Jetstream G3 L System Pv Console Models PV31400 PV31300 PVCN100
Pathway Medical Technologies
FDA Clearance Information
The Jetstream G3 L System was cleared through the FDA 510k pathway on May 19, 2010. Manufactured by Pathway Medical Technologies, 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 blockages using a catheter-based atherectomy or thrombectomy procedure.
Clinical Applications
- Atherectomy of peripheral arterial plaque in patients with peripheral artery disease.
- Mechanical thrombectomy to remove thrombus from peripheral arteries.
- Endovascular treatment of lower-extremity arterial lesions that restrict blood flow.
- Plaque or thrombus removal during a peripheral vascular intervention performed by a trained clinician.
Practical Considerations
- The system includes console models PV31400, PV31300, and PVCN100 and is used with compatible Jetstream catheter components; the catheter size and configuration must match the target vessel and lesion.
- The device is operated over a compatible guidewire under fluoroscopic imaging, with aspiration used to evacuate plaque and thrombotic material.
- Use requires clinicians trained in peripheral atherectomy, thrombectomy, guidewire technique, and management of potential complications such as embolization, perforation, dissection, or vessel injury.
- The FDA record identifies the device as a Class II peripheral atherectomy catheter system under product code MCW; labeling and the specific device instructions should be reviewed before use.
- MRI safety depends on the specific catheter and console components. The device should not be assumed to be MR safe or MR conditional unless the current manufacturer labeling confirms the conditions.
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 the Jetstream G3 L System used for?
The Jetstream G3 L System is used for removing plaque and thrombus from peripheral arteries, particularly in patients with peripheral artery disease.
What specialties typically use this device?
Vascular surgeons and interventional radiologists typically use this device in procedures to treat peripheral artery disease.
What are the FDA-cleared indications?
The device is indicated for the removal of atherosclerotic plaque and thrombus from peripheral arteries to improve blood flow.