Jetstream Workspace
Adac Laboratories
FDA Clearance Information
The Jetstream Workspace was cleared through the FDA 510(k) pathway on May 1, 2006. Manufactured by Adac Laboratories, it is classified as a Class 2 device under product code LLZ.
What It Is
FDA-Cleared Indications
- Treatment of peripheral arterial lesions by atherectomy.
- Removal of thrombus from peripheral arterial vessels by mechanical thrombectomy.
- Use in arterial vessels when plaque or thrombus is obstructing blood flow, according to the cleared device labeling.
Clinical Applications
- Atherectomy for plaque-related peripheral arterial obstruction.
- Mechanical thrombectomy for thrombus in peripheral arteries.
- Endovascular treatment of arterial occlusions in the lower extremities.
- Plaque or thrombus removal before or as part of another peripheral vascular intervention.
Practical Considerations
- The appropriate device size depends on the target vessel diameter and lesion characteristics; clinicians should use the sizing information in the current instructions for use.
- The device is used over a compatible guidewire and through an appropriate catheter or access system under fluoroscopic imaging.
- Use requires training in peripheral endovascular atherectomy and thrombectomy techniques, including management of embolization, perforation and other vascular complications.
- MRI safety depends on the specific device components and whether any portion remains in the patient; consult the current labeling before an MRI examination.
- Contraindications and warnings include factors such as unsuitable vessel size or anatomy, inability to safely cross the lesion, and patient conditions that increase procedural bleeding or vascular risk.
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 Workspace used for?
The Jetstream Workspace is used for atherectomy and mechanical thrombectomy to remove blockages in arterial vessels.
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 removing arterial blockages due to plaque or thrombus, particularly in patients with peripheral artery disease.