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jetstream navitus l system

Pathway Medical Technologies

Summary: The Jetstream Navitus L System is a medical device used for atherectomy and mechanical thrombectomy in arterial settings. It is typically used by interventional cardiologists and vascular surgeons to remove plaque and thrombus from arteries.

FDA Clearance Information

Pathway 510K
Decision Date February 24, 2012
Product Code MCW
Device Class Class 2
Evidence 18 studies

The Jetstream Navitus L System was cleared via the FDA 510(k) pathway on February 24, 2012. Manufactured by Pathway Medical Technologies, it is classified as a Class II device under product code MCW.

What It Is

The Jetstream Navitus L System is an atherectomy and mechanical thrombectomy device designed to remove atherosclerotic plaque and thrombus from peripheral arteries. Utilizing a rotating cutting mechanism, it facilitates the revascularization of occluded vessels. The device is designed to be minimally invasive, allowing for precise removal of blockages while preserving healthy vessel tissue.

Clinical Applications

This device is commonly used in interventional cardiology and vascular surgery to treat peripheral artery disease (PAD). It is particularly useful in patients with significant arterial blockages that are not amenable to balloon angioplasty alone. The device is employed in hospital catheterization labs and specialized vascular centers, primarily for adult patients with symptomatic PAD.

Indications for Use

The FDA-cleared indications for the Jetstream Navitus L System include the removal of atherosclerotic plaque and thrombus in peripheral arteries. It is intended for patients with peripheral artery disease who require revascularization to restore blood flow.

Practical Considerations

The Jetstream Navitus L System is available in various sizes to accommodate different vessel diameters. It is compatible with standard catheterization lab equipment and requires specific training to operate effectively. Clinicians should be aware of the device's rotational mechanism and ensure proper technique to avoid vessel damage.

Linked Studies (18)

PubMed • 2025

Jetstream Atherectomy with Paclitaxel-Coated Balloons: 3-Year Outcomes of the Prospective Randomized JET-RANGER Study.

The International journal of angiology : official publication of the International College of Angiology, Inc

RCT View Source →
PubMed • 2025

Insights From the FDA's MAUDE Database Regarding the Real-World Safety of Jetstream Atherectomy for Peripheral Arterial Disease.

Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2024

JETWING technique: Combination therapy of JETSTREAMⓇ and aggressive wire recanalization in calcified atheroma and dilatation technique for eccentric heavy calcified plaques using WINGMAN for insertion of protection wire.

Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions

View Source →
PubMed • 2023

Jetstream Atherectomy with Paclitaxel-Coated Balloons: Two-Year Outcome of the Prospective Randomized JET-RANGER Study.

Vascular health and risk management

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2022

Jetstream Atherectomy Followed by Paclitaxel-Coated Balloons versus Balloon Angioplasty Followed by Paclitaxel-Coated Balloons: Twelve-Month Exploratory Results of the Prospective Randomized JET-RANGER Study.

Vascular health and risk management

RCT|prospective View Source →
PubMed • 2022

Jetstream Rotational Atherectomy and Drug Coated Balloon Angioplasty with In Stent Re-stenosis and Occlusions. A Two Centre Study.

European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery

View Source →
PubMed • 2021

JetStream Atherectomy for the Treatment of In-Stent Restenosis of the Femoropopliteal Segment: One-Year Results of the JET-ISR Study.

Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2021

Jetstream Atherectomy in Treating Femoropopliteal In-Stent Restenosis: Meta-Analysis of the JETSTREAM-ISR and JET-ISR Trials.

The Journal of invasive cardiology

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2020

Jetstream Atherectomy System for Treatment of Femoropopliteal Artery Disease: A Single Center Experience and Mid-term Outcomes.

Annals of vascular surgery

Other View Source →
PubMed • 2019

Jetstream Atherectomy System treatment of femoropopliteal arteries: Results of the post-market JET Registry.

Cardiovascular revascularization medicine : including molecular interventions

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2015

JETSTREAM Atherectomy: A Review of Technique, Tips, and Tricks in Treating the Femoropopliteal Lesions.

The International journal of angiology : official publication of the International College of Angiology, Inc

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2012

Successful management of lower extremity distal embolization following percutaneous atherectomy with the JetStream G3 device.

The Journal of invasive cardiology

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2009

Use and abuse of atherectomy: where should it be used?

Seminars in vascular surgery

RCT|prospective|retrospective|case Series|other View Source →
ClinicalTrials.gov

A Study to Collect Intravascular Ultrasound Images Before and After Treatment With the Jetstream System

View Source →
ClinicalTrials.gov

JetStream Atherectomy for the Treatment of In-stent Restenosis

View Source →
ClinicalTrials.gov

Jetstream in Treatment of Occlusive Atherosclerotic Lesions in the SFA and/or PPA

View Source →
ClinicalTrials.gov

The Jetstream (JET) Post-market Registry

View Source →
ClinicalTrials.gov

The Jetstream G3™ Calcium Study

View Source →

Frequently Asked Questions

What is the Jetstream Navitus L System used for?

It is used for atherectomy and mechanical thrombectomy to remove plaque and thrombus from peripheral arteries.

What specialties typically use this device?

Interventional cardiologists and vascular surgeons typically use this device.

What are the FDA-cleared indications?

The device is indicated for removing atherosclerotic plaque and thrombus in peripheral arteries, particularly in patients with peripheral artery disease.

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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