Jetstream
Deldent
FDA Clearance Information
The Jetstream device was cleared by the FDA via the 510k pathway on February 19, 2002. It is manufactured by Deldent and classified as a Class 2 device.
What It Is
FDA-Cleared Indications
- Removal of atherosclerotic plaque from peripheral arteries during atherectomy procedures.
- Removal of thrombotic material from peripheral arteries during mechanical thrombectomy procedures.
Clinical Applications
- Atherectomy of peripheral arterial lesions.
- Mechanical thrombectomy of peripheral arterial thrombus.
- Treatment of femoropopliteal arterial disease when plaque removal is clinically indicated.
- Lesion preparation before balloon angioplasty or other endovascular treatment, when consistent with the device labeling.
Reported off-label uses
- Treatment of selected in-stent restenosis lesions in peripheral arteries.
- Use before a drug-coated balloon in selected femoropopliteal lesions.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
Reported Outcomes
Safety Profile
Evidence Limitations
Practical Considerations
- Use requires compatible vascular access, guidewire, catheter, and imaging equipment according to the specific device instructions for use.
- The device is intended for peripheral vascular use; vessel diameter, lesion characteristics, access route, and available device sizes must be checked before treatment.
- Potential complications include embolization, perforation, dissection, thrombosis, bleeding, distal ischemia, and the need for additional treatment.
- MRI safety depends on the specific Jetstream system and whether the device is implanted or remains in the body; consult the current labeling rather than assuming MRI compatibility.
- Contraindications and warnings should be reviewed in the current manufacturer instructions for use, particularly for severe calcification, unsuitable vessel size, inability to cross the lesion, or inadequate distal blood flow.
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 are the clinical indications for Jetstream?
Jetstream is indicated for use in atherectomy and mechanical thrombectomy procedures, particularly in treating femoropopliteal arterial disease.
What outcomes have been reported in clinical studies?
Studies report improved freedom from target lesion revascularization with Jetstream plus paclitaxel-coated balloons compared to angioplasty alone.
What complications have been reported?
Safety data indicate no amputations, but there were 5 deaths in the Jetstream plus PCB group in the JET-RANGER study.