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angiojet xpeedior rheolytic thrombectomy catheter model 104307
Possis Medical
Summary: The AngioJet Xpeedior Rheolytic Thrombectomy Catheter by Possis Medical is a device used for mechanical thrombectomy in venous systems. Key evidence highlights its application in central venous sinus thrombosis and acute massive pulmonary embolism.
FDA Clearance Information
Pathway
510K
Number
K071336 ↗
Decision Date
August 24, 2007
Product Code
QEZ
Device Class
Class 2
Evidence
0 studies
The AngioJet Xpeedior Rheolytic Thrombectomy Catheter was cleared via the FDA 510(k) pathway on August 24, 2007. Manufactured by Possis Medical, it is classified as a Class 2 device under product code QEZ.
What It Is
The AngioJet Xpeedior is a rheolytic thrombectomy catheter designed to remove thrombi using high-velocity saline jets. It is intended for use in venous thrombectomy procedures, leveraging the Bernoulli principle for thrombus aspiration, maceration, and evacuation.
Clinical Applications
Commonly used in scenarios such as central venous sinus thrombosis and acute massive pulmonary embolism, the device provides an alternative to traditional revascularization strategies, especially when fibrinolytic infusion poses risks.
Evidence Summary
The literature includes four studies ranging from 2004 to 2007, encompassing case reports and observational registries. These studies explore the device's efficacy and safety in various clinical settings.
Reported Outcomes
Published studies report the AngioJet Xpeedior's effectiveness in thrombus removal in cases of acute massive pulmonary embolism and central venous sinus thrombosis. The device has shown potential in improving clinical outcomes where traditional methods are contraindicated.
Safety Profile
Reported complications include potential exacerbation of preexisting cerebral hemorrhage, particularly in cases involving central venous sinus thrombosis. The high shear stress during device operation may also affect protein viability, as noted in studies involving alteplase.
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 fully understand the long-term safety and efficacy of the device across diverse patient populations.
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 central venous sinus thrombosis and acute massive pulmonary embolism.
What outcomes have been reported in clinical studies?
Studies report effective thrombus removal and improved clinical outcomes in scenarios where traditional revascularization is contraindicated.
What complications have been reported?
Safety data indicates potential risks such as exacerbation of cerebral hemorrhage and effects on protein viability due to high shear stress.
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.