Jetstream G3 R Sf 1 6 System
Pathway Medical Technologies
FDA Clearance Information
The Jetstream G3 R SF 1.6 System was cleared through the FDA 510(k) pathway on June 1, 2011. 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.
Clinical Applications
- Endovascular treatment of peripheral arterial lesions containing atherosclerotic plaque.
- Mechanical removal of thrombus in peripheral arteries.
- Atherectomy during treatment of symptomatic peripheral artery disease.
- Plaque or thrombus removal as part of a catheter-based procedure intended to improve peripheral arterial blood flow.
Practical Considerations
- The system uses a rotating cutting mechanism with aspiration; operators should select the device based on vessel diameter, lesion characteristics and the intended treatment segment.
- It is used with guidewire and catheter techniques typical of peripheral endovascular intervention; compatibility should be confirmed in the current instructions for use.
- Potential complications include vessel injury, perforation, dissection, distal embolization, thrombosis, bleeding and the need for additional treatment.
- MRI safety depends on the specific components and whether they remain in the patient; the current device labeling should be checked before MRI.
- Use is generally avoided or requires special assessment when the target vessel, lesion or patient condition falls outside the device labeling or creates an unacceptable risk of vascular injury.
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 R SF 1.6 System used for?
The Jetstream G3 R SF 1.6 System is used for mechanical thrombectomy and atherectomy to remove plaque and thrombus from peripheral arteries.
What specialties typically use this device?
Interventional cardiologists and vascular surgeons typically use this device in endovascular procedures.
What are the FDA-cleared indications?
The device is indicated for the removal of atherosclerotic plaque and thrombus in peripheral arteries to treat peripheral artery disease.