Indigo Medical Model Idl 830e
Indigo Medical
FDA Clearance Information
The Indigo Medical Model IDL 830e was cleared through the FDA 510(k) pathway on February 16, 1996. It is manufactured by Indigo Medical and is classified as a Class 2 device under product code GEX.
What It Is
FDA-Cleared Indications
- Removal of thrombi from the venous system.
Clinical Applications
- Image-guided mechanical removal of venous thrombi.
- Treatment procedures for venous thrombosis when clot removal is clinically indicated.
- Endovascular venous thrombectomy performed through catheter-based vascular access.
Practical Considerations
- The device should be used by clinicians trained in catheter-based thrombectomy and venous interventions.
- Vessel size, clot location, thrombus burden and access anatomy must be evaluated before treatment; available device dimensions should be confirmed in the applicable labeling.
- Imaging guidance is used for positioning and to assess clot removal and venous flow.
- Potential complications include bleeding, vessel injury, embolization, incomplete clot removal and recurrent thrombosis.
- MRI safety should not be assumed from the 510(k) record alone. Confirm the current device labeling and institutional MRI safety information before scanning a patient with any retained component.
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 Medical Model IDL 830e used for?
It is used for the mechanical removal of thrombi from venous systems, particularly in cases of deep vein thrombosis.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for the removal of thrombi from venous systems to restore blood flow in conditions like deep vein thrombosis.