Ensphere Tempo Jetstream Workspace Cardiology Module
Adac Laboratories
FDA Clearance Information
The Ensphere Tempo Jetstream was cleared through the FDA 510k pathway on February 6, 2004. Manufactured by Adac Laboratories, it is classified as a Class 2 device under product code LLZ.
What It Is
FDA-Cleared Indications
- Intended for use in catheter-based atherectomy procedures to remove atherosclerotic plaque from blood vessels.
- Intended for use in mechanical thrombectomy procedures to remove thrombus or clot from blood vessels.
- Use is limited to the anatomical locations, catheter configurations, and procedural indications specified in the applicable FDA-cleared labeling.
Clinical Applications
- Support of endovascular atherectomy for treatment of arterial stenosis caused by atherosclerotic plaque.
- Support of catheter-based mechanical thrombectomy for removal of arterial thrombus.
- Use during interventional procedures intended to restore or improve blood flow through an obstructed artery.
- Use in a hospital or specialized cardiovascular procedure setting by appropriately trained clinicians.
Practical Considerations
- The available record identifies the device as a cardiology module but does not provide complete catheter, vessel-size, or anatomical compatibility specifications; clinicians should consult the current FDA-cleared labeling and manufacturer instructions.
- Device selection should account for the target vessel, lesion length and morphology, access route, and compatibility with the catheter and guidewire system.
- Atherectomy and thrombectomy require fluoroscopic or other appropriate imaging guidance, sterile technique, and trained procedural personnel.
- Potential contraindications and warnings depend on the complete system labeling and may include unsuitable vessel anatomy, inability to cross the lesion safely, or risks of embolization, perforation, bleeding, and vessel injury.
- MRI safety cannot be determined from the provided FDA record; the device and all implanted or retained components should be checked against the current manufacturer MRI labeling before scanning.
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 Ensphere Tempo Jetstream used for?
It is used for atherectomy and mechanical thrombectomy in patients with arterial blockages.
What specialties typically use this device?
Interventional cardiologists primarily use this device in hospital and cardiac center settings.
What are the FDA-cleared indications?
It is indicated for the removal of plaque or thrombus in arterial vessels to restore blood flow.