Indigo R Lightning Flash Aspiration System Select Catheter
Product: Indigo System — all models and sizes
FDA Clearance Information
The Indigo R Lightning Flash Aspiration System, manufactured by Penumbra, was cleared through the FDA 510(k) pathway on June 10, 2024. It is classified as a Class 2 device under product code QEW.
What It Is
FDA-Cleared Indications
- Removal of thrombi from the venous system using aspiration thrombectomy.
- Treatment of patients with venous blood clots when mechanical clot removal is clinically indicated.
Clinical Applications
- Aspiration thrombectomy for selected cases of deep vein thrombosis.
- Removal of thrombus from large peripheral veins to help restore venous blood flow.
- Catheter-based treatment of venous thromboembolism in an interventional radiology or vascular surgery setting.
- Use with fluoroscopic and other vascular imaging guidance during venous thrombectomy procedures.
Practical Considerations
- The catheter is introduced through vascular access, commonly in the femoral or other suitable peripheral vein, and advanced under fluoroscopic guidance.
- Available catheter configurations and sizes should be matched to the target vessel, clot burden and access anatomy according to the current device instructions for use.
- The system is intended for use with compatible aspiration equipment and standard endovascular techniques; procedural imaging is required for positioning and treatment assessment.
- MRI safety and conditions depend on the complete device system and the current manufacturer labeling. Confirm MR status before scanning; do not assume the catheter is MR safe or MR conditional after implantation.
- Contraindications, warnings and handling requirements should be reviewed in the current FDA-cleared instructions for use. Potential concerns include unsuitable vascular anatomy, inability to obtain safe access and bleeding risk from anticoagulation or the procedure.
Procedures that use this device
Linked Studies (20)
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 →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 →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 →Percutaneous vacuum-assisted tumor thrombectomy using angiovac and penumbra lightning 12 aspiration systems.
Radiology case reports
RCT|prospective|retrospective|case Series|other View Source →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 →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 →[Interventional therapy of pulmonary embolism - update].
Deutsche medizinische Wochenschrift (1946)
RCT|prospective|retrospective|case Series|other View Source →Super-Elderly Case of Acute Lower Limb Ischemia Treated with Indigo Aspiration System in Japan.
Annals of vascular diseases
Case Series View Source →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 →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 →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 →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 →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 →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 →Mechanical Venous Thrombectomy Using Indigo Aspiration System: A Case Report.
Cureus
View Source →Indigo® Aspiration System for thrombectomy in pulmonary embolism.
Future cardiology
RCT|prospective|retrospective|case Series|other View Source →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 →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 →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 →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 Lightning Flash Aspiration System used for?
It is used for the mechanical removal of blood clots from the venous system, particularly in cases of deep vein thrombosis.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in clinical settings.
What are the FDA-cleared indications?
The device is indicated for the removal of thrombi in the venous system, especially for conditions like deep vein thrombosis.