đź“‹ FDA Reference

jetstream cavity preparation system

Dove Systems

Summary: The Jetstream Cavity Preparation System is a medical device used for atherectomy and mechanical thrombectomy in arterial procedures. It is primarily used by interventional cardiologists and vascular surgeons to remove plaque and thrombus from blood vessels.

FDA Clearance Information

Pathway 510K
Decision Date March 7, 1996
Product Code KOJ
Device Class Class 2
Evidence 18 studies

The Jetstream Cavity Preparation System was cleared through the FDA 510(k) pathway on March 7, 1996. Manufactured by Dove Systems, it is classified as a Class 2 medical device.

What It Is

The Jetstream Cavity Preparation System is a specialized atherectomy device designed to remove atherosclerotic plaque and thrombus from arterial vessels. It operates by mechanically cutting and aspirating debris from the vessel, restoring blood flow. The system is equipped with a rotating cutting tip and aspiration capabilities, making it effective in treating complex lesions.

Clinical Applications

This device is commonly used in interventional cardiology and vascular surgery settings, particularly in procedures addressing peripheral artery disease (PAD) and coronary artery disease (CAD). It is suitable for patients with significant arterial blockages where traditional angioplasty may be insufficient. The system is often employed in hospital catheterization labs and specialized vascular centers.

Indications for Use

The FDA-cleared indications for the Jetstream Cavity Preparation System include the removal of plaque and thrombus from arterial vessels. It is intended for patients with peripheral or coronary artery disease who require mechanical intervention to restore blood flow.

Practical Considerations

The Jetstream system typically comes in various sizes to accommodate different vessel diameters. It is compatible with standard guidewires and catheters used in endovascular procedures. Clinicians should be trained in atherectomy techniques to maximize the device's effectiveness 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 Cavity Preparation System used for?

It is used for removing plaque and thrombus from arterial vessels to restore blood flow in patients with peripheral or coronary artery disease.

What specialties typically use this device?

Interventional cardiologists and vascular surgeons typically use this device in endovascular procedures.

What are the FDA-cleared indications?

The device is indicated for the removal of atherosclerotic plaque and thrombus from arterial vessels in patients with peripheral or coronary artery disease.

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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