Jetstream Workspace
Adac Laboratories
FDA Clearance Information
The Jetstream Workspace was cleared through the FDA 510k pathway on November 3, 2004. Manufactured by Adac Laboratories, it is classified as a Class 2 device under product code KPS.
What It Is
FDA-Cleared Indications
- Removal of atherosclerotic plaque from peripheral arterial lesions.
- Removal of thrombotic material from peripheral arteries.
- Treatment of arterial blockages using catheter-based mechanical atherectomy or thrombectomy.
Clinical Applications
- Debulking peripheral arterial plaque before or during endovascular treatment.
- Removing thrombus from peripheral arteries when mechanical thrombectomy is indicated.
- Treating obstructive lesions in peripheral arteries through a catheter-based procedure.
- Preparing a diseased arterial segment for adjunctive balloon angioplasty or other endovascular therapy.
Practical Considerations
- The device should be used by clinicians trained in peripheral atherectomy and thrombectomy techniques.
- The appropriate catheter or working diameter depends on the target vessel and lesion characteristics; use only compatible guidewires, catheters and accessories specified in the device labeling.
- Angiographic imaging is used to select the treatment segment and assess vessel patency before and after treatment.
- Potential complications of peripheral atherectomy or thrombectomy include distal embolization, vessel dissection or perforation, thrombosis, bleeding and restenosis.
- MRI safety depends on the specific device components and labeling; the device should not be assumed to be MRI safe without checking the current manufacturer instructions.
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 removing plaque and thrombus from arterial vessels, particularly in patients with peripheral artery disease.
What specialties typically use this device?
Interventional cardiologists and vascular surgeons commonly use this device in procedures to treat arterial blockages.
What are the FDA-cleared indications?
The device is cleared for use in atherectomy and mechanical thrombectomy procedures to treat arterial blockages caused by plaque and thrombus.