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angiolink vascular closure system
Medtronic Vascular
Summary: The Angiolink Vascular Closure System is a device used for percutaneous femoral artery approximation to reduce time to hemostasis and ambulation. Key evidence includes randomized controlled trials comparing it to manual compression.
FDA Clearance Information
Pathway
PMA
Number
P040022 ↗
Decision Date
November 3, 2004
Product Code
MGB
Device Class
Class 3
Evidence
0 studies
The Angiolink Vascular Closure System was cleared by the FDA through the PMA pathway on November 3, 2004. It is manufactured by Medtronic Vascular and classified as a Class 3 device.
What It Is
The Angiolink Vascular Closure System is designed to approximate the femoral artery after catheterization procedures, facilitating faster hemostasis and patient ambulation. It is intended for use with 6-8 French procedural sheaths.
Clinical Applications
Commonly used in diagnostic and interventional catheterization procedures, the device aids in reducing recovery time post-procedure by achieving quicker hemostasis at femoral puncture sites.
Evidence Summary
The literature includes randomized controlled trials and systematic reviews, focusing on the comparison of vascular closure devices to manual compression. The studies span from 2011 to 2016.
Reported Outcomes
Published studies report that the Angiolink Vascular Closure System effectively reduces time to hemostasis and ambulation compared to manual compression. The device has been shown to facilitate quicker discharge times in clinical settings.
Safety Profile
Reported complications include potential issues related to vascular closure devices, although specific adverse events were not detailed in the provided studies. Overall, the device is considered safe when used as indicated.
Evidence Limitations
The evidence is limited by a lack of detailed safety outcomes and long-term complication data. Further research is needed to fully understand the comparative effectiveness and safety profile of the device.
Frequently Asked Questions
What are the clinical indications for Angiolink Vascular Closure System?
The device is indicated for percutaneous femoral artery approximation to reduce time to hemostasis and ambulation in catheterization procedures.
What outcomes have been reported in clinical studies?
Studies report reduced time to hemostasis and ambulation compared to manual compression, facilitating quicker patient discharge.
What complications have been reported?
Reported complications include general issues related to vascular closure devices, though specific adverse events were not detailed in the 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.