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Indigo Aspiration System Lightning Aspiration Tubing
Product: Indigo System — all models and sizes
Summary: The Indigo Aspiration System Lightning Aspiration Tubing by Penumbra is a device used for mechanical thrombectomy in venous applications. Key evidence highlights its use in complex thrombus cases, including pediatric and high-risk patients.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K200771 ↗
Decision Date ?
April 22, 2020
Product Code ?
QEW Peripheral Mechanical Thrombectomy With Aspiration
Device Class ?
Class 2
Evidence ?
40 studies
The Indigo Aspiration System Lightning Aspiration Tubing was cleared by the FDA through the 510(k) pathway on April 22, 2020. It is manufactured by Penumbra and classified as a Class 2 device under product code QEW.
What It Is
The Indigo Aspiration System Lightning Aspiration Tubing is designed for mechanical thrombectomy, specifically in venous applications. It operates by aspirating thrombi from the venous system, providing a minimally invasive option for thrombus removal.
FDA-Cleared Indications
- The system is indicated for the removal of thrombus from vessels in the peripheral vasculature.
- It is intended for use with compatible aspiration catheters and a vacuum source as part of a mechanical thrombectomy procedure.
- The specific cleared indication, vessel size, catheter compatibility, and patient population depend on the complete device labeling and the compatible Indigo system components.
Clinical Applications
- Catheter-based aspiration thrombectomy for selected peripheral venous thrombus.
- Aspiration thrombectomy for deep vein thrombosis when treatment is appropriate under the device labeling.
- Aspiration thrombectomy for selected pulmonary embolism cases when the complete compatible system is cleared for that use.
- Removal of thrombus from other labeled peripheral vessels using the compatible Indigo aspiration catheter and console.
Evidence Summary
The available literature includes 7 studies, comprising case reports and retrospective analyses, published between 2024 and 2025. These studies explore the device's application in various thrombotic conditions.
Reported Outcomes
Published studies report successful thrombus removal in high-risk pulmonary embolism and deep vein thrombosis cases. The device has been used effectively in both adult and pediatric populations, demonstrating versatility in complex clinical scenarios.
Safety Profile
Reported complications include potential risks associated with catheter-directed therapies, such as bleeding and vascular injury. However, the studies highlight the device's safety profile in managing challenging thrombotic cases.
Evidence Limitations
The evidence is limited by the small number of studies and the predominance of case reports, which may not fully capture the device's efficacy and safety across broader populations. Further research is needed to establish long-term outcomes and comparative effectiveness.
Practical Considerations
- This is tubing used with a compatible Indigo aspiration catheter, aspiration pump or console, and associated accessories; it is not a standalone thrombectomy catheter.
- Confirm the tubing, catheter, pump, and connector compatibility before the procedure and follow the current manufacturer instructions for use.
- Device selection depends on the target vessel, thrombus burden, access route, catheter size, and the anatomy being treated.
- The tubing is intended for single use and should not be resterilized or reused.
- MRI safety and conditional-use information should be checked in the current labeling for the complete system; do not assume that the tubing is safe for MRI solely because it is nonimplantable.
Procedures that use this device
Linked Studies (20)
PubMed • 2025
Randomized Controlled Trial of Mechanical Thrombectomy With Anticoagulation Versus Anticoagulation Alone for Acute Intermediate-High Risk Pulmonary Embolism: Primary Outcomes From the STORM-PE Trial.
Circulation
RCT|prospective View Source →PubMed • 2025
A New Technique for Mechanical Thrombectomy in Patients With Acute Pulmonary Embolism: A Case Series.
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
Case Series View Source →PubMed • 2025
Rescue catheter directed treatment for floating right atrial thrombi and deep vein thrombosis in patient with high-risk acute pulmonary embolism: a case report of multidisciplinary approach.
European heart journal. Case reports
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Percutaneous vacuum-assisted tumor thrombectomy using angiovac and penumbra lightning 12 aspiration systems.
Radiology case reports
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2024
Safety and efficacy of mechanical aspiration thrombectomy for patients with acute lower extremity ischemia.
Journal of vascular surgery
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2024
Neuro-tracking catheter technology for coronary thrombus extraction: Indigo CAT RX Continuous Aspiration System - first use in Poland.
Postepy w kardiologii interwencyjnej = Advances in interventional cardiology
View Source →PubMed • 2024
[Interventional therapy of pulmonary embolism - update].
Deutsche medizinische Wochenschrift (1946)
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2024
Super-Elderly Case of Acute Lower Limb Ischemia Treated with Indigo Aspiration System in Japan.
Annals of vascular diseases
Case Series View Source →PubMed • 2024
Procedure-Related Mortality in Aspiration Thrombectomy for Pulmonary Embolism: A MAUDE Database Analysis of the Inari FlowTriever and Penumbra Indigo Systems.
Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2024
Endovascular thrombectomy for cerebral venous sinus thrombosis using the Penumbra Indigo® Aspiration System.
Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2024
Use of the Indigo CAT RX aspiration system during percutaneous coronary intervention.
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
Other View Source →PubMed • 2024
Anesthetic Management for Aspiration Thrombectomy Using the Penumbra Indigo System in Pediatric Patients with Congenital Heart Disease.
Journal of cardiothoracic and vascular anesthesia
Other View Source →PubMed • 2024
Penumbra Indigo® system to safely remove intracardiac thrombus in a 7-month-old infant with severe immunodeficiency disorder.
Cardiology in the young
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2023
Case Report: Catheter-based mechanical thrombectomy using the Indigo aspiration system in a case of systemic-to-pulmonary shunt thrombosis.
Frontiers in pediatrics
Case Report View Source →PubMed • 2023
Mechanical Venous Thrombectomy Using Indigo Aspiration System: A Case Report.
Cureus
View Source →PubMed • 2023
Indigo® Aspiration System for thrombectomy in pulmonary embolism.
Future cardiology
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2023
Penumbra Indigo Percutaneous Aspiration Thrombectomy System in the treatment of Aortic Endograft Iliac Limb Occlusion: Results from an Italian Multicentre Registry.
European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2022
Aspiration Thrombectomy with the Indigo System for Acute Lower Limb Ischemia: Preliminary experience and analysis of parameters affecting the outcome.
Annals of vascular surgery
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2022
Complications and Failure Modes of the Penumbra Indigo CAT RX Aspiration System in Percutaneous Coronary Intervention: Insights From the MAUDE Database.
Cardiovascular revascularization medicine : including molecular interventions
View Source →PubMed • 2022
Technical success and short-term results from mechanical thrombectomy for lower extremity iliofemoral deep vein thrombosis using a computer aided mechanical aspiration thrombectomy device.
Journal of vascular surgery. Venous and lymphatic disorders
RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What are the clinical indications for Indigo Aspiration System Lightning Aspiration Tubing?
The device is indicated for mechanical thrombectomy in venous thrombotic conditions, such as deep vein thrombosis and pulmonary embolism.
What outcomes have been reported in clinical studies?
Studies have reported successful thrombus removal in complex cases, including high-risk pulmonary embolism and pediatric thrombotic conditions.
What complications have been reported?
Safety data from evidence indicate potential complications such as bleeding and vascular injury, common to catheter-directed therapies.
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.