Jetstream Cavity Preparation System
Dove Systems
FDA Clearance Information
The Jetstream Cavity Preparation System was cleared through the FDA 510(k) pathway on March 7, 1996. Manufactured by Dove Systems, it is classified as a Class 2 medical device.
What It Is
FDA-Cleared Indications
- Removal of atherosclerotic plaque from arterial vessels.
- Removal of thrombus from arterial vessels.
Clinical Applications
- Mechanical removal of plaque during endovascular treatment of an arterial blockage.
- Mechanical removal of thrombus during an arterial intervention.
- Vessel preparation before another endovascular treatment, when consistent with the device labeling and anatomy.
- Treatment of arterial lesions in patients whose anatomy and clinical condition meet the device labeling requirements.
Practical Considerations
- The system is available in device configurations intended for different vessel diameters; the treating physician selects the appropriate size based on the target vessel and lesion.
- It is used over a compatible guidewire under fluoroscopic imaging, with aspiration of removed material through the catheter system.
- Use requires training in atherectomy, thrombectomy, guidewire manipulation and management of potential embolic or vessel-wall complications.
- The record identifies the device as a Class II 510(k)-cleared device, K955050, cleared in 1996; current labeling and instructions for use should be checked before use.
- MRI safety cannot be determined from the provided FDA record. The current manufacturer labeling should be consulted before an MRI examination.
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 Cavity Preparation System used for?
It is used for removing plaque and thrombus from arterial vessels to restore blood flow in patients with peripheral or coronary artery disease.
What specialties typically use this device?
Interventional cardiologists and vascular surgeons typically use this device in endovascular procedures.
What are the FDA-cleared indications?
The device is indicated for the removal of atherosclerotic plaque and thrombus from arterial vessels in patients with peripheral or coronary artery disease.