Jetstream G2 System Models PV20300 Jetstream G2 Catheter and Control Pod PVCN100 Pv Console
Pathway Medical Technologies
FDA Clearance Information
The Jetstream G2 System received FDA clearance through the 510(k) pathway on January 13, 2009. It is manufactured by Pathway Medical Technologies and is classified as a Class 2 device.
What It Is
FDA-Cleared Indications
- Removal of thrombus from peripheral arteries.
- Removal of atheromatous plaque from peripheral arteries.
- Use during endovascular treatment of peripheral arterial obstruction when mechanical plaque or thrombus removal is clinically appropriate.
Clinical Applications
- Mechanical removal of plaque in peripheral arterial disease.
- Mechanical removal of thrombus from an occluded peripheral artery.
- Endovascular treatment of obstructive disease in lower-extremity peripheral arteries.
- Plaque or thrombus debulking before or with other peripheral arterial treatments, when consistent with the device labeling and procedural plan.
Practical Considerations
- The system includes a Jetstream G2 catheter and a separate control pod or console; both are required for operation.
- Catheter sizes are selected according to the target vessel diameter and lesion characteristics. The treating clinician must confirm compatibility with the intended guidewire, access system and other procedural equipment.
- The device is used under fluoroscopic imaging through vascular access, commonly from the femoral artery; local anesthesia with sedation or, less commonly, general anesthesia may be used.
- Potential complications include vessel injury, perforation, dissection, distal embolization, bleeding, thrombosis and contrast-related complications. Patient selection and contraindications should follow the current FDA-cleared labeling and manufacturer instructions.
- MRI safety depends on the specific catheter and system components and their labeling. The device should not be taken into the MRI environment unless its current instructions identify the components as MR Safe or MR Conditional under specified conditions.
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 mechanical thrombectomy and atherectomy to remove blockages in peripheral arteries.
What specialties typically use this device?
Vascular surgeons and interventional radiologists typically use the Jetstream G2 System.
What are the FDA-cleared indications?
The device is indicated for the removal of thrombus and atheromatous plaque in peripheral arteries.