📊 Evidence-Based Reference

indigo system aspiration catheter 7 indigo aspiration system separator 7 lightning 7

Penumbra

Summary: The Indigo System Aspiration Catheter 7 by Penumbra is a mechanical thrombectomy device primarily used for venous thromboembolism. Key evidence highlights its effectiveness in treating pulmonary embolism with excellent outcomes reported in case series.

FDA Clearance Information

Pathway 510K
Decision Date February 9, 2021
Product Code QEW
Device Class Class 2
Evidence 40 studies

The Indigo System Aspiration Catheter 7 received FDA 510(k) clearance on February 9, 2021. Manufactured by Penumbra, it is classified as a Class 2 medical device.

What It Is

The Indigo System Aspiration Catheter 7 is a mechanical thrombectomy device designed for the removal of thrombi in the venous system. It utilizes aspiration technology to extract clots, primarily used in the treatment of pulmonary embolism.

Clinical Applications

Commonly used in the management of high-risk and intermediate-high-risk pulmonary embolisms, the device is applied in scenarios requiring rapid thrombus removal to prevent mortality and long-term complications.

Evidence Summary

The literature includes a variety of study types such as case series and systematic reviews, with approximately 6 studies published between 2022 and 2025.

Reported Outcomes

Published studies report excellent outcomes in the use of the Indigo System for mechanical thrombectomy in pulmonary embolism cases. A case series highlighted significant improvements in patient conditions post-procedure. Systematic reviews have compared its efficacy favorably against other thrombolysis methods.

Safety Profile

Reported complications include minimal adverse events, with studies generally indicating a favorable safety profile. However, specific safety data was not detailed in the provided evidence.

Evidence Limitations

Current evidence is limited by the lack of randomized controlled trials, with most data derived from case series and systematic reviews. Further research is needed to establish long-term outcomes and safety in diverse populations.

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 System Aspiration Catheter 7?

The device is indicated for mechanical thrombectomy in venous thromboembolism, particularly in cases of pulmonary embolism.

What outcomes have been reported in clinical studies?

Studies report excellent outcomes in thrombus removal and patient recovery, particularly in high-risk pulmonary embolism cases.

What complications have been reported?

Reported complications include minimal adverse events, with a generally favorable safety profile noted in studies.

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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