Indigo Diffuser-Tip Fiberoptic with Temperature Sensing Option Model LF001
Ethicon Endo-Surgery
FDA Clearance Information
The Indigo Diffuser-Tip Fiberoptic was cleared via the FDA 510(k) pathway on March 16, 2001. Manufactured by Ethicon Endo-Surgery, it is classified as a Class 2 device.
What It Is
FDA-Cleared Indications
- Removal of thrombi from the venous system.
- Use during catheter-based mechanical thrombectomy for venous thrombus removal.
Clinical Applications
- Catheter-based removal of thrombus from a vein.
- Mechanical thrombectomy for selected patients with venous thromboembolism.
- Mechanical treatment of venous obstruction caused by thrombus when a treating physician determines catheter intervention is appropriate.
Practical Considerations
- The device is available in configurations or sizes intended for different vessel and catheter-system requirements; clinicians should confirm compatibility before use.
- The temperature-sensing option may provide intraprocedural temperature information, but it does not replace standard imaging, procedural monitoring or clinical judgment.
- Use requires fluoroscopic or other appropriate imaging guidance and operators trained in venous thrombectomy techniques.
- The FDA record supplied does not establish MRI safety. MRI compatibility should be confirmed from the current device labeling before scanning a patient with the device in place.
- Contraindications, warnings, access requirements and handling instructions should be taken from the current manufacturer labeling; treatment decisions should account for bleeding risk, venous anatomy and the cause of the thrombus.
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 Indigo Diffuser-Tip Fiberoptic used for?
It is used for mechanical thrombectomy in venous systems to remove thrombi and restore blood flow.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
It is indicated for the removal of thrombi in venous conditions such as deep vein thrombosis.