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Indigo Aspiration System Cat RX Aspiration Catheter and Separator 4
Summary: The Indigo Aspiration System CAT RX by Penumbra is a mechanical thrombectomy device used primarily for thrombus removal in coronary interventions. Key evidence suggests its efficacy in reducing thrombus burden in acute coronary syndrome.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K220683 ↗
Decision Date ?
October 4, 2022
Product Code ?
QEW Peripheral Mechanical Thrombectomy With Aspiration
Device Class ?
Class 2
Evidence ?
40 studies
The Indigo Aspiration System CAT RX was cleared by the FDA via the 510(k) pathway on October 4, 2022. It is manufactured by Penumbra and classified as a Class 2 device.
What It Is
The Indigo Aspiration System CAT RX is a mechanical thrombectomy device designed for the removal of thrombi in coronary arteries. It operates through continuous aspiration to extract thrombus material, intended for use in percutaneous coronary interventions.
FDA-Cleared Indications
- Removal of thrombus from coronary arteries during percutaneous coronary intervention.
- Use with the Indigo Aspiration System for aspiration thrombectomy in the coronary vasculature.
Clinical Applications
- Aspiration thrombectomy during percutaneous coronary intervention.
- Removal of thrombus in a coronary artery when clot burden interferes with coronary blood flow or intervention.
- Treatment of thrombotic material in the coronary vasculature using catheter-directed aspiration and the Separator 4.
Reported off-label uses
- Use in selected peripheral arterial or venous thrombectomy procedures has been reported for aspiration-catheter systems, but this is outside the coronary indication for this specific CAT RX system and should not be assumed to be FDA-cleared.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
The available literature includes 9 studies, comprising randomized controlled trials, prospective and retrospective studies, and case series, conducted between 2021 and 2025. These studies evaluate the device's efficacy and safety in coronary thrombus extraction.
Reported Outcomes
Published studies report that the Indigo Aspiration System CAT RX effectively reduces thrombus burden in patients with acute coronary syndrome, potentially improving myocardial reperfusion. The CHEETAH study highlights its role in mitigating risks associated with distal embolization during percutaneous coronary interventions.
Safety Profile
Reported complications include device-related failures and adverse events as noted in the MAUDE database. Some studies indicate potential risks of distal embolization and microvascular obstruction, although sustained mechanical aspiration may reduce these risks.
Evidence Limitations
Current evidence is limited by the small number of large-scale randomized controlled trials. Further research is needed to establish long-term outcomes and to compare the device's efficacy with other thrombectomy methods.
Practical Considerations
- The CAT RX and Separator 4 must be used with the compatible Indigo aspiration system components and an appropriate guide catheter or vascular access setup.
- Device dimensions, working length, and vessel compatibility should be confirmed in the current manufacturer instructions for use before the procedure.
- The system is intended for catheter-based procedures and requires fluoroscopic imaging, arterial access, anticoagulation or antiplatelet management as clinically appropriate, and trained operators.
- MRI safety and conditional-use information should be checked in the current labeling; do not take the catheter, separator, tubing, or other attached components into the MRI environment unless specifically permitted.
- Potential complications include bleeding or hematoma at the access site, vessel injury, dissection or perforation, distal embolization, arrhythmia, contrast reaction, kidney injury, and procedural ischemic complications.
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 Aspiration System CAT RX?
The device is indicated for thrombus removal in coronary arteries, particularly in cases of high thrombus burden during percutaneous coronary interventions.
What outcomes have been reported in clinical studies?
Studies report effective thrombus reduction and improved myocardial reperfusion, with potential benefits in reducing distal embolization risks.
What complications have been reported?
Reported complications include device-related failures and risks of distal embolization, as noted in the MAUDE database and other 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.