Jetstream G3 System Model PV31300 Jetstream G3 Catheter and Control Pod PVCN100 Pv Console
Pathway Medical Technologies
FDA Clearance Information
The Jetstream G3 System was cleared through the FDA 510(k) pathway on September 3, 2009. It is manufactured by Pathway Medical Technologies and classified as a Class 2 device.
What It Is
FDA-Cleared Indications
- Treatment of peripheral arterial disease by removing atherosclerotic plaque from peripheral arteries.
- Removal of thrombus from peripheral arteries during endovascular treatment.
- Mechanical atherectomy and thrombectomy to help restore or improve blood flow in diseased peripheral vessels.
Clinical Applications
- Removing plaque from lower-extremity arteries in patients with peripheral arterial disease.
- Removing thrombus from peripheral arteries during an endovascular procedure.
- Treating obstructive arterial lesions that limit blood flow to the legs.
- Use during catheter-based peripheral vascular interventions performed by trained clinicians.
Practical Considerations
- The system includes a disposable catheter and control pod used with a dedicated console; the catheter size must match the target vessel and lesion.
- Procedures are performed with fluoroscopic imaging, typically through arterial access such as the common femoral artery; guidewire and access requirements depend on the specific catheter configuration.
- Use requires training in peripheral endovascular intervention, device operation, aspiration, and management of possible embolization or vessel injury.
- The FDA record identifies the device as a Class II peripheral atherectomy catheter. MRI safety should be confirmed in the current manufacturer labeling before scanning; do not assume the complete system is MRI safe.
- Contraindications, vessel-size limits, guidewire compatibility, and handling instructions should be verified in the current instructions for use. Potential complications include perforation, dissection, distal embolization, bleeding, thrombosis, and need for additional 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 the Jetstream G3 System used for?
The Jetstream G3 System is used for mechanical thrombectomy and atherectomy to remove blockages in arterial vessels, particularly in peripheral arterial disease.
What specialties typically use this device?
Interventional cardiologists and vascular surgeons typically use the Jetstream G3 System.
What are the FDA-cleared indications?
The device is indicated for the removal of thrombus and atherosclerotic plaque in patients with peripheral arterial disease.