Jetstream G3 Se System Jetstream G3 Sf System Model PV31230 Jetstream G3 Se Catheter and Control Pod PVCN100 Pv Con
Pathway Medical Technologies
FDA Clearance Information
The Jetstream G3 SE/SF System was cleared by the FDA through the 510(k) pathway on June 11, 2010. It is manufactured by Pathway Medical Technologies and classified as a Class II device.
What It Is
FDA-Cleared Indications
- Removal of plaque from peripheral arteries during atherectomy procedures.
- Removal of thrombotic material from peripheral arteries using mechanical thrombectomy.
- Treatment of peripheral arterial lesions when debulking or removal of obstructive material is clinically indicated.
Clinical Applications
- Atherectomy of atherosclerotic lesions in peripheral arteries.
- Mechanical thrombectomy for thrombotic material in peripheral arteries.
- Endovascular treatment of obstructive peripheral arterial disease in the lower extremities.
- Use with fluoroscopic guidance and compatible guidewires during catheter-based peripheral vascular procedures.
Practical Considerations
- The system includes a Jetstream G3 SE or SF catheter and a control pod; the specific catheter model and size must match the target vessel and procedure.
- The catheter is used over a compatible guidewire and requires fluoroscopic imaging, aspiration, and careful advancement to reduce the risk of vessel injury or embolization.
- The FDA record identifies model PV31230 and control pod PVCON100; current availability, configurations, and instructions for use should be confirmed with the manufacturer.
- MRI safety depends on the exact device configuration and whether any component remains in or near the patient. Do not assume the system is MRI safe; review current labeling before MRI.
- Potential complications include perforation, dissection, distal embolization, thrombosis, bleeding, infection, contrast reaction, and the need for additional angioplasty, stenting, thrombolysis, or surgery.
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 SE/SF System used for?
The Jetstream G3 SE/SF System is used for atherectomy and mechanical thrombectomy to remove plaque and thrombus from peripheral arteries.
What specialties typically use this device?
Interventional cardiologists and vascular surgeons 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 in peripheral arteries to improve blood flow.