đź“Š Evidence-Based Reference
angiojet xpeedior rheolytic thrombectomy catheter model 104307
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 central venous sinus thrombosis and pulmonary embolism.
FDA Clearance Information
Pathway
510K
Number
K071514 ↗
Decision Date
July 31, 2007
Product Code
QEZ
Device Class
Class 2
Evidence
0 studies
The AngioJet Xpeedior Rheolytic Thrombectomy Catheter was cleared by the FDA via the 510(k) pathway on July 31, 2007. It is manufactured by Possis Medical and classified as a Class 2 device.
What It Is
The AngioJet Xpeedior is a mechanical thrombectomy device that uses high-velocity saline jets to aspirate, macerate, and evacuate thrombi through the Bernoulli principle. It is intended for use in venous thrombectomy procedures.
Clinical Applications
Common clinical scenarios for the AngioJet Xpeedior include treatment of acute massive pulmonary embolism and central venous sinus thrombosis, particularly when traditional revascularization strategies are contraindicated.
Evidence Summary
The available literature includes four studies ranging from 2004 to 2007, covering various clinical applications of the device. Study types include case reports and observational registries.
Reported Outcomes
Published studies report the AngioJet Xpeedior's efficacy in thrombus removal in cases of acute massive pulmonary embolism and central venous sinus thrombosis. The device has been shown to effectively aspirate and evacuate thrombi, improving clinical outcomes in these scenarios.
Safety Profile
Reported complications include potential exacerbation of preexisting cerebral hemorrhage in cases of central venous sinus thrombosis. The high shear stress associated with the device may also impact protein viability during thrombolytic therapy.
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 safety and efficacy 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 acute massive pulmonary embolism and central venous sinus thrombosis.
What outcomes have been reported in clinical studies?
Studies have reported effective thrombus removal and improved clinical outcomes in pulmonary embolism and central venous sinus thrombosis cases.
What complications have been reported?
Reported complications include exacerbation of cerebral hemorrhage and potential impacts on protein viability during thrombolytic therapy.
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.