Jetstream G3 L System Model PV31400 Jetstream G3 L Catheter with Control Pod PVCN100 Pv Console
Pathway Medical Technologies
FDA Clearance Information
The Jetstream G3 L System, manufactured by Pathway Medical Technologies, received FDA clearance via the 510(k) pathway on January 21, 2010. It is classified as a Class 2 device under product code MCW.
What It Is
FDA-Cleared Indications
- Removal of atherosclerotic plaque from peripheral arteries.
- Removal of thrombus from peripheral arteries.
- Treatment of peripheral arterial obstruction when atherectomy or thrombectomy is clinically appropriate.
Clinical Applications
- Atherectomy of plaque in peripheral lower-extremity arteries.
- Mechanical thrombectomy of thrombus in peripheral arteries.
- Lesion preparation before balloon angioplasty or other endovascular treatment when plaque removal is indicated.
- Treatment of peripheral arterial disease with obstructive plaque or thrombus in a catheter-based procedure.
Practical Considerations
- The system includes a disposable catheter with a control pod and a console; the console supplies power and controls catheter operation.
- Catheter size and working length must match the target vessel, lesion characteristics, access route and compatible guidewire requirements.
- The procedure requires fluoroscopic or other intravascular imaging guidance and an operator trained in peripheral atherectomy and thrombectomy.
- The device is intended for peripheral arterial use and should not be assumed to be suitable for coronary, carotid, intracranial or venous applications unless current labeling specifically permits them.
- MRI safety depends on the specific catheter and system components; confirm the current manufacturer labeling before an MRI examination. The device is not left in the body after treatment.
Linked Studies (18)
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 →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 →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 →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 →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 →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 →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 →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 →Jetstream Atherectomy System for Treatment of Femoropopliteal Artery Disease: A Single Center Experience and Mid-term Outcomes.
Annals of vascular surgery
Other View Source →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 →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 →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 →Use and abuse of atherectomy: where should it be used?
Seminars in vascular surgery
RCT|prospective|retrospective|case Series|other View Source →A Study to Collect Intravascular Ultrasound Images Before and After Treatment With the Jetstream System
View Source →Jetstream in Treatment of Occlusive Atherosclerotic Lesions in the SFA and/or PPA
View Source →Frequently Asked Questions
What is Jetstream G3 L System used for?
It is used for atherectomy and mechanical thrombectomy in peripheral arteries to remove plaque and thrombus.
What specialties typically use this device?
Interventional cardiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for the removal of atherosclerotic plaque and thrombus in peripheral arteries to restore blood flow.