Jetstream G3 System Model PV31300 Pv Console Model PVCN100
Pathway Medical Technologies
FDA Clearance Information
The Jetstream G3 System, manufactured by Pathway Medical Technologies, received FDA clearance via the 510(k) pathway on June 2, 2010. It is classified as a Class II medical device.
What It Is
FDA-Cleared Indications
- Removal of atherosclerotic plaque from peripheral arteries.
- Removal of thrombus from peripheral arteries.
- Use during endovascular treatment of peripheral arterial disease in appropriately selected patients.
Clinical Applications
- Atherectomy of plaque in stenotic peripheral arteries.
- Thrombectomy or removal of thrombotic material from peripheral arteries.
- Treatment of lower-extremity arterial blockages associated with peripheral arterial disease.
- Plaque modification before or during balloon angioplasty or stent placement when clinically appropriate.
Practical Considerations
- The system includes a catheter with rotating cutting elements and aspiration, used with fluoroscopic imaging and a compatible guidewire.
- Catheter sizes should be selected for the treated vessel diameter and lesion characteristics; operators must follow the applicable device labeling for size and compatibility requirements.
- Potential complications include vessel dissection, perforation, distal embolization, thrombosis, bleeding, and contrast-related or access-site complications.
- The device is intended for trained clinicians familiar with peripheral endovascular procedures. It is not a substitute for evaluation of medication therapy, angioplasty, stenting, or surgical bypass when those treatments are more appropriate.
- MRI safety depends on the specific catheter and console components and their labeling. The device should not be taken into the MRI environment unless the applicable manufacturer instructions identify the component as MR safe or MR conditional.
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 G3 System used for?
The Jetstream G3 System is used for atherectomy and thrombectomy in patients with peripheral artery disease to remove plaque and thrombus from arteries.
What specialties typically use this device?
Interventional cardiologists and vascular surgeons typically use the Jetstream G3 System.
What are the FDA-cleared indications?
The device is indicated for the treatment of peripheral artery disease by removing plaque and thrombus from arteries to improve blood flow.