📊 Evidence-Based Reference
AngioJet Xpeedior Rheolytic Thrombectomy Catheter Model Xpeedior 120
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 cases like pulmonary embolism and central venous sinus thrombosis.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K061951 ↗
Decision Date ?
November 22, 2006
Product Code ?
QEZ
Device Class ?
Class 2
Evidence ?
0 studies
The AngioJet Xpeedior Rheolytic Thrombectomy Catheter, manufactured by Possis Medical, was cleared by the FDA via the 510(k) pathway on November 22, 2006. It is classified as a Class 2 device under product code QEZ.
What It Is
The AngioJet Xpeedior is a mechanical thrombectomy device that employs high-velocity saline jets to aspirate, macerate, and evacuate thrombi. It is intended for use in the venous system to treat conditions like pulmonary embolism and central venous sinus thrombosis.
FDA-Cleared Indications
- FDA-cleared for rheolytic thrombectomy, or mechanical removal of thrombus, in the labeled vascular applications for the Xpeedior 120 catheter.
- Use is limited to the anatomy, vessel size, access route, and clinical indications specified in the manufacturer's FDA-cleared labeling.
- The FDA record identifies the device under product code QEZ and 510(k) K061951, cleared in 2006.
Clinical Applications
- Catheter-based removal of thrombus from labeled venous vascular anatomy.
- Mechanical treatment of acute venous thrombus when a physician determines that catheter thrombectomy is appropriate.
- Use as part of an endovascular strategy for selected thrombotic disease, according to the device instructions for use and patient anatomy.
Reported off-label uses
- Use in selected pulmonary embolism cases has been described in clinical practice and literature for rheolytic thrombectomy devices, but the specific on-label status depends on the Xpeedior 120 labeling and indication at the time of use.
- Use in cerebral venous sinus thrombosis has been reported, but neurovascular use should not be assumed to be FDA-cleared for this specific 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, comprising case reports and observational studies. These studies explore the device's efficacy and safety in various clinical contexts.
Reported Outcomes
Published studies report that the AngioJet Xpeedior is effective in thrombus removal, particularly in cases of acute massive pulmonary embolism and central venous sinus thrombosis. The device's ability to aspirate and macerate thrombi has been highlighted as a key benefit in these scenarios.
Safety Profile
Reported complications include the potential for exacerbating preexisting cerebral hemorrhage, as noted in cases of central venous sinus thrombosis. The studies emphasize the need for careful patient selection to mitigate such risks.
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 outcomes and to explore the device's efficacy across a broader range of clinical settings.
Practical Considerations
- The Xpeedior 120 is a catheter-based system used with a compatible AngioJet console, saline supply, aspiration setup, guidewire, and appropriately sized vascular access sheath.
- Operators should confirm the catheter's labeled vessel-diameter range, guidewire requirements, access compatibility, and maximum treatment time before use.
- Rheolytic thrombectomy can cause hemolysis and hemoglobinuria; monitor the patient and follow the manufacturer's recommended treatment limits and precautions.
- Potential complications include bleeding, vascular injury, perforation, distal embolization, arrhythmia, renal injury, and contrast-related complications.
- MRI safety depends on the catheter and any retained or associated components. Do not assume MRI compatibility; check the current manufacturer labeling before MRI.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for AngioJet Xpeedior Rheolytic Thrombectomy Catheter?
The device is indicated for thrombus removal 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 report effective thrombus removal in cases of pulmonary embolism and central venous sinus thrombosis, with successful aspiration and maceration of thrombi.
What complications have been reported?
Reported complications include the risk of exacerbating cerebral hemorrhage in patients with central venous sinus thrombosis, highlighting the importance of careful patient selection.
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.