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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
510K
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.
Clinical Applications
Commonly used in scenarios involving acute massive pulmonary embolism and central venous sinus thrombosis, the AngioJet Xpeedior provides an alternative to traditional revascularization strategies, especially when fibrinolytic therapy poses a risk.
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.
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.