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alviguide blue interventional cardiology guiding catheter
Alvimedica Tibbi Urunler Sanayi Ve Dis Ticaret A.S
Summary: The Alviguide Blue is a guiding catheter used in interventional cardiology, primarily for percutaneous coronary interventions (PCI). Key evidence suggests its role in facilitating intracoronary imaging-guided PCI.
FDA Clearance Information
Pathway
510K
Number
K141529 ↗
Decision Date
December 3, 2014
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Alviguide Blue Interventional Cardiology Guiding Catheter was cleared by the FDA via the 510(k) pathway on December 3, 2014. It is manufactured by Alvimedica Tibbi Urunler Sanayi Ve Dis Ticaret A.S and classified as a Class 2 device.
What It Is
The Alviguide Blue is a guiding catheter designed for use in interventional cardiology procedures. It aids in the delivery of devices and contrast media to the coronary arteries, facilitating procedures such as PCI.
Clinical Applications
This device is commonly used in procedures requiring precise navigation and placement of interventional tools within the coronary vasculature, particularly in PCI where intracoronary imaging is utilized.
Evidence Summary
The available literature includes four studies, encompassing various study designs such as RCTs and retrospective analyses, published between 2021 and 2025. These studies explore the device's application in PCI and its economic implications.
Reported Outcomes
Published studies report that intracoronary imaging-guided PCI using devices like the Alviguide Blue can result in larger balloon/stent diameters and longer stents. Additionally, tailored hydration strategies have been shown to reduce the risk of contrast-induced acute kidney injury in PCI patients.
Safety Profile
Reported complications include the potential for contrast-induced acute kidney injury, which can be mitigated by tailored hydration strategies. No device-specific adverse events were detailed in the provided studies.
Evidence Limitations
The evidence is limited by a lack of large-scale, long-term studies specifically evaluating the Alviguide Blue. Further research is needed to fully understand its safety profile and long-term outcomes in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Alviguide Blue Interventional Cardiology Guiding Catheter?
The device is indicated for use in interventional cardiology procedures, particularly for facilitating PCI with intracoronary imaging.
What outcomes have been reported in clinical studies?
Studies report improved stent placement outcomes and reduced risk of acute kidney injury with tailored hydration during PCI.
What complications have been reported?
Safety data indicate a risk of contrast-induced acute kidney injury, which can be managed with appropriate hydration strategies.
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.