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angiojet xpeedior 120 catheter
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 under shear stress.
FDA Clearance Information
Pathway
510K
Number
K052256 ↗
Decision Date
November 10, 2005
Product Code
QEZ
Device Class
Class 2
Evidence
0 studies
The AngioJet Xpeedior 120 Catheter was cleared through the FDA 510(k) pathway on November 10, 2005. It is manufactured by Possis Medical and classified as a Class 2 device.
What It Is
The AngioJet Xpeedior 120 Catheter is a rheolytic thrombectomy device designed to remove thrombus from venous systems. It operates by using high-pressure saline jets to create a vacuum effect, aspirating thrombus material.
Clinical Applications
Commonly used in the treatment of deep vein thrombosis and other venous thromboembolic conditions, the AngioJet Xpeedior 120 Catheter is applied in scenarios where rapid thrombus removal is necessary to restore venous flow.
Evidence Summary
The available literature includes two studies, both published between 2005 and 2008. These studies involve comparisons of hemolysis and protein viability during device use, utilizing both prospective and other study designs.
Reported Outcomes
Published studies report that the AngioJet Xpeedior 120 Catheter effectively removes thrombus with a focus on minimizing hemolysis. The studies also investigate the impact of the device on protein integrity, indicating that the device can deliver thrombolytic agents without significant degradation.
Safety Profile
Reported complications include hemolysis, which is a common concern with mechanical thrombectomy devices. The studies highlight the importance of monitoring for potential adverse effects related to high shear stress during device operation.
Evidence Limitations
The evidence is limited by a small number of studies, with a focus on specific outcomes like hemolysis and protein viability. Further research is needed to evaluate long-term clinical outcomes and broader safety profiles.
Frequently Asked Questions
What are the clinical indications for AngioJet Xpeedior 120 Catheter?
The device is indicated for the removal of thrombus in venous systems, particularly in cases of deep vein thrombosis and other venous thromboembolic conditions.
What outcomes have been reported in clinical studies?
Studies report effective thrombus removal with a focus on minimizing hemolysis and maintaining protein integrity during thrombolytic agent delivery.
What complications have been reported?
Safety data indicate that hemolysis is a potential complication, necessitating careful monitoring during device use.
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.