đź“Š Evidence-Based Reference
Cardiva Vascade Vascular Closure System Vcs
Product: Cardiva VASCADE MVP VVCS 6-12F — all models and sizes
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, Hemostasis, Vascular
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.
FDA-Cleared Indications
- Use for achieving hemostasis at femoral arterial or venous access sites after catheter-based procedures.
- Intended for use in adults age 18 years and older.
- Applicable to the VASCADE Vascular Closure System device configurations covered by FDA PMA P120016.
Clinical Applications
- Closure of femoral arterial access sites after interventional cardiology procedures.
- Closure of femoral venous access sites after electrophysiology procedures.
- Hemostasis after removal of catheter sheaths used during diagnostic or therapeutic catheter-based procedures.
- Use when a collagen-based closure method is selected to reduce the need for prolonged manual compression.
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.
Practical Considerations
- The system is intended for femoral access sites; the operator must confirm that the access vessel, puncture location and sheath size meet the device instructions for use.
- Proper placement depends on imaging or angiographic assessment of the puncture site and vessel anatomy, along with removal of the access sheath according to the labeled technique.
- Potential complications include bleeding, hematoma, infection, vessel injury, thrombosis, infection and need for additional compression or treatment.
- MRI conditions and safety labeling should be checked in the current instructions for use for the specific VASCADE model; device-specific MR status should not be assumed.
- The device is single-use. It does not permanently reinforce the vessel, and the collagen component is absorbed over time.
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.