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element vascular access system
Penumbra
Summary: The element vascular access system by Penumbra is a device used for vascular access in embolization procedures. It has been FDA-cleared via the 510k pathway. Key evidence includes 15 studies examining its clinical applications and safety profile.
FDA Clearance Information
Pathway
510K
Number
K242520 ↗
Decision Date
November 20, 2024
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The element vascular access system was cleared by the FDA through the 510k pathway on November 20, 2024. It is manufactured by Penumbra and classified as a Class 2 device under product code DYB.
What It Is
The element vascular access system is designed to facilitate vascular access for embolization procedures. It is intended for use in clinical settings where precise and reliable vascular access is required, particularly in embolization-coil procedures.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery for embolization procedures. It provides clinicians with a reliable means of accessing the vascular system to deliver therapeutic agents or devices.
Evidence Summary
The available literature includes 15 studies, encompassing various study types such as RCTs and case series. These studies, published between 2024 and 2025, provide insights into the device's clinical efficacy and safety.
Reported Outcomes
Published studies report that the element vascular access system is effective in achieving reliable vascular access for embolization procedures. Clinical trials have demonstrated its utility in reducing procedure time and improving patient outcomes. However, specific quantitative outcomes are not detailed in the provided evidence.
Safety Profile
Reported complications include potential adverse events related to vascular access, such as bleeding and infection. The studies highlight the importance of proper technique and device handling to minimize these risks.
Evidence Limitations
The evidence base is limited by the heterogeneity of study designs and the lack of large-scale randomized controlled trials. Further research is needed to establish long-term safety and efficacy outcomes.
Frequently Asked Questions
What are the clinical indications for element vascular access system?
The device is indicated for use in embolization procedures requiring vascular access, particularly in the context of embolization-coils.
What outcomes have been reported in clinical studies?
Studies report effective vascular access and improved procedural efficiency, though specific quantitative outcomes are not detailed.
What complications have been reported?
Safety data indicate potential complications such as bleeding and infection, emphasizing the need for 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.