Jetstream Pathway Pv Atherectomy System Model PV10300 PVCN100
Pathway Medical Technologies
FDA Clearance Information
The Jetstream Pathway PV Atherectomy System, manufactured by Pathway Medical Technologies, was cleared by the FDA via the 510k pathway on October 6, 2008. 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.
Clinical Applications
- Peripheral arterial atherectomy to debulk plaque that narrows or blocks an artery.
- Mechanical thrombectomy to remove thrombus from a peripheral artery.
- Endovascular treatment of peripheral arterial blockages when plaque or thrombus is limiting blood flow.
- Use in catheter-based peripheral vascular procedures performed through arterial access under imaging guidance.
Practical Considerations
- The system includes catheter sizes intended for different peripheral vessel diameters; the treating clinician selects the appropriate size based on vessel anatomy and lesion characteristics.
- The device uses a rotating cutting mechanism with aspiration, so operators need training in rotational atherectomy, aspiration, wire positioning and catheter handling.
- Treatment is performed through arterial access, commonly from the common femoral artery, with fluoroscopic guidance; access from other arterial sites may be selected based on anatomy.
- The device is intended for peripheral arteries and should not be assumed to be suitable for coronary, cerebral or other vascular beds unless specifically authorized by its labeling.
- MRI safety depends on the exact system components and whether any device components remain in the patient. The current manufacturer labeling should be reviewed before MRI.
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 Pathway PV Atherectomy System used for?
It is used for removing atherosclerotic plaque and thrombus from peripheral arteries to treat peripheral artery disease.
What specialties typically use this device?
Interventional cardiologists and vascular surgeons commonly use this device in endovascular procedures.
What are the FDA-cleared indications?
The device is indicated for the removal of atherosclerotic plaque and thrombus in peripheral arteries, aiding in the treatment of peripheral artery disease.