Jetstream Pathway Pc Atherectomy System Model OV10300
Pathway Medical Technologies
FDA Clearance Information
The Jetstream Pathway PC Atherectomy System received FDA clearance via the 510k pathway on January 23, 2009. It is manufactured by Pathway Medical Technologies and is classified as a Class 2 device under product code MCW.
What It Is
FDA-Cleared Indications
- Removal of plaque from peripheral arteries in patients with occlusive vascular disease.
- Removal of thrombus from peripheral arteries.
- Use during endovascular treatment intended to improve blood flow in diseased peripheral arteries.
Clinical Applications
- Atherectomy of peripheral arterial lesions in patients with symptomatic peripheral arterial disease.
- Mechanical thrombectomy of thrombotic material in peripheral arteries.
- Plaque and thrombus removal during lower-extremity peripheral revascularization procedures.
- Lesion preparation before adjunctive balloon angioplasty or stent placement when clinically appropriate.
Practical Considerations
- The device is selected according to the treated vessel diameter, lesion characteristics and access anatomy; operators should follow the specific device labeling for compatible guidewires, catheters and operating technique.
- Atherectomy requires fluoroscopic imaging, vascular access and appropriate training in peripheral endovascular procedures.
- Potential complications include vessel dissection or perforation, distal embolization, thrombosis, bleeding at the access site and need for additional treatment.
- MRI safety should be confirmed in the current device labeling and with the treating facility before an MRI examination; do not assume the system or any retained component is MRI safe.
- Contraindications, warnings and limitations in the FDA-cleared instructions for use should be reviewed before treatment, particularly for severely calcified, tortuous or otherwise unsuitable vessels.
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 PC Atherectomy System used for?
It is used for removing plaque and thrombus from peripheral arteries to treat peripheral arterial disease.
What specialties typically use this device?
Interventional cardiologists and vascular surgeons typically use this device in procedures aimed at revascularizing occluded arteries.
What are the FDA-cleared indications?
The device is indicated for the treatment of peripheral arterial disease by removing plaque and thrombus to improve blood flow.