đź“‹ FDA Reference

jetstream workspace

Adac Laboratories

Summary: The Jetstream Workspace is a medical device used for atherectomy and mechanical thrombectomy in arterial settings. It is typically used by interventional cardiologists and vascular surgeons to treat patients with arterial blockages.

FDA Clearance Information

Pathway 510K
Decision Date November 3, 2004
Product Code KPS
Device Class Class 2
Evidence 18 studies

The Jetstream Workspace was cleared through the FDA 510k pathway on November 3, 2004. Manufactured by Adac Laboratories, it is classified as a Class 2 device under product code KPS.

What It Is

The Jetstream Workspace is an advanced atherectomy device designed to remove atherosclerotic plaque and thrombus from arterial vessels. It utilizes a mechanical cutting mechanism to safely and effectively clear blockages, improving blood flow. The device is typically used in minimally invasive procedures, providing a reliable option for treating peripheral artery disease.

Clinical Applications

Commonly used in interventional cardiology and vascular surgery, the Jetstream Workspace is employed in procedures to treat peripheral artery disease. It is effective in both hospital and outpatient settings, particularly for patients with significant arterial blockages that are not amenable to traditional angioplasty. The device is suitable for a wide range of patients, including those with complex or calcified lesions.

Indications for Use

The Jetstream Workspace is indicated for use in patients with arterial blockages due to plaque or thrombus. It is particularly useful for those with peripheral artery disease, helping to restore blood flow and alleviate symptoms such as claudication.

Practical Considerations

The device comes in various sizes to accommodate different vessel diameters and is compatible with standard guidewires and catheters. Clinicians should be trained in atherectomy techniques to ensure optimal 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 Jetstream Workspace used for?

The Jetstream Workspace is used for removing plaque and thrombus from arterial vessels, particularly in patients with peripheral artery disease.

What specialties typically use this device?

Interventional cardiologists and vascular surgeons commonly use this device in procedures to treat arterial blockages.

What are the FDA-cleared indications?

The device is cleared for use in atherectomy and mechanical thrombectomy procedures to treat arterial blockages caused by plaque and thrombus.

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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