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angiojet xpeedior 120 catheter and angiojet power pulse spray ancillary kit
Possis Medical
Summary: The AngioJet Xpeedior 120 Catheter is a mechanical thrombectomy device used primarily for venous thrombus removal. Key evidence includes studies on hemolysis and protein viability.
FDA Clearance Information
Pathway
510K
Number
K040013 ↗
Decision Date
May 18, 2004
Product Code
QEZ
Device Class
Class 2
Evidence
0 studies
The AngioJet Xpeedior 120 Catheter was cleared by the FDA via the 510(k) pathway on May 18, 2004. It is manufactured by Possis Medical and is classified as a Class 2 device.
What It Is
The AngioJet Xpeedior 120 Catheter is a mechanical thrombectomy device designed to remove thrombi from venous systems. It operates by using high-velocity saline jets to break up and remove clots.
Clinical Applications
Commonly used in scenarios involving venous thromboembolism, the AngioJet Xpeedior 120 Catheter is employed in interventional radiology and vascular surgery to restore blood flow in occluded veins.
Evidence Summary
The available literature includes two studies published between 2005 and 2008. These studies focus on hemolysis and protein viability, utilizing both prospective and retrospective methodologies.
Reported Outcomes
Published studies report that the AngioJet Xpeedior 120 Catheter effectively removes thrombi with a focus on minimizing hemolysis. The device has been shown to maintain the viability of proteins such as alteplase when delivered through the catheter.
Safety Profile
Reported complications include hemolysis, as studied in a porcine model. The safety profile regarding protein integrity under high shear stress has been characterized, showing no significant adverse effects.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of large-scale clinical trials. Further research is needed to explore long-term outcomes and broader clinical applications.
Frequently Asked Questions
What are the clinical indications for AngioJet Xpeedior 120 Catheter?
The device is indicated for mechanical thrombectomy in venous thromboembolism cases.
What outcomes have been reported in clinical studies?
Studies have reported effective thrombus removal with minimal hemolysis and maintained protein viability.
What complications have been reported?
Safety data indicate hemolysis as a potential complication, with no significant adverse effects on protein integrity.
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.