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edwards embol-x introducer sheath
Edwards Lifesciences
Summary: The Edwards Embol-X Introducer Sheath is used for capturing embolic material during cardiac procedures. It is FDA 510k cleared with evidence supporting its use in embolic capture during transaortic procedures.
FDA Clearance Information
Pathway
510K
Number
K123714 ↗
Decision Date
July 24, 2013
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Edwards Embol-X Introducer Sheath was cleared by the FDA via the 510k pathway on July 24, 2013. It is manufactured by Edwards Lifesciences and classified as a Class 2 device.
What It Is
The Edwards Embol-X Introducer Sheath is a medical device designed to capture embolic material during cardiac procedures, such as transaortic transcatheter aortic valve implantation. It is intended to reduce the risk of embolic events during such interventions.
Clinical Applications
Commonly used in cardiac surgeries, the device is particularly applied during coronary artery bypass grafting and transaortic valve implantation to prevent embolic complications. It provides a practical solution for embolic protection in these high-risk procedures.
Evidence Summary
The literature includes two studies, one published in 2015 and another with an unknown date, focusing on the device's use in embolic capture during cardiac procedures. These studies provide initial insights into its clinical application.
Reported Outcomes
Published studies report the successful capture of embolic material during transaortic procedures, indicating the device's efficacy in reducing embolic events. However, specific quantitative outcomes are not detailed in the provided evidence.
Safety Profile
Reported complications include the general risks associated with intra-aortic devices, though specific adverse events are not detailed in the available studies. The safety profile appears consistent with similar devices.
Evidence Limitations
The evidence is limited by the small number of studies and lack of detailed quantitative outcomes. Further research is needed to establish comprehensive safety and efficacy profiles, including larger sample sizes and long-term follow-up.
Frequently Asked Questions
What are the clinical indications for Edwards Embol-X Introducer Sheath?
The device is indicated for capturing embolic material during cardiac procedures such as transaortic transcatheter aortic valve implantation and coronary artery bypass grafting.
What outcomes have been reported in clinical studies?
Studies report successful embolic capture during procedures, though specific quantitative outcomes are not detailed.
What complications have been reported?
Reported complications include general risks associated with intra-aortic devices, but specific adverse events are 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.