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Jeti Peripheral Thrombectomy System
Walk Vascular
Summary: The JETi Peripheral Thrombectomy System is a mechanical thrombectomy device used for arterial occlusions. It is primarily used for acute limb ischemia. Limited evidence suggests its efficacy and safety.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K192439 ↗
Decision Date ?
December 9, 2019
Product Code ?
QEZ
Device Class ?
Class 2
Evidence ?
0 studies
The JETi Peripheral Thrombectomy System was cleared by the FDA through the 510(k) pathway on December 9, 2019. It is manufactured by Walk Vascular and classified as a Class 2 device.
What It Is
The JETi Peripheral Thrombectomy System is a mechanical device designed to fragment and aspirate thrombi in arterial occlusions. It is intended for use in percutaneous thrombectomy procedures, providing a minimally invasive option for treating acute limb ischemia.
FDA-Cleared Indications
- Percutaneous removal of thrombus from peripheral arteries.
- Treatment of arterial occlusions in the peripheral vasculature.
- Mechanical fragmentation and aspiration of thrombotic material to help restore blood flow.
Clinical Applications
- Percutaneous thrombectomy for acute limb ischemia caused by arterial thrombus.
- Removal of thrombus from occluded lower-extremity arteries.
- Treatment of selected peripheral arterial occlusions when rapid clot removal is needed.
- Catheter-based thrombus aspiration during an endovascular revascularization procedure.
Evidence Summary
The available literature includes a case series and several clinical trials, though many are ongoing or have unknown status. The studies focus on the device's use in arterial and venous thrombosis, with publication dates ranging from 2019 to 2024.
Reported Outcomes
Published studies report that the JETi system is effective in fragmenting and aspirating thrombi in cases of acute limb ischemia. However, detailed efficacy outcomes are limited due to the early stage of evidence and ongoing studies.
Safety Profile
Reported complications include limited data on adverse events, as the evidence is still emerging. The case series did not specify safety outcomes, indicating a need for further research to establish a comprehensive safety profile.
Evidence Limitations
The current evidence is limited by the small number of studies and the early stage of research. Many studies are ongoing, and there is a need for larger, randomized trials to better understand the device's efficacy and safety.
Practical Considerations
- The system is used through percutaneous vascular access, commonly from the common femoral artery, with fluoroscopic guidance.
- Available catheter sizes and required sheath or guidewire compatibility depend on the specific JETi system configuration; operators should follow the current instructions for use.
- It is intended for peripheral arterial use and should not be assumed to be cleared for coronary, cerebral, venous, or dialysis-access thrombectomy unless specifically stated in the applicable labeling.
- Potential complications include bleeding or hematoma at the access site, arterial dissection or perforation, distal embolization, vessel spasm, contrast reaction, kidney injury, and recurrent thrombosis.
- MRI safety depends on the individual device components and labeling. The system should be removed before MRI unless the current instructions for use identify the relevant components as MR Conditional.
Frequently Asked Questions
What are the clinical indications for JETi Peripheral Thrombectomy System?
The JETi system is indicated for the treatment of arterial occlusions, particularly in cases of acute limb ischemia.
What outcomes have been reported in clinical studies?
Studies report the device's effectiveness in thrombus fragmentation and aspiration, though detailed outcomes are limited.
What complications have been reported?
Reported complications include limited data on adverse events, with further research needed to establish a comprehensive safety profile.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.