📊 Evidence-Based Reference
Embol-X Introducer Sheath
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 ?
510(k)
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.
FDA-Cleared Indications
- Use as an introducer sheath and embolic-protection system during selected cardiac or aortic procedures.
- Capture and remove embolic material, including particulate debris, from the bloodstream during surgery.
- Use when temporary intraoperative filtration is needed to reduce the passage of procedure-related debris into the arterial circulation.
Clinical Applications
- Embolic protection during coronary artery bypass grafting.
- Embolic protection during selected open cardiac procedures.
- Embolic protection during transaortic transcatheter aortic valve implantation or replacement procedures.
- Temporary arterial access and debris capture during procedures in which manipulation of the aorta or heart may release embolic material.
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.
Practical Considerations
- The appropriate sheath and filter configuration depends on the access vessel, target anatomy, procedure, and required blood-flow characteristics; use only sizes and components specified in the current manufacturer labeling.
- The device is intended for temporary intraoperative use and is not a permanent implant. It requires fluoroscopic or direct surgical guidance, careful deployment, debris retrieval, and removal according to the instructions for use.
- Potential complications include bleeding, vessel injury, thrombosis, embolization, infection, and ischemic events. Patients with unsuitable arterial anatomy, severe access-vessel disease, or contraindications to anticoagulation may not be appropriate candidates.
- MRI safety depends on the exact device components and whether the system remains in the patient. Confirm the current manufacturer MRI labeling before an MRI examination; do not assume that the device is MR Safe.
- Compatibility with guidewires, catheters, blood-flow circuits, and other procedural equipment must be verified from the current product labeling. The system should be flushed, handled, and removed using the manufacturer's instructions.
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.