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Indigo R Aspiration System Lightning Bolt Aspiration Tubing
Summary: The Indigo R Aspiration System Lightning Bolt Aspiration Tubing is a medical device used for mechanical thrombectomy in venous systems. It is typically used by interventional radiologists and vascular specialists to remove thrombi in patients with conditions like deep vein thrombosis and pulmonary embolism.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K242075 ↗
Decision Date ?
September 25, 2024
Product Code ?
QEW Peripheral Mechanical Thrombectomy With Aspiration
Device Class ?
Class 2
Evidence ?
40 studies
The device was cleared through the FDA 510(k) pathway on September 25, 2024. It is manufactured by Penumbra and classified as a Class 2 medical device under product code QEW.
What It Is
The Indigo R Aspiration System Lightning Bolt Aspiration Tubing is a component of a mechanical thrombectomy system designed to remove thrombi from the venous system. It works by providing a conduit for aspiration, allowing for the efficient removal of blood clots. This system is particularly useful in cases where rapid clot removal is necessary to restore blood flow and reduce the risk of complications.
FDA-Cleared Indications
- The system is intended for the removal of thrombus from vessels in the peripheral vasculature.
- It is used with compatible Indigo aspiration catheters and a vacuum source during mechanical thrombectomy procedures.
- The tubing is a system component and is not intended to be used independently of the compatible Indigo system.
Clinical Applications
- Aspiration thrombectomy for selected lower-extremity deep vein thrombosis.
- Aspiration thrombectomy for selected peripheral venous thrombi.
- Aspiration thrombectomy in selected dialysis graft or fistula thrombosis procedures when the complete system labeling and compatible components support its use.
- Catheter-based removal of thrombus when treatment is performed by appropriately trained clinicians using compatible Indigo system components.
Practical Considerations
- This is tubing within an aspiration thrombectomy system, not a standalone thrombectomy catheter; clinicians must confirm compatibility with the selected catheter, separator or other accessories, and aspiration pump or vacuum source.
- Use requires fluoroscopic or other appropriate image guidance, vascular access equipment, and clinicians trained in catheter-directed thrombectomy.
- The treating team should review the current manufacturer instructions for use for vessel-size limits, pressure or vacuum settings, setup, priming, handling, and disposable-component requirements.
- MRI safety and conditional-use information should be verified in the current device labeling; the system is used during an image-guided vascular procedure and should not be assumed to be MRI safe.
- Risks may include bleeding or hematoma at the access site, vessel injury, perforation, distal embolization, contrast reaction, infection, blood loss, and recurrent thrombosis. Patient-specific contraindications and anticoagulation or thrombolytic management should be assessed before treatment.
Related Literature
The linked study discusses a case where the Indigo Lightning System was used in a multidisciplinary approach to treat a patient with high-risk acute pulmonary embolism and associated thrombi. The study highlights the successful use of mechanical thrombectomy to remove both right atrial thrombi and iliofemoral deep vein thrombosis in a single session. While promising, the study is limited by its single-case nature and calls for further research to validate these findings.
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 Indigo R Aspiration System Lightning Bolt Aspiration Tubing 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 and vascular specialists typically use this device in hospital and specialized clinic settings.
What are the FDA-cleared indications?
The device is indicated for use in mechanically removing thrombi from the venous system in patients with 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.