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possis angiojet x-stream rheolytic thrombectomy catheter model 103587-002
Possis Medical
Summary: The Possis AngioJet X-Stream is a rheolytic thrombectomy catheter used primarily for mechanical thrombectomy in venous systems. Key evidence highlights its efficacy in treating thromboembolic complications during peripheral endovascular procedures.
FDA Clearance Information
Pathway
510K
Number
K993564 ↗
Decision Date
April 28, 2000
Product Code
MCW
Device Class
Class 2
Evidence
0 studies
The Possis AngioJet X-Stream was cleared by the FDA via the 510(k) pathway on April 28, 2000. It is manufactured by Possis Medical and classified as a Class II device.
What It Is
The Possis AngioJet X-Stream is a rheolytic thrombectomy catheter designed to remove thrombus from blood vessels. It operates by using high-velocity saline jets to create a vacuum that breaks up and removes clots, intended for use in venous thrombectomy procedures.
Clinical Applications
Commonly used in scenarios such as acute limb ischemia, infrainguinal thromboembolism during revascularization, and occluded dialysis fistulae. It provides a minimally invasive option for thrombus removal in various vascular conditions.
Evidence Summary
The literature includes a mix of RCTs, prospective, and retrospective studies, with a total of 10 studies reviewed. The studies span from 2009 to 2016, providing insights into the device's application and outcomes.
Reported Outcomes
Published studies report the AngioJet X-Stream's effectiveness in treating thromboembolic complications, particularly in infrainguinal procedures and occluded dialysis fistulae. It has shown positive outcomes in restoring vessel patency and improving clinical symptoms.
Safety Profile
Reported complications include potential risks associated with mechanical thrombectomy, such as vessel injury and bleeding. However, the studies reviewed did not provide detailed safety data, indicating a need for further research.
Evidence Limitations
The evidence is limited by the lack of large-scale randomized controlled trials and detailed safety data. Further research is needed to establish long-term outcomes and comprehensive safety profiles.
Frequently Asked Questions
What are the clinical indications for Possis AngioJet X-Stream?
The device is indicated for mechanical thrombectomy in venous systems, particularly in cases of acute limb ischemia and thromboembolic complications during peripheral endovascular procedures.
What outcomes have been reported in clinical studies?
Studies have reported effective thrombus removal and vessel patency restoration, particularly in infrainguinal thromboembolism and occluded dialysis fistulae.
What complications have been reported?
Reported complications include potential vessel injury and bleeding, though detailed safety data is limited in the reviewed studies.
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.