đź“‹ FDA Reference

jetstream navitus system jetstream g3 sf system jetstream g3 se system jetstream g3 l system

Pathway Medical Technologies

Summary: The Jetstream Navitus System is an atherectomy and thrombectomy device used to remove plaque and thrombus from arterial vessels. It is primarily used by interventional cardiologists and vascular surgeons.

FDA Clearance Information

Pathway 510K
Decision Date April 20, 2011
Product Code MCW
Device Class Class 2
Evidence 18 studies

The Jetstream Navitus System was cleared by the FDA via the 510k pathway on April 20, 2011. Manufactured by Pathway Medical Technologies, it is a Class 2 device.

What It Is

The Jetstream Navitus System is a rotational atherectomy device designed to remove atherosclerotic plaque and thrombus from peripheral arteries. It uses a catheter-based system with a rotating cutting tip to debulk and aspirate material from the vessel lumen. This device is particularly useful in treating peripheral artery disease (PAD) by restoring blood flow in occluded vessels.

Clinical Applications

Commonly used in interventional cardiology and vascular surgery, the Jetstream Navitus System is employed in procedures to treat peripheral artery disease, especially in the lower extremities. It is used in hospital catheterization labs and outpatient vascular centers. Patients with significant arterial blockages due to plaque or thrombus, who are at risk for limb ischemia, are typical candidates for this device.

Indications for Use

The FDA has cleared this device for use in removing plaque and thrombus from peripheral arterial vessels. It is indicated for patients with peripheral artery disease, where arterial blockages impede blood flow.

Practical Considerations

The Jetstream Navitus System comes in various sizes to accommodate different vessel diameters. It is compatible with standard guidewires and requires a power console for operation. Clinicians should be trained in atherectomy techniques to optimize outcomes and minimize complications.

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 System used for?

It is used for removing plaque and thrombus from peripheral arterial vessels to treat peripheral artery disease.

What specialties typically use this device?

Interventional cardiologists and vascular surgeons typically use this device.

What are the FDA-cleared indications?

It is indicated for removing plaque and thrombus in patients with peripheral artery disease to restore blood flow.

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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