Jetstream Xc 2 4 3 4 Jetstream Xc 2 1 3 0 Jetstream Sc 1 85 Jetstream Sc 1 6
Medrad
FDA Clearance Information
The JetStream XC/SC received FDA clearance through the 510(k) pathway on August 27, 2014. Manufactured by Medrad, it is classified as a Class 2 medical device under product code MCW.
What It Is
FDA-Cleared Indications
- Removal of plaque from peripheral arteries in patients with peripheral arterial disease.
- Removal of thrombotic material from peripheral arteries.
- Treatment of stenosis or occlusion, including in-stent restenosis, in peripheral arteries.
Clinical Applications
- Rotational atherectomy to debulk atherosclerotic plaque in peripheral arteries.
- Mechanical removal and aspiration of thrombotic material during peripheral endovascular revascularization.
- Treatment of peripheral arterial stenosis or occlusion affecting blood flow, commonly in the lower-extremity arteries.
- Treatment of selected peripheral in-stent restenosis cases.
Reported off-label uses
- Use in some complex peripheral lesions or vessel territories outside the device's specific cleared labeling may be reported in clinical practice, but these applications require case-by-case physician judgment and are not established by this FDA clearance.
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.
Practical Considerations
- The record includes JetStream XC 2.4/3.4, JetStream XC 2.1/3.0, JetStream SC 1.85, and JetStream SC 1.6 configurations; the appropriate catheter depends on the target-vessel diameter and lesion characteristics.
- The device is used over a compatible guidewire with fluoroscopic imaging and requires an atherectomy console, aspiration, and trained endovascular operators.
- Access is usually obtained through a peripheral artery, commonly the common femoral artery, although another access site may be selected based on anatomy and treatment location.
- Patients with severe vascular tortuosity, vessel perforation, dissection, or anatomy that does not accommodate the selected catheter may not be appropriate candidates.
- MRI safety depends on the specific device components and whether they remain in the patient; the temporary catheter and associated equipment should be managed according to the current manufacturer labeling and institutional MRI policy.
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 XC/SC used for?
The JetStream XC/SC is used for atherectomy and mechanical thrombectomy to remove arterial plaque and thrombi, especially in peripheral arterial disease and in-stent restenosis.
What specialties typically use this device?
Interventional cardiologists and radiologists typically use the JetStream XC/SC in vascular procedures.
What are the FDA-cleared indications?
The device is indicated for removing plaque and thrombi from arteries in patients with peripheral arterial disease and for treating in-stent restenosis.