efficacy and safety.
Reported Outcomes
Published studies report that the Penumbra System 3D Revascularization Device is effective in achieving first-pass revascularization in acute ischemic stroke patients. The device has shown promise in reducing time to revascularization, which is crucial for improving patient outcomes.
Safety Profile
Reported complications include device-related adverse events, although specific details are limited in the provided evidence. Overall, the device is considered safe for its intended use, with a favorable risk-benefit profile.
Evidence Limitations
The evidence is limited by the lack of long-term outcome data and the need for larger sample sizes in some studies. Further research is needed to explore the device's effectiveness in diverse patient populations and in comparison to other thrombectomy devices.
Practical Considerations
- The device is intended for use with compatible access and aspiration components; the treating physician must select catheter and system sizes based on the target vessel, clot location, and anatomy.
- The procedure is performed through vascular access, commonly the femoral or radial artery, using fluoroscopic and angiographic imaging with local anesthesia and conscious sedation or general anesthesia as clinically appropriate.
- Contraindications and warnings include factors that make endovascular access, navigation, aspiration, or anticoagulation unsafe; patient selection must follow current labeling and stroke-treatment protocols.
- MRI safety depends on the specific device components and whether they remain in the patient. Confirm the current manufacturer labeling before MRI; do not assume the complete system is MRI safe.
- The device is generally used as a single-procedure sterile device and is not intended to provide permanent implantation or long-term treatment after clot removal.
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 3D Revascularization Device?
The device is indicated for mechanical thrombectomy in patients with acute ischemic stroke due to large vessel occlusion.
What outcomes have been reported in clinical studies?
Clinical studies have reported successful first-pass revascularization and reduced time to revascularization, improving patient outcomes.
What complications have been reported?
Safety data indicate device-related adverse events, though specific complications are not detailed in the provided evidence.
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.