📊 Evidence-Based Reference
Penumbra System Pennumbra Reperfusion Catheter 054 Model PSC054 Penumbra Separator 054 Model PSS054
Product: Penumbra System — all models and sizes · Where to buy
Summary: The Penumbra System Reperfusion Catheter 054 is a device used for mechanical thrombectomy in venous applications. It is primarily used to restore blood flow in cases of acute ischemic stroke. Key evidence highlights its effectiveness in large vessel occlusion scenarios.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K090752 ↗
Decision Date ?
September 21, 2009
Product Code ?
NRY Catheter, Thrombus Retriever
Device Class ?
Class 2
Evidence ?
15 studies
The Penumbra System Reperfusion Catheter 054 was cleared by the FDA through the 510(k) pathway on September 21, 2009. It is manufactured by Penumbra and classified as a Class 2 device under product code NRY.
What It Is
The Penumbra System Reperfusion Catheter 054 is designed for mechanical thrombectomy procedures, specifically to remove thrombi from blood vessels in the brain. It is intended to restore cerebral blood flow in patients experiencing acute ischemic stroke.
FDA-Cleared Indications
- Removal of thrombus from blood vessels using the Penumbra System Reperfusion Catheter 054 and Separator 054.
- Use in patients who require mechanical thrombus removal to restore or improve blood flow.
Clinical Applications
- Catheter-based mechanical thrombectomy for thrombus in appropriately sized blood vessels.
- Aspiration thrombectomy using the reperfusion catheter with the compatible separator.
- Endovascular removal of acute intravascular clot when restoration of blood flow is clinically indicated.
Reported off-label uses
- Use in selected venous thrombectomy procedures, such as treatment of deep vein thrombosis, may be reported in clinical practice but should not be assumed to be within the device's FDA-cleared labeling.
- Use in pulmonary embolism or thrombosed dialysis access may occur by physician judgment and institutional protocol, but these applications may be outside the original clearance.
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 10 studies, comprising randomized controlled trials, prospective, and retrospective analyses. These studies span from 2020 to 2025, providing a comprehensive overview of the device's clinical performance.
Reported Outcomes
Published studies report that the Penumbra System Reperfusion Catheter 054 is effective in achieving rapid and complete recanalization in large vessel occlusion strokes. The device has been shown to be comparable to other thrombectomy systems in terms of efficacy, with some studies indicating non-inferiority to combined alteplase and thrombectomy treatments.
Safety Profile
Reported complications include device-related vascular injury and hemorrhagic transformation, which are consistent with known risks of mechanical thrombectomy procedures. However, the overall safety profile is considered acceptable within the context of acute ischemic stroke treatment.
Evidence Limitations
The evidence is limited by the relatively small sample sizes in some studies and the lack of long-term follow-up data. Further research is needed to explore the device's performance in diverse patient populations and to establish standardized protocols for its use.
Practical Considerations
- The system includes a 0.054-inch reperfusion catheter and a compatible 0.054-inch separator; vascular access and delivery requirements depend on the target vessel and procedure.
- Use requires appropriate catheter access, imaging guidance, aspiration equipment and operator experience with endovascular thrombectomy.
- The device should be checked for compatibility with the guidewire, sheath, aspiration system and other equipment before use.
- Potential complications include bleeding, vessel injury, perforation, dissection, embolization, infection and contrast-related reactions.
- MRI safety depends on the exact device configuration and whether any components remain in the patient; review the current manufacturer labeling before MRI.
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 Reperfusion Catheter 054?
The device is indicated for use in mechanical thrombectomy procedures to restore blood flow in patients with acute ischemic stroke due to large vessel occlusion.
What outcomes have been reported in clinical studies?
Studies have reported effective recanalization rates and comparable efficacy to other thrombectomy systems, with some trials showing non-inferiority to combined alteplase and thrombectomy treatments.
What complications have been reported?
Safety data from evidence indicate complications such as vascular injury and hemorrhagic transformation, which are typical risks associated with mechanical thrombectomy.
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.