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indigo r aspiration system lightning flash aspiration tubing indigo r aspiration system lightning bolt aspiration tubing
Penumbra
Summary: The Indigo R Aspiration System by Penumbra is a medical device used for mechanical thrombectomy in venous systems. It is primarily utilized by interventional radiologists and vascular specialists to remove thrombi in patients with conditions like pulmonary embolism.
FDA Clearance Information
Pathway
510K
Number
K252612 ↗
Decision Date
October 16, 2025
Product Code
QEW
Device Class
Class 2
Evidence
40 studies
The Indigo R Aspiration System received FDA clearance through the 510k pathway on October 16, 2025. It is manufactured by Penumbra and is classified as a Class 2 medical device.
What It Is
The Indigo R Aspiration System is a mechanical thrombectomy device designed to aspirate thrombi from the venous system. It consists of specialized aspiration tubing, including the Lightning Flash and Lightning Bolt variants, which facilitate the removal of clots. The system operates by creating a vacuum to extract thrombi, offering a minimally invasive alternative to surgical thrombectomy.
Clinical Applications
This device is commonly used in the treatment of conditions such as deep vein thrombosis (DVT) and pulmonary embolism (PE), particularly when rapid intervention is required. It is typically employed in hospital settings by interventional radiologists and vascular surgeons. The system is suitable for patients who are at high risk or have contraindications to systemic thrombolysis.
Indications for Use
The FDA indications for the Indigo R Aspiration System include mechanical thrombectomy for venous thromboembolic conditions. It is particularly indicated for patients with thrombi in the venous system, such as those experiencing acute pulmonary embolism or deep vein thrombosis.
Practical Considerations
The Indigo R Aspiration System is available in various sizes to accommodate different vessel diameters. It is compatible with standard catheterization techniques and requires careful handling to ensure effective thrombus removal. Clinicians should be familiar with the device's setup and operation to optimize outcomes.
Related Literature
The linked study reports a case of high-risk pulmonary embolism with floating right atrial thrombi, treated using the Penumbra Indigo Lightning System. The study highlights a multidisciplinary approach combining mechanical thrombectomy for both right atrial thrombi and iliofemoral DVT. Key findings suggest that catheter-directed therapies can be effective in managing complex thromboembolic conditions. However, the study is limited by its single-case design, which may not be generalizable.
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 used for?
It is used for mechanical thrombectomy in the venous system, particularly for conditions like deep vein thrombosis and pulmonary embolism.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for mechanical thrombectomy in venous thromboembolic conditions, such as pulmonary embolism and deep vein thrombosis.
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.