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Penumbra System Penumbra Jet 7x
Product: Penumbra System — all models and sizes · Where to buy
Summary: The Penumbra System Penumbra Jet 7X is a mechanical thrombectomy device used to remove clots from veins. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K191946 ↗
Decision Date ?
February 27, 2020
Product Code ?
NRY Catheter, Thrombus Retriever
Device Class ?
Class 2
Evidence ?
15 studies
The Penumbra System Penumbra Jet 7X was cleared through the FDA 510(k) pathway on February 27, 2020. Manufactured by Penumbra, it is classified as a Class 2 device under product code NRY.
What It Is
The Penumbra System Penumbra Jet 7X is a mechanical thrombectomy device designed to remove thrombi from the venous system. It operates by using aspiration to extract clots, which can help restore blood flow in affected vessels. This device is part of a broader category of endovascular tools that aim to treat vascular blockages without the need for open surgery.
FDA-Cleared Indications
- Removal of thrombus from the venous system.
- Treatment of venous thrombotic obstruction when mechanical clot removal is indicated.
Clinical Applications
- Mechanical thrombectomy for selected deep vein thrombosis.
- Endovascular removal of thrombus from large veins.
- Thrombectomy of selected venous occlusions when aspiration-based clot removal is appropriate.
Reported off-label uses
- Use in pulmonary embolism thrombectomy may depend on the specific FDA labeling, catheter model, and procedural configuration; clinicians should verify current labeling before use.
- Use in dialysis graft or fistula thrombectomy may be off-label unless specifically covered by the applicable 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.
Practical Considerations
- The catheter must be matched to the target vessel, clot burden, access system, and other devices used during the procedure.
- The procedure is performed under fluoroscopic imaging through vascular access, commonly from the femoral or jugular vein, with local anesthesia and moderate sedation or general anesthesia depending on the patient and procedure.
- Potential complications include bleeding at the access site, vessel injury, infection, clot migration or embolization, contrast reaction, and recurrent thrombosis.
- MRI safety should be confirmed in the current manufacturer’s instructions for use; do not assume that a catheter or retained component is MRI safe or MRI conditional.
- The device is intended for single use and is not designed to remain permanently in the body; procedure duration and hospital stay depend on the treated condition and the patient's clinical status.
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 is the Penumbra System Penumbra Jet 7X used for?
It is used for the mechanical removal of blood clots from the venous system to restore blood flow.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for the removal of thrombi from the venous system in patients with thrombotic conditions.
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.