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Indigo R Aspiration System Lightning Bolt Aspiration Tubing
Product: Indigo System — all models and sizes
Summary: The Indigo R Aspiration System Lightning Bolt is a device used for mechanical thrombectomy in venous systems. It is primarily used by interventional radiologists and vascular specialists to remove thrombi.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K223186 ↗
Decision Date ?
February 13, 2023
Product Code ?
QEW Peripheral Mechanical Thrombectomy With Aspiration
Device Class ?
Class 2
Evidence ?
40 studies
The Indigo R Aspiration System Lightning Bolt, manufactured by Penumbra, was cleared via the FDA 510(k) pathway on February 13, 2023. It is classified as a Class 2 device under product code QEW.
What It Is
The Indigo R Aspiration System Lightning Bolt is a medical device designed for the removal of thrombi in the venous system through aspiration. It works by using a catheter-based approach to mechanically extract clots, thereby restoring blood flow. This system is part of a broader category of catheter-directed therapies that offer a minimally invasive alternative to traditional surgical methods.
FDA-Cleared Indications
- Use for mechanical thrombectomy with aspiration in the peripheral vasculature, consistent with FDA product code QEW.
- Use to remove thrombus from the venous system during catheter-based thrombectomy procedures.
Clinical Applications
- Aspiration thrombectomy for selected patients with deep vein thrombosis.
- Aspiration thrombectomy for selected venous thrombotic occlusions.
- Removal of thrombus during catheter-based treatment of peripheral venous disease.
- Use in hospital-based mechanical thrombectomy procedures performed by trained physicians.
Practical Considerations
- The system is used through catheter-based vascular access under fluoroscopic or other appropriate imaging guidance.
- The treating physician must select compatible catheter sizes and components based on the device instructions for use, vessel size, clot burden and patient anatomy.
- Potential complications include bleeding, vascular injury, embolization, infection, contrast-related reactions and complications related to sedation or anesthesia.
- MRI safety and conditional use depend on the specific system components and labeling; verify the current manufacturer MRI information before scanning a patient with any retained component.
- Contraindications, warnings and handling requirements should be reviewed in the current Penumbra instructions for use. Treatment decisions should account for anticoagulation status, bleeding risk and alternative medical or surgical therapies.
Related Literature
The linked study describes a case where the Indigo Lightning System was used in a multidisciplinary approach to treat a high-risk pulmonary embolism with floating right atrial thrombi and iliofemoral DVT. The study highlights the device's effectiveness in a single-session treatment, offering a promising alternative to systemic thrombolysis. However, as a case report, its findings are limited in generalizability and call for further research to validate the approach.
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 is the Indigo R Aspiration System Lightning Bolt used for?
It is used for the mechanical removal of thrombi in the venous system, particularly in cases of deep vein thrombosis and pulmonary embolism.
What specialties typically use this device?
Interventional radiologists, vascular surgeons, and cardiologists commonly use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for mechanical thrombectomy in the venous system, specifically for conditions like deep vein thrombosis and pulmonary embolism.
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.