đź“Š Evidence-Based Reference
X-Press 6 French Vascular Closure System
Summary: The X-Press 6 French Vascular Closure System is a device for percutaneous suture delivery to close femoral artery access sites post-catheterization. Key evidence includes studies comparing it to manual compression, focusing on time to hemostasis and ambulation.
FDA Clearance Information
Pathway ?
PMA
Number ?
P020035 ↗
Decision Date ?
September 30, 2003
Product Code ?
MGB Device, Hemostasis, Vascular
Device Class ?
Class 3
Evidence ?
0 studies
The X-Press 6 French Vascular Closure System was cleared through the FDA PMA pathway on September 30, 2003. Manufactured by St. Jude Medical, it is classified as a Class III device.
What It Is
The X-Press 6 French Vascular Closure System is designed for the percutaneous delivery of suture to close the common femoral artery access site after catheterization procedures. It aims to reduce time to hemostasis and facilitate quicker patient recovery.
FDA-Cleared Indications
- Percutaneous delivery of suture to close a common femoral artery access site after diagnostic or interventional catheterization.
- Use in patients whose catheterization procedure used a vascular sheath 6 French or smaller.
- Intended to reduce time to hemostasis, time to ambulation of 100 feet, and time to dischargeability after diagnostic or interventional cardiac catheterization.
- May be used in patients receiving glycoprotein IIb/IIIa inhibitors when there are no complicating clinical conditions.
Clinical Applications
- Closure of the common femoral artery access site after diagnostic cardiac catheterization.
- Closure of the common femoral artery access site after interventional cardiac catheterization.
- Suture-mediated closure after catheterization performed through a sheath 6 French or smaller.
- Femoral access-site closure in appropriately selected patients receiving glycoprotein IIb/IIIa inhibitors.
Evidence Summary
The literature includes randomized controlled trials and other study types, with a focus on comparing the device to manual compression. The studies span from 2002 to 2016, providing insights into its clinical efficacy and safety.
Reported Outcomes
Published studies report that the X-Press 6 French Vascular Closure System effectively reduces time to hemostasis and ambulation compared to manual compression. The device has been shown to facilitate quicker discharge in patients undergoing cardiac procedures.
Safety Profile
Reported complications include typical risks associated with vascular closure devices, though specific adverse events were not detailed in the provided studies. Further research is needed to fully characterize the safety profile.
Evidence Limitations
The evidence is limited by the lack of detailed safety outcomes and long-term follow-up data. Additional studies are needed to compare the device with newer closure technologies and to assess long-term efficacy and safety.
Practical Considerations
- The FDA labeling specifies use with vascular sheaths 6 French or smaller.
- The device is intended for the common femoral artery access site; accurate puncture location and assessment of the access vessel are important before closure.
- It should not be assumed to be appropriate for large-bore access, nonfemoral access, or arterial sites outside the labeled indication.
- Patient selection should account for bleeding risk, anticoagulant or antiplatelet therapy, vessel anatomy, puncture complications, and other conditions that could impair hemostasis.
- MRI safety information is not provided in the supplied FDA record; consult the current device labeling and manufacturer documentation before MRI.
Frequently Asked Questions
What are the clinical indications for X-Press 6 French Vascular Closure System?
The device is indicated for closing the common femoral artery access site in patients who have undergone catheterization procedures using sheaths ≤6 French.
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 risks associated with 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.