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Indigo Optima Laser System Optima Diffuser-Tip Fiberoptic-Bph Optima Bare-Tip Fiberoptic Optima Laser Cart with Prints
Ethicon Endo-Surgery
Summary: The Indigo Optima Laser System is a medical device used primarily for the treatment of benign prostatic hyperplasia (BPH). It is utilized by urologists to perform laser coagulation and vaporization procedures.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K023182 ↗
Decision Date ?
October 24, 2002
Product Code ?
GEX
Device Class ?
Class 2
Evidence ?
40 studies
The Indigo Optima Laser System was cleared through the FDA 510(k) pathway on October 24, 2002. It is manufactured by Ethicon Endo-Surgery and classified as a Class 2 device under product code GEX.
What It Is
The Indigo Optima Laser System is a laser-based medical device designed for the treatment of benign prostatic hyperplasia (BPH). It utilizes laser energy to either vaporize or coagulate prostatic tissue, thereby alleviating urinary obstruction. The system includes a diffuser-tip fiberoptic for interstitial laser coagulation and a bare-tip fiberoptic for direct tissue interaction.
FDA-Cleared Indications
- Treatment of symptomatic benign prostatic hyperplasia (BPH).
- Laser coagulation of prostate tissue using the diffuser-tip fiberoptic.
- Laser vaporization or direct laser treatment of prostate tissue using the bare-tip fiberoptic.
Clinical Applications
- Interstitial laser coagulation of enlarged prostate tissue for urinary obstruction caused by BPH.
- Laser vaporization of prostate tissue in patients with symptomatic BPH.
- Endoscopic urologic treatment of prostate enlargement using the system's compatible optical fibers.
- Treatment of lower urinary tract symptoms attributable to benign prostatic enlargement.
Practical Considerations
- The system includes a diffuser-tip fiberoptic for interstitial coagulation and a bare-tip fiberoptic for direct tissue interaction or vaporization.
- Use requires appropriate urologic equipment, laser-safety precautions, and clinician training in the selected laser technique.
- The available FDA record does not establish MRI safety; the system and fibers should be kept out of the MRI environment unless current manufacturer labeling specifically permits use.
- Patient selection should account for prostate anatomy, urinary obstruction, bleeding risk, infection, anesthesia needs, and whether medication or surgical treatment would be more appropriate.
- The laser cart, print materials, console, and fiberoptic components should be checked for compatibility and damage before use; single-use fiber components should not be reused unless their labeling specifically permits it.
Related Literature
The linked study, titled 'The evolution of laser therapy in the treatment of benign prostatic hyperplasia,' examines the principles of laser therapy for BPH, focusing on vaporization and coagulation techniques. It highlights the Indigo Optima Laser System as a widely used interstitial laser coagulation (ILC) system, noting its efficacy under local anesthesia. However, the study does not provide comparative data against other laser systems.
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 is the Indigo Optima Laser System used for?
The Indigo Optima Laser System is used for the treatment of benign prostatic hyperplasia (BPH) to alleviate urinary obstruction.
What specialties typically use this device?
Urologists primarily use this device in the treatment of BPH.
What are the FDA-cleared indications?
The device is indicated for the treatment of benign prostatic hyperplasia (BPH), particularly in patients experiencing urinary symptoms due to prostate enlargement.
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.