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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 510K
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.

Clinical Applications

The Indigo Optima Laser System is commonly used in urology practices for patients with symptomatic BPH. It is particularly beneficial in outpatient settings due to its ability to be performed under local anesthesia. The device is suitable for patients who are not ideal candidates for more invasive surgical procedures.

Indications for Use

The FDA-cleared indications for the Indigo Optima Laser System include the treatment of benign prostatic hyperplasia (BPH), a condition characterized by an enlarged prostate that can obstruct urinary flow. The device is intended for use in patients experiencing urinary symptoms due to BPH.

Practical Considerations

The Indigo Optima Laser System is compatible with standard urological equipment and can be used with various fiberoptic tips depending on the procedure. Clinicians should be trained in laser safety and the specific techniques required for effective treatment.

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.

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