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angiojet xmi catheter - rapid exchange xmi-rx
Possis Medical
Summary: The AngioJet XMI Catheter is a mechanical thrombectomy device used for removing thrombus in venous systems. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K042874 ↗
Decision Date
November 5, 2004
Product Code
QEZ
Device Class
Class 2
Evidence
0 studies
The AngioJet XMI Catheter was cleared via the FDA 510k pathway on November 5, 2004. It is manufactured by Possis Medical and classified as a Class 2 device.
What It Is
The AngioJet XMI Catheter is a rapid exchange mechanical thrombectomy device designed to remove thrombus from venous systems. It operates using high-speed saline jets to create a vacuum effect, effectively breaking up and aspirating thrombus. This device is particularly useful in situations where traditional fibrinolytic therapy is contraindicated.
Clinical Applications
The AngioJet XMI Catheter is commonly used in interventional radiology and vascular surgery settings for the treatment of deep vein thrombosis (DVT) and other venous thromboembolic events. It is particularly beneficial in patients who are at risk of bleeding complications from fibrinolytic therapy. The device is used in hospital settings, often in catheterization labs or operating rooms.
Indications for Use
The FDA indications for the AngioJet XMI Catheter include the mechanical removal of thrombus in venous systems. It is particularly indicated for patients with conditions like deep vein thrombosis or central venous sinus thrombosis where traditional thrombolytic therapy is not suitable.
Practical Considerations
The AngioJet XMI Catheter is available in various sizes to accommodate different vessel diameters. It is compatible with standard guidewires and requires a power console for operation. Clinicians should be trained in its use to optimize outcomes and minimize potential complications.
Related Literature
The linked study explored the use of the AngioJet device in treating central venous sinus thrombosis, a condition that can lead to severe neurological deficits. The study found that using the AngioJet in conjunction with systemic heparinization allowed for rapid revascularization without the need for fibrinolytic therapy, which is beneficial in patients with existing cerebral hemorrhage. However, the study is limited by its small sample size and case report nature.
Frequently Asked Questions
What is the AngioJet XMI Catheter used for?
It is used for the mechanical removal of thrombus in venous systems, particularly in cases where fibrinolytic therapy is contraindicated.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for the mechanical thrombectomy of venous thrombus, such as in deep vein thrombosis or central venous sinus thrombosis.
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.