Jetstream G2 System Models PV20300 Jetstream G2 Catheter and Control Pod PVCN100 Pv Console
Pathway Medical Technologies
FDA Clearance Information
The Jetstream G2 System, manufactured by Pathway Medical Technologies, received FDA clearance via the 510(k) pathway on March 11, 2009. It is classified as a Class 2 device under product code MCW.
What It Is
FDA-Cleared Indications
- Removal of atherosclerotic plaque from peripheral arteries.
- Removal of thrombus from peripheral arteries.
- Treatment of peripheral arterial disease involving obstructive arterial disease.
Clinical Applications
- Endovascular atherectomy to debulk plaque in peripheral arteries.
- Mechanical thrombectomy to remove thrombus from peripheral arteries.
- Treatment of peripheral arterial occlusive disease causing reduced limb blood flow.
- Use during catheter-based peripheral vascular procedures performed in a hospital or qualified outpatient endovascular setting.
Practical Considerations
- The system includes the Jetstream G2 catheter, model PV20300, and the PV Console control pod, model PVCN100.
- The catheter uses a rotating cutting mechanism and aspiration to remove obstructive material; careful advancement and operation are required to reduce the risk of vessel injury or distal embolization.
- Vessel diameter, lesion characteristics, access route, and the need for adjunctive angioplasty or stenting should be assessed before treatment.
- The device should be used only by clinicians trained in peripheral endovascular and atherectomy techniques and according to the current labeling and instructions for use.
- MRI safety depends on the specific catheter and system components and the applicable labeling; the device should not be assumed to be MRI safe without verification.
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 the Jetstream G2 System used for?
The Jetstream G2 System is used for atherectomy and mechanical thrombectomy to remove plaque and thrombus from peripheral arteries.
What specialties typically use this device?
Interventional cardiologists and vascular surgeons typically use the Jetstream G2 System in their practices.
What are the FDA-cleared indications?
The device is indicated for the removal of atherosclerotic plaque and thrombus from peripheral arteries in patients with peripheral arterial disease.