đź“Š Evidence-Based Reference
Indigo R Aspiration System Aspiration Catheter 6x
Summary: The Indigo R Aspiration System Aspiration Catheter 6X is a mechanical thrombectomy device used primarily for venous thromboembolism. Key evidence includes studies on its use in high-risk pulmonary embolism and deep vein thrombosis.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K242319 ↗
Decision Date ?
September 3, 2024
Product Code ?
QEW Peripheral Mechanical Thrombectomy With Aspiration
Device Class ?
Class 2
Evidence ?
40 studies
The device was cleared by the FDA through the 510(k) pathway on September 3, 2024. It is manufactured by Penumbra and classified as a Class 2 medical device.
What It Is
The Indigo R Aspiration System Aspiration Catheter 6X is designed for mechanical thrombectomy, facilitating the removal of thrombi in venous systems. It is intended for use in patients with conditions such as pulmonary embolism and deep vein thrombosis.
FDA-Cleared Indications
- Removal of thrombus from the peripheral vasculature.
- Use with the compatible Indigo Aspiration System and accessories as described in the device labeling.
Clinical Applications
- Aspiration thrombectomy for selected peripheral venous thrombi.
- Catheter-based treatment of deep vein thrombosis when peripheral venous thrombectomy is clinically appropriate.
- Aspiration thrombectomy for selected thrombotic occlusion of dialysis grafts or fistulas.
- Removal of thrombus from other labeled peripheral vascular locations according to the catheter's instructions for use.
Reported off-label uses
- Aspiration thrombectomy for pulmonary embolism has been described in clinical practice for Indigo-system devices, but the exact indication should be confirmed in the current device labeling and institutional protocol.
- Use in right-heart or right-atrial thrombus is reported in clinical practice but may be off-label depending on the specific catheter, anatomy, and labeling.
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 literature includes two studies, both published in 2025, comprising randomized controlled trials and case series. These studies explore the device's efficacy and safety in mechanical thrombectomy.
Reported Outcomes
Published studies report that the Indigo R Aspiration System Aspiration Catheter 6X shows promise in managing high-risk pulmonary embolism and deep vein thrombosis. The device has been evaluated in both prospective and retrospective settings, demonstrating its potential efficacy over anticoagulation alone.
Safety Profile
Reported complications include those typically associated with endovascular procedures, although specific adverse events were not detailed in the provided studies. Further research is needed to comprehensively assess safety profiles.
Evidence Limitations
The evidence is limited by the small number of studies and lack of detailed safety outcomes. Further research is needed to establish long-term efficacy and safety, as well as to explore its use in broader patient populations.
Practical Considerations
- The 6X catheter is a large-bore aspiration catheter; access, sheath size, guidewire requirements, and compatibility must be confirmed in the current instructions for use.
- Procedures generally require fluoroscopic or other appropriate imaging guidance, vascular access, anticoagulation planning, and monitoring for bleeding or vessel injury.
- Potential contraindications include inability to safely obtain vascular access, vessel anatomy that cannot accommodate the catheter, and contraindications to anticoagulation or the required procedure; the treating team should review the labeling.
- MRI safety and conditional scanning requirements depend on the catheter and any retained or associated components. The device should not be considered MRI safe unless the current manufacturer labeling specifically permits the planned scan.
- The catheter is intended for single use and is not designed to remain implanted after thrombectomy.
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 are the clinical indications for Indigo R Aspiration System Aspiration Catheter 6X?
The device is indicated for mechanical thrombectomy in venous thromboembolism, including high-risk pulmonary embolism and deep vein thrombosis.
What outcomes have been reported in clinical studies?
Studies report potential efficacy in managing high-risk pulmonary embolism and deep vein thrombosis, with the device showing promise over anticoagulation alone.
What complications have been reported?
Reported complications include those common to endovascular procedures, though specific adverse events were not detailed in the studies provided.
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.