Jetstream G2 Nxt System Model PV20300
Pathway Medical Technologies
FDA Clearance Information
The Jetstream G2 NXT System, manufactured by Pathway Medical Technologies, was cleared by the FDA via the 510(k) pathway on June 19, 2009. It is classified as a Class 2 medical device.
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 mechanical debulking is indicated.
Clinical Applications
- Endovascular debulking of plaque in peripheral arteries affected by peripheral artery disease.
- Mechanical removal of thrombus from peripheral arterial lesions.
- Treatment of obstructive lesions in lower-extremity arteries, including femoral and popliteal vessels, when consistent with the device labeling.
- Use with catheter-based peripheral revascularization procedures to prepare or open an obstructed arterial segment.
Practical Considerations
- The system includes catheter sizes intended for use in different peripheral vessel diameters; the operator selects the appropriate size based on vessel anatomy and the device instructions for use.
- The catheter is advanced over a compatible guidewire under fluoroscopic imaging and requires operator training in rotational atherectomy and aspiration techniques.
- Access is typically obtained through a peripheral artery, commonly the common femoral artery, although the access site depends on the treatment plan and anatomy.
- MRI safety should be determined from the current manufacturer labeling. The device should not be assumed to be MRI safe while implanted or retained; confirm that no device component remains before MRI.
- Risks include vessel injury, perforation, dissection, distal embolization, thrombosis, bleeding at the access site, infection and the possibility that additional angioplasty, stenting or surgery will be needed.
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 G2 NXT System used for?
The Jetstream G2 NXT System is used for removing atherosclerotic plaque and thrombus from peripheral arteries to restore blood flow.
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 in patients with peripheral artery disease.