Jetstream Xc 2 4 3 4 System Jetstream Xc 2 1 3 0 System Jetstream Sc 1 85 System Jetstream Sc 1 6 System
Medrad
FDA Clearance Information
The Jetstream XC/SC systems, manufactured by Medrad, received FDA clearance through the 510k pathway on April 10, 2013. They are classified as Class 2 devices 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 disease using catheter-based atherectomy.
Clinical Applications
- Debulking plaque in peripheral arterial lesions before or during endovascular treatment.
- Removing thrombotic material from peripheral arteries.
- Treating symptomatic peripheral arterial disease in appropriately selected patients.
- Treating complex peripheral arterial blockages, including calcified lesions, when the device is suitable for the vessel size and anatomy.
Practical Considerations
- The systems are available in different catheter configurations and sizes for selected peripheral vessel diameters; the operator must choose the appropriate model for the target anatomy.
- The device is used over a compatible guidewire under fluoroscopic imaging, typically through vascular access in the common femoral artery or another suitable peripheral access site.
- Atherectomy requires trained operators because possible complications include vessel dissection, perforation, distal embolization, thrombosis, and bleeding at the access site.
- The FDA record identifies the device as a Class II peripheral atherectomy catheter under product code MCW. MRI compatibility should be confirmed in the current manufacturer labeling for the exact system; do not assume it is MRI safe after use.
- Contraindications, warnings, vessel-size limits, guidewire requirements, and treatment restrictions should be checked in the current instructions for use before each procedure.
Related Literature
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 used for?
Jetstream is used for removing plaque and thrombus in peripheral arteries to improve blood flow.
What specialties typically use this device?
Interventional cardiologists and vascular surgeons typically use the Jetstream systems.
What are the FDA-cleared indications?
The device is indicated for the removal of atherosclerotic plaque and thrombus in peripheral arteries, particularly in cases of in-stent restenosis.