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AngioJet Xpeedior Rheolytic Thrombectomy Catheter Model 104307
Possis Medical
Summary: The AngioJet Xpeedior is a rheolytic thrombectomy catheter used primarily for thrombus removal in venous systems. Key evidence highlights its application in central venous sinus thrombosis and pulmonary embolism.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K071514 ↗
Decision Date ?
July 31, 2007
Product Code ?
QEZ
Device Class ?
Class 2
Evidence ?
0 studies
The AngioJet Xpeedior Rheolytic Thrombectomy Catheter was cleared by the FDA via the 510(k) pathway on July 31, 2007. It is manufactured by Possis Medical and classified as a Class 2 device.
What It Is
The AngioJet Xpeedior is a mechanical thrombectomy device that uses high-velocity saline jets to aspirate, macerate, and evacuate thrombi through the Bernoulli principle. It is intended for use in venous thrombectomy procedures.
FDA-Cleared Indications
- Removal of thrombus from blood vessels in the peripheral vasculature.
- Use during percutaneous thrombectomy procedures when thrombus obstructs blood flow.
- Use with the AngioJet system and compatible accessories according to the device labeling.
Clinical Applications
- Percutaneous removal of thrombus from peripheral veins.
- Mechanical thrombectomy for selected acute venous thrombosis.
- Removal of clot during treatment of deep vein thrombosis.
- Thrombectomy of selected thrombosed dialysis grafts or fistulas when compatible with the labeled system and configuration.
Reported off-label uses
- Treatment of selected pulmonary emboli has been reported in clinical practice, but use depends on the specific catheter labeling and may be off-label for this model.
- Treatment of cerebral venous sinus thrombosis has been described in reports and case series, but this is not assumed to be an FDA-cleared indication for this peripheral venous catheter.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
The available literature includes four studies ranging from 2004 to 2007, covering various clinical applications of the device. Study types include case reports and observational registries.
Reported Outcomes
Published studies report the AngioJet Xpeedior's efficacy in thrombus removal in cases of acute massive pulmonary embolism and central venous sinus thrombosis. The device has been shown to effectively aspirate and evacuate thrombi, improving clinical outcomes in these scenarios.
Safety Profile
Reported complications include potential exacerbation of preexisting cerebral hemorrhage in cases of central venous sinus thrombosis. The high shear stress associated with the device may also impact protein viability during thrombolytic therapy.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of large-scale randomized controlled trials. Further research is needed to establish long-term safety and efficacy across diverse patient populations.
Practical Considerations
- The catheter must be used with the compatible AngioJet console, saline supply, waste collection system, guidewire, and other accessories specified in the instructions for use.
- Vessel diameter, clot burden, lesion length, access route, and catheter compatibility should be confirmed before treatment.
- The device uses high-pressure saline jets and aspiration; careful attention to treatment time, blood loss, hemolysis, bradyarrhythmia risk, and other procedure-related complications is required.
- MRI safety depends on the catheter, any retained or implanted components, and the manufacturer's current labeling. Do not assume the device is MRI safe or MRI conditional without reviewing the instructions for use.
- Contraindications, warnings, and precautions include unsuitable vessel anatomy, inability to obtain appropriate vascular access, and conditions in which thrombectomy or anticoagulation is unsafe.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for AngioJet Xpeedior Rheolytic Thrombectomy Catheter?
The device is indicated for mechanical thrombectomy in venous systems, particularly in cases of acute massive pulmonary embolism and central venous sinus thrombosis.
What outcomes have been reported in clinical studies?
Studies have reported effective thrombus removal and improved clinical outcomes in pulmonary embolism and central venous sinus thrombosis cases.
What complications have been reported?
Reported complications include exacerbation of cerebral hemorrhage and potential impacts on protein viability during thrombolytic therapy.
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.