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jetstream xc 2 4 3 4 system jetstream xc 2 1 3 0 system jetstream sc 1 85 system jetstream sc 1 6 system

Medrad

Summary: The Jetstream XC/SC systems are atherectomy devices used for removing plaque and thrombus in peripheral arteries. They are primarily used by interventional cardiologists and vascular surgeons.

FDA Clearance Information

Pathway 510K
Number K130637 ↗
Decision Date April 10, 2013
Product Code MCW
Device Class Class 2
Evidence 18 studies

The Jetstream XC/SC systems, manufactured by Medrad, received FDA clearance through the 510k pathway on April 10, 2013. They are classified as Class 2 devices under product code MCW.

What It Is

The Jetstream XC/SC systems are mechanical atherectomy devices designed to remove atherosclerotic plaque and thrombus from peripheral arteries. Utilizing a rotating cutting mechanism, these devices help restore blood flow by debulking arterial blockages. They are particularly useful in treating complex lesions, including those with calcified plaque.

Clinical Applications

These devices are commonly used in endovascular procedures to treat peripheral artery disease (PAD). Interventional cardiologists and vascular surgeons use them in settings such as catheterization labs or operating rooms. They are suitable for patients with symptomatic PAD, especially those with in-stent restenosis or heavily calcified lesions.

Indications for Use

The Jetstream systems are indicated for use in patients with peripheral arterial disease to remove plaque and thrombus, improving blood flow. They are particularly beneficial for patients with in-stent restenosis or complex arterial blockages.

Practical Considerations

The Jetstream devices come in various sizes to accommodate different vessel diameters. They are compatible with standard guidewires and require careful handling to ensure optimal performance and minimize vessel trauma. Operators should be trained in atherectomy techniques.

Related Literature

The linked study investigated the use of Jetstream atherectomy for treating in-stent restenosis. Although the abstract is not available, such studies typically assess the device's efficacy in reducing restenosis rates and improving vessel patency. Limitations may include small sample sizes and lack of long-term follow-up data.

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 Jetstream used for?

Jetstream is used for removing plaque and thrombus in peripheral arteries to improve blood flow.

What specialties typically use this device?

Interventional cardiologists and vascular surgeons typically use the Jetstream systems.

What are the FDA-cleared indications?

The device is indicated for the removal of atherosclerotic plaque and thrombus in peripheral arteries, particularly in cases of in-stent restenosis.

Related Device Categories

Atherectomy Devices Mechanical Thrombectomy Arterial
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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