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indigo optima laser system

Ethicon Endo-Surgery

Summary: The Indigo Optima Laser System is a medical device used primarily for laser therapy in conditions like benign prostatic hyperplasia (BPH). It is utilized by urologists and other specialists in settings that require minimally invasive procedures.

FDA Clearance Information

Pathway 510K
Decision Date December 13, 2001
Product Code GEX
Device Class Class 2
Evidence 40 studies

The Indigo Optima Laser System was cleared through the FDA 510(k) pathway on December 13, 2001. Manufactured by Ethicon Endo-Surgery, it is 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 to deliver precise thermal energy for tissue treatment. It operates by using laser technology to either vaporize or coagulate tissue, depending on the clinical need. This system is particularly known for its use in interstitial laser coagulation, which allows for effective treatment with minimal invasiveness.

Clinical Applications

The device is commonly used in urology, particularly for the treatment of benign prostatic hyperplasia (BPH). It is suitable for outpatient settings and can be performed under local anesthesia, making it accessible for a wide range of patients. The system is also applicable in other specialties where precise tissue ablation or coagulation is required.

Indications for Use

The Indigo Optima Laser System is indicated for use in patients with conditions like benign prostatic hyperplasia. It is designed to reduce symptoms by removing or reducing obstructive tissue in a minimally invasive manner.

Practical Considerations

The system is compatible with standard laser fibers and requires careful handling to ensure precise application. Clinicians should be trained in laser safety and the specific techniques required for effective use of the device.

Related Literature

The linked study discusses the evolution of laser therapy in treating benign prostatic hyperplasia, highlighting the Indigo Optima Laser System as a widely used interstitial laser coagulation (ILC) system. It emphasizes the system's ability to perform procedures under local anesthesia, offering a less invasive alternative to traditional methods. Limitations include the need for specialized training and equipment.

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 Indigo Optima Laser System used for?

It is used for laser therapy in conditions like benign prostatic hyperplasia, providing minimally invasive treatment options.

What specialties typically use this device?

Urologists and other specialists in minimally invasive surgical settings commonly use this device.

What are the FDA-cleared indications?

The device is indicated for treating benign prostatic hyperplasia and other conditions requiring tissue vaporization or coagulation.

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.

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