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cardiva vascade vascular closure system vcs
Cardiva Medical
Summary: The Cardiva Vascade Vascular Closure System is a device used for closing femoral vascular access sites. It is primarily used in catheter-based procedures to achieve hemostasis. Key evidence highlights its efficacy in achieving hemostasis in 93.8% of cases.
FDA Clearance Information
Pathway PMA
Number P120016 ↗
Decision Date February 5, 2019
Product Code MGB
Device Class Class 3
Evidence 0 studies
The Vascade Vascular Closure System by Cardiva Medical was cleared through the FDA PMA pathway on February 5, 2019. It is classified as a Class 3 medical device.
What It Is
The Vascade Vascular Closure System is a vascular closure device designed to achieve hemostasis at femoral access sites following catheter-based procedures. It uses a collagen-based mechanism to seal the access site and is intended for use in patients aged 18 and older.
Clinical Applications
Commonly used in interventional cardiology and electrophysiology procedures, the Vascade system is applied to close femoral access sites post-procedure. It is particularly useful in scenarios where rapid hemostasis is required to minimize bleeding complications.
Evidence Summary
The available literature includes a mix of retrospective and prospective studies, as well as randomized controlled trials, with a total of 9 studies reviewed. The studies span from 2016 to 2025, providing a comprehensive overview of the device's clinical performance.
Reported Outcomes
Published studies report that the Vascade Vascular Closure System achieves hemostasis in 93.8% of cases, with successful closure in 30 out of 32 deployments in one study. Another study compared its efficacy to manual compression, highlighting its utility in multiple access site closures.
Safety Profile
Reported complications include minor events in 5 cases and a major event in 1 case out of 32 procedures. Post-marketing surveillance data from the MAUDE database provides additional insights into adverse events and modes of failure.
Evidence Limitations
The evidence is limited by the small sample sizes in some studies and the retrospective nature of certain analyses. Further research is needed to explore long-term outcomes and compare efficacy across different patient populations.
Frequently Asked Questions
What are the clinical indications for Cardiva Vascade Vascular Closure System?
The device is indicated for closure of femoral vascular access sites in patients aged 18 and older following catheter-based procedures.
What outcomes have been reported in clinical studies?
Studies report a 93.8% success rate in achieving hemostasis, with favorable comparisons to manual compression in multiple access site closures.
What complications have been reported?
Safety data indicate minor complications in 5 cases and a major complication in 1 case out of 32 procedures, with additional insights from the MAUDE database.
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.