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Medrad

Summary: The JetStream XC/SC is an atherectomy and mechanical thrombectomy device used by interventional cardiologists and radiologists to remove arterial plaque and thrombi. It's designed for treating peripheral arterial disease and in-stent restenosis.

FDA Clearance Information

Pathway 510K
Number K133023 ↗
Decision Date August 27, 2014
Product Code MCW
Device Class Class 2
Evidence 18 studies

The JetStream XC/SC received FDA clearance through the 510(k) pathway on August 27, 2014. Manufactured by Medrad, it is classified as a Class 2 medical device under product code MCW.

What It Is

The JetStream XC/SC is a rotational atherectomy device designed to remove plaque and thrombi from arterial vessels. It features a rotating cutting mechanism that debulks and aspirates material, improving blood flow. The device is particularly useful in treating peripheral arterial disease and in-stent restenosis, providing a minimally invasive option for revascularization.

Clinical Applications

Clinically, the JetStream XC/SC is used in interventional cardiology and radiology settings, particularly for patients with peripheral arterial disease. It is employed in procedures to clear blocked arteries, often in the legs, to restore adequate blood flow. The device is suitable for use in outpatient settings or specialized vascular centers, and it is typically utilized for adult patients with symptomatic arterial blockages.

Indications for Use

The JetStream XC/SC is indicated for use in patients with peripheral arterial disease, particularly for removing plaque and thrombi from arteries. It is also used to treat in-stent restenosis, where previously placed stents have become narrowed again.

Practical Considerations

The JetStream XC/SC comes in various sizes to accommodate different vessel diameters. It is compatible with standard guidewires and catheters used in vascular procedures. Clinicians should be trained in atherectomy techniques to optimize outcomes and minimize complications.

Related Literature

The linked study investigated the use of the JetStream device for treating in-stent restenosis. Although specific details and results are not provided, such studies typically focus on the device's efficacy in reducing restenosis rates and improving vessel patency. Limitations may include sample size 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 XC/SC used for?

The JetStream XC/SC is used for atherectomy and mechanical thrombectomy to remove arterial plaque and thrombi, especially in peripheral arterial disease and in-stent restenosis.

What specialties typically use this device?

Interventional cardiologists and radiologists typically use the JetStream XC/SC in vascular procedures.

What are the FDA-cleared indications?

The device is indicated for removing plaque and thrombi from arteries in patients with peripheral arterial disease and for treating 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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