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embol-x introducer sheath
Edwards Lifesciences
Summary: The Embol-X Introducer Sheath by Edwards Lifesciences is used for capturing embolic material during cardiac procedures. Key evidence includes its use in coronary artery bypass grafting and transaortic valve implantation.
FDA Clearance Information
Pathway
510K
Number
K140398 ↗
Decision Date
March 19, 2014
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Embol-X Introducer Sheath was cleared via the FDA 510(k) pathway on March 19, 2014. It is manufactured by Edwards Lifesciences and classified as a Class 2 device under product code DYB.
What It Is
The Embol-X Introducer Sheath is a medical device designed to capture embolic material during cardiac procedures. It is used intraoperatively to reduce the risk of embolic events by filtering debris from the bloodstream.
Clinical Applications
Commonly used in procedures such as coronary artery bypass grafting and transaortic transcatheter aortic valve implantation, the device helps prevent embolic complications by capturing debris that may dislodge during surgery.
Evidence Summary
The available literature includes two studies: one published in 2015 and another with an unknown date. These studies explore the device's use in cardiac surgeries, focusing on its embolic capture capabilities.
Reported Outcomes
Published studies report the Embol-X Introducer Sheath effectively captures embolic material during cardiac procedures, potentially reducing the risk of embolic events. However, specific efficacy metrics were not detailed in the provided evidence.
Safety Profile
Reported complications include the general risks associated with intraoperative devices, but specific adverse events were not detailed in the provided studies. Further research is needed to comprehensively assess safety.
Evidence Limitations
The evidence is limited by the small number of studies and lack of detailed outcomes and safety data. Further research is necessary to establish comprehensive efficacy and safety profiles.
Frequently Asked Questions
What are the clinical indications for Embol-X Introducer Sheath?
The device is indicated for use in capturing embolic material during cardiac procedures such as coronary artery bypass grafting and transaortic valve implantation.
What outcomes have been reported in clinical studies?
Studies report effective embolic capture during cardiac procedures, though specific efficacy metrics are not detailed.
What complications have been reported?
Reported complications include general intraoperative risks, but specific adverse events are not detailed in the provided evidence.
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.