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jetstream pathway pc atherectomy system model ov10300

Pathway Medical Technologies

Summary: The Jetstream Pathway PC Atherectomy System is a medical device used for atherectomy and mechanical thrombectomy in arterial settings. It is primarily used by interventional cardiologists and vascular surgeons to treat peripheral arterial disease.

FDA Clearance Information

Pathway 510K
Number K083489 ↗
Decision Date January 23, 2009
Product Code MCW
Device Class Class 2
Evidence 18 studies

The Jetstream Pathway PC Atherectomy System received FDA clearance via the 510k pathway on January 23, 2009. It is manufactured by Pathway Medical Technologies and is classified as a Class 2 device under product code MCW.

What It Is

The Jetstream Pathway PC Atherectomy System is an advanced medical device designed to remove atherosclerotic plaque and thrombus from peripheral arteries. It operates using a rotating cutting mechanism that safely debulks and aspirates occlusive material. This device is particularly useful in restoring blood flow in patients with peripheral arterial disease (PAD), offering a minimally invasive alternative to more extensive surgical procedures.

Clinical Applications

This device is commonly used in interventional cardiology and vascular surgery settings, particularly for patients with peripheral arterial disease. It is utilized in procedures aimed at revascularizing occluded arteries in the lower extremities, often in outpatient catheterization labs or hospital-based interventional suites. The typical patient population includes those with symptomatic PAD, such as claudication or critical limb ischemia.

Indications for Use

The FDA-cleared indications for the Jetstream Pathway PC Atherectomy System include the treatment of peripheral arterial disease by removing plaque and thrombus from arterial vessels. It is intended for use in patients with occlusive vascular disease to improve blood flow and alleviate symptoms.

Practical Considerations

The device is available in various sizes to accommodate different vessel diameters and is compatible with standard guidewires and catheters. Clinicians should be trained in atherectomy techniques and consider vessel anatomy and lesion characteristics when selecting the appropriate device size and approach.

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 Pathway PC Atherectomy System used for?

It is used for removing plaque and thrombus from peripheral arteries to treat peripheral arterial disease.

What specialties typically use this device?

Interventional cardiologists and vascular surgeons typically use this device in procedures aimed at revascularizing occluded arteries.

What are the FDA-cleared indications?

The device is indicated for the treatment of peripheral arterial disease by removing plaque and thrombus to improve blood flow.

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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