📊 Evidence-Based Reference
Penumbra System Reperfusion Catheter Jet 7
Summary: The Penumbra System Reperfusion Catheter Jet 7 is a device used for mechanical thrombectomy in venous applications. It is FDA 510k cleared and supported by studies highlighting its role in improving reperfusion outcomes.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K190010 ↗
Decision Date ?
June 16, 2019
Product Code ?
NRY Catheter, Thrombus Retriever
Device Class ?
Class 2
Evidence ?
15 studies
The Penumbra System Reperfusion Catheter Jet 7 was cleared by the FDA through the 510k pathway on June 16, 2019. It is manufactured by Penumbra and classified as a Class 2 device.
What It Is
The Penumbra System Reperfusion Catheter Jet 7 is a mechanical thrombectomy device designed for venous applications. It utilizes vacuum aspiration to remove thrombi, facilitating reperfusion in cases of large vessel occlusion.
FDA-Cleared Indications
- Used for the removal of thrombus during endovascular treatment when catheter-based thrombus retrieval is indicated.
- The FDA product code identifies this device category as a catheter for thrombus retrieval under 21 CFR 870.1250.
- Use is limited to the patient populations, vascular territories, accessory devices, and procedural conditions specified in the current FDA-cleared labeling.
Clinical Applications
- Catheter-based aspiration thrombectomy for selected acute venous thromboembolism.
- Removal of thrombus from selected deep veins in patients undergoing DVT thrombectomy.
- Removal of thrombus from selected pulmonary arteries during pulmonary embolism thrombectomy.
- Removal of thrombus from selected dialysis grafts or fistulas during dialysis-access thrombectomy.
Reported off-label uses
- Use in vascular territories or clinical situations not specifically included in the current FDA-cleared labeling may occur in practice, but this is off-label and should be determined by the treating physician.
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 two studies: a technical comparison study published in 2020 and an ongoing clinical trial. These studies provide insights into the device's efficacy and safety, though specific outcomes are not detailed.
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. However, detailed efficacy outcomes are not specified in the provided evidence.
Safety Profile
Reported complications include general risks associated with mechanical thrombectomy, though specific adverse events are not detailed in the provided studies.
Evidence Limitations
The evidence is limited by the lack of detailed outcomes and safety data. Further research is needed to establish comprehensive efficacy and safety profiles, as well as long-term outcomes.
Practical Considerations
- Jet 7 is a large-bore aspiration catheter; the treating team must confirm compatibility with the guide catheter, sheath, aspiration pump or tubing, and the target vessel.
- The catheter is advanced over a guidewire under fluoroscopic imaging, generally through percutaneous venous access for venous thrombectomy.
- Device size, length, access route, clot burden, vessel diameter, and tortuosity affect whether the catheter can be used safely.
- MRI safety and conditions depend on the specific catheter configuration and labeling; do not assume MRI compatibility without checking the current instructions for use.
- Potential complications include bleeding at the access site, vessel injury, distal embolization, contrast-related complications, infection, and cardiopulmonary complications related to the underlying thrombosis.
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 Penumbra System Reperfusion Catheter Jet 7?
The device is indicated for mechanical thrombectomy in cases of venous thromboembolism, particularly in emergent large vessel occlusion scenarios.
What outcomes have been reported in clinical studies?
The studies highlight the device's role in achieving rapid reperfusion, though specific outcome metrics are not detailed.
What complications have been reported?
Safety data from the studies do not specify particular complications, but general risks associated with mechanical thrombectomy are implied.
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.