Jetstream Navitus System Jetstream G3 Sf System Jetstream G3 Se System Jetstream G3 L System
Pathway Medical Technologies
FDA Clearance Information
The Jetstream Navitus System was cleared by the FDA via the 510k pathway on April 20, 2011. Manufactured by Pathway Medical Technologies, it is a Class 2 device.
What It Is
FDA-Cleared Indications
- Removal of plaque from peripheral arterial vessels.
- Removal of thrombus from peripheral arterial vessels.
Clinical Applications
- Atherectomy of peripheral arterial blockages caused by atherosclerotic plaque.
- Thrombectomy for thrombus within peripheral arteries.
- Endovascular treatment of peripheral arterial disease involving vessels that can be reached with the device.
- Use during catheter-based peripheral vascular procedures under imaging guidance.
Practical Considerations
- The system includes catheter sizes and configurations intended for different peripheral vessel diameters; the treating clinician selects the appropriate system for the target anatomy.
- The catheter is used over a compatible guidewire and requires the associated drive or power console for operation.
- Treatment is performed with fluoroscopic imaging, typically through arterial access such as the common femoral artery, although another access site may be selected based on the anatomy.
- Atherectomy can cause distal embolization, vessel injury, perforation, dissection, bleeding, or need for additional treatment; patient selection and technique are important.
- MRI safety depends on the specific components and whether any device remains in the patient. The product labeling should be checked before MRI, and the system should not be assumed to be MRI safe.
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 Navitus System used for?
It is used for removing plaque and thrombus from peripheral arterial vessels to treat peripheral artery disease.
What specialties typically use this device?
Interventional cardiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
It is indicated for removing plaque and thrombus in patients with peripheral artery disease to restore blood flow.