đź“Š Evidence-Based Reference
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Pulnovo Medical (Wuxi)
Summary: The introducer sheath by Pulnovo Medical is a device used in vascular access procedures, primarily for embolization-coils. Key evidence highlights its role in reducing radial artery complications.
FDA Clearance Information
Pathway
510K
Number
K242756 ↗
Decision Date
November 8, 2024
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The introducer sheath by Pulnovo Medical received FDA clearance through the 510(k) pathway on November 8, 2024. It is classified as a Class 2 device under product code DYB.
What It Is
The introducer sheath is a medical device designed to facilitate vascular access during procedures such as embolization. It provides a conduit for the insertion of other instruments into the vasculature, minimizing trauma to the vessel.
Clinical Applications
Commonly used in procedures requiring vascular access, the introducer sheath is particularly useful in embolization-coil placements. It helps in reducing the risk of arterial damage during interventions.
Evidence Summary
The literature includes 10 studies, ranging from randomized controlled trials to systematic reviews, published between 2021 and 2025. These studies explore various aspects of vascular access and device efficacy.
Reported Outcomes
Published studies report that the introducer sheath effectively minimizes radial artery overstretch and spasm during procedures. It is associated with improved procedural outcomes in embolization-coil placements.
Safety Profile
Reported complications include radial artery spasm and potential occlusion, as noted in studies focusing on sheath size and vascular compatibility. Overall, the device is considered safe with proper use.
Evidence Limitations
Current evidence is limited by the small sample sizes and the need for long-term follow-up studies. Further research is needed to explore the device's efficacy in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for the introducer sheath?
The introducer sheath is indicated for use in vascular access procedures, particularly in embolization-coil placements.
What outcomes have been reported in clinical studies?
Studies report effective reduction in radial artery complications and improved procedural outcomes.
What complications have been reported?
Safety data indicate potential for radial artery spasm and occlusion, though these are minimized with proper technique.
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.