đź“‹ FDA Reference

jetstream g2 system models pv20300 jetstream g2 catheter and control pod pvcn100 pv console

Pathway Medical Technologies

Summary: The Jetstream G2 System is a medical device used for mechanical thrombectomy and atherectomy. It is typically utilized by vascular surgeons and interventional radiologists to remove blockages in arteries.

FDA Clearance Information

Pathway 510K
Decision Date January 13, 2009
Product Code MCW
Device Class Class 2
Evidence 18 studies

The Jetstream G2 System received FDA clearance through the 510(k) pathway on January 13, 2009. It is manufactured by Pathway Medical Technologies and is classified as a Class 2 device.

What It Is

The Jetstream G2 System is a catheter-based device designed for the removal of thrombus and atheromatous plaque from arteries. It consists of a catheter and a control pod that work together to mechanically break down and aspirate blockages. This device is particularly useful in treating peripheral arterial disease by restoring blood flow in occluded vessels.

Clinical Applications

The Jetstream G2 System is commonly used in interventional procedures to treat peripheral arterial disease, particularly in the lower extremities. Vascular surgeons and interventional radiologists often employ this device in hospital catheterization labs or outpatient settings. It is suitable for patients with arterial blockages due to atherosclerosis or thrombosis.

Indications for Use

The FDA-cleared indications for the Jetstream G2 System include the removal of thrombus and atheromatous plaque in peripheral arteries. It is intended for patients with conditions such as peripheral arterial disease, where blood flow is compromised due to blockages.

Practical Considerations

The Jetstream G2 System comes in various catheter sizes to accommodate different vessel diameters. It is compatible with standard guidewires and requires a control pod for operation. Clinicians should be trained in atherectomy techniques to optimize device performance and patient outcomes.

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 G2 System used for?

The Jetstream G2 System is used for mechanical thrombectomy and atherectomy to remove blockages in peripheral arteries.

What specialties typically use this device?

Vascular surgeons and interventional radiologists typically use the Jetstream G2 System.

What are the FDA-cleared indications?

The device is indicated for the removal of thrombus and atheromatous plaque in peripheral arteries.

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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