đź“Š Evidence-Based Reference
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, Hemostasis, Vascular
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.
FDA-Cleared Indications
- Percutaneous approximation of the femoral artery.
- Reduction of time to hemostasis at femoral artery puncture sites.
- Reduction of time to ambulation after diagnostic and interventional catheterization procedures using 6- to 8-French procedural sheaths.
Clinical Applications
- Femoral artery access-site closure after diagnostic catheterization.
- Femoral artery access-site closure after interventional catheterization.
- Approximation of the femoral artery puncture site after removal of a 6- to 8-French procedural sheath.
- Facilitating earlier hemostasis and ambulation after femoral catheterization.
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.
Practical Considerations
- The FDA indication specifies use with 6- to 8-French procedural sheaths; sheath size and access-site anatomy should be confirmed before use.
- The device is intended for femoral artery puncture sites, not automatically for radial, brachial, popliteal, venous, or other access sites.
- Accurate femoral access-site location and assessment of vessel anatomy are important because high, low, calcified, diseased, or bifurcation-level punctures may increase complication risk.
- Potential complications of femoral vascular closure devices include bleeding, hematoma, arterial thrombosis or occlusion, infection, pseudoaneurysm, arteriovenous fistula, and the need for surgical or endovascular treatment.
- The FDA record provided does not establish MRI compatibility, device longevity, or a universal contraindication list; consult the current manufacturer instructions for use and institutional protocol.
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.