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Penumbra System Reperfusion Catheter Jet 7
Product: Penumbra System — all models and sizes
Summary: The Penumbra System Reperfusion Catheter Jet 7 is a mechanical thrombectomy device used for venous applications. It is FDA 510k cleared and supported by studies focusing on its technical performance and comparative effectiveness.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K173761 ↗
Decision Date ?
August 17, 2018
Product Code ?
NRY Catheter, Thrombus Retriever
Device Class ?
Class 2
Evidence ?
15 studies
The Penumbra System Reperfusion Catheter Jet 7 was cleared through the FDA 510k pathway on August 17, 2018. It is manufactured by Penumbra and classified as a Class 2 device under product code NRY.
What It Is
The Penumbra System Reperfusion Catheter Jet 7 is a mechanical thrombectomy device designed to remove thrombi from the venous system. It operates by vacuum aspiration, providing rapid reperfusion in cases of large vessel occlusion.
FDA-Cleared Indications
- Removal of thrombus from the neurovasculature in patients experiencing ischemic stroke.
- Use with compatible Penumbra System components to provide aspiration for mechanical thrombectomy.
- The device is intended for use by trained physicians in appropriately selected patients with neurovascular thromboembolism.
Clinical Applications
- Aspiration thrombectomy for selected acute ischemic strokes caused by large-vessel occlusion.
- Endovascular removal of thrombus from the intracranial neurovasculature.
- Use as part of a mechanical thrombectomy procedure performed through catheter access, typically from the femoral or radial artery.
Reported off-label uses
- Use in selected peripheral venous thromboembolism procedures, including deep vein thrombosis or pulmonary embolism thrombectomy, has been reported for large-bore aspiration catheter systems but is outside the neurovascular labeling for this device.
- Use in dialysis-access thrombectomy has been reported for aspiration catheter systems but is not established as an FDA-cleared indication for Jet 7.
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 a technical comparison study and a clinical trial, with publication years ranging from 2020 to unknown. These studies provide insights into the device's performance and comparative effectiveness.
Reported Outcomes
Published studies report that the Penumbra System Reperfusion Catheter Jet 7 is effective in achieving rapid reperfusion in cases of large vessel occlusion. The device's performance is comparable to other commercial options in terms of functional outcomes.
Safety Profile
Reported complications include those typical of mechanical thrombectomy procedures, although specific adverse events are not detailed in the provided evidence. Further studies are needed to comprehensively assess safety.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of detailed safety data. Further research is needed to explore long-term outcomes and potential complications associated with the device.
Practical Considerations
- Jet 7 is a large-bore aspiration catheter and must be used with compatible guide catheters, aspiration tubing, and Penumbra System components according to the current instructions for use.
- Catheter size and compatibility with the access sheath, guide catheter, target vessel, and clot anatomy must be confirmed before the procedure.
- The procedure requires fluoroscopic or angiographic imaging and is generally performed with local anesthesia and conscious sedation or general anesthesia, depending on the patient and clinical setting.
- MRI safety depends on the complete device setup and whether any components remain in the patient; the current manufacturer labeling should be checked before MRI.
- Potential risks include vessel injury or perforation, dissection, bleeding, embolization, contrast reaction, infection, and complications related to arterial access. Contraindications and warnings are defined in the current FDA-cleared instructions for use.
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 Reperfusion Catheter Jet 7?
The device is indicated for use in mechanical thrombectomy procedures to treat venous thromboembolism and large vessel occlusion.
What outcomes have been reported in clinical studies?
Studies report effective reperfusion and comparable functional outcomes to other thrombectomy devices.
What complications have been reported?
Reported complications include those typical of thrombectomy procedures, but specific adverse events 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.