đź“‹ FDA Reference

indigo r aspiration system lightning bolt aspiration tubing

Penumbra

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 510K
Decision Date February 13, 2023
Product Code QEW
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.

Clinical Applications

This device is commonly used in the treatment of conditions such as deep vein thrombosis (DVT) and pulmonary embolism (PE), particularly in high-risk cases where rapid intervention is necessary. It is typically employed in hospital settings by interventional radiologists, vascular surgeons, and cardiologists. The system is especially useful in patients who are not candidates for systemic thrombolysis or where such treatment has failed.

Indications for Use

The FDA has cleared this device for use in mechanical thrombectomy procedures within the venous system. It is indicated for patients with thrombotic conditions such as DVT and PE, where rapid clot removal is critical.

Practical Considerations

The Indigo R Aspiration System Lightning Bolt is compatible with standard catheter sizes used in thrombectomy procedures. Clinicians should be familiar with catheter-based techniques and ensure that the device is compatible with the patient's anatomy and the specific clinical scenario.

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.

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.

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