📊 Evidence-Based Reference
Edwards Lifesciences Percutaneous Sheath Introducers with Oligon Material
Summary: The Edwards Lifesciences percutaneous sheath introducers are used in vascular access procedures, primarily for embolization-coils. Key evidence highlights their use in complex interventions like transcatheter aortic valve implantation.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K014052 ↗
Decision Date ?
March 8, 2002
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The device was cleared by the FDA via the 510(k) pathway on March 8, 2002. It is manufactured by Edwards Lifesciences and classified as a Class 2 medical device.
What It Is
The Edwards Lifesciences percutaneous sheath introducers are designed to facilitate vascular access for the delivery of embolization coils and other interventional devices. They are made with oligon material, enhancing flexibility and ease of insertion.
FDA-Cleared Indications
- To provide vascular access for the introduction of catheters and other interventional devices.
- To facilitate delivery of embolization coils and comparable devices during endovascular procedures.
Clinical Applications
- Providing access for embolization procedures in which coils or other therapeutic devices are delivered through a catheter.
- Establishing a vascular conduit for diagnostic or therapeutic endovascular catheter procedures.
- Supporting catheter-based interventions that require percutaneous access to the arterial or venous circulation.
Reported off-label uses
- Use as vascular access during transcatheter aortic valve implantation and other structural-heart procedures, depending on the specific sheath configuration and labeling.
- Use during selected neurointerventional, visceral, pelvic, and peripheral embolization procedures when the introducer is compatible with the planned catheter system.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
The literature includes two studies, one from 2016 and another projected for 2025. These studies encompass a range of methodologies, including case reports and procedural descriptions, focusing on the device's application in complex interventions.
Reported Outcomes
Published studies report the successful use of the Edwards Lifesciences sheath introducers in facilitating complex procedures like transcatheter aortic valve implantation. The device's design allows for effective vascular access, contributing to procedural success.
Safety Profile
Reported complications include rare instances of device embolization, as noted in a case involving a patent foramen ovale occluder. Overall, the device is considered safe when used as intended, with complications being infrequent.
Evidence Limitations
The current evidence is limited by the small number of studies and the lack of large-scale randomized controlled trials. Further research is needed to fully understand the long-term safety and efficacy of these introducers in diverse clinical settings.
Practical Considerations
- Available sizes, usable length, dilator configuration, and maximum compatible catheter or guidewire diameter should be confirmed in the current product labeling.
- The introducer is inserted percutaneously over a guidewire, commonly through the femoral, radial, jugular, or another suitable vascular access site, using fluoroscopic or other imaging guidance.
- Compatibility with the planned catheter, embolization coil delivery system, guidewire, contrast media, and hemostasis method must be checked before use.
- MRI safety depends on the exact model and whether the device remains in the patient; consult the current Edwards labeling and institutional MRI policy.
- Potential complications include bleeding, hematoma, infection, vessel injury, thrombosis, embolization, air entry, and damage to the access vessel. The device is generally intended for single use and is removed after the procedure unless its labeling states otherwise.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for Edwards Lifesciences percutaneous sheath introducers?
They are indicated for use in vascular access procedures, particularly for embolization-coils and transcatheter interventions.
What outcomes have been reported in clinical studies?
Studies report successful facilitation of complex procedures like transcatheter aortic valve implantation.
What complications have been reported?
Safety data indicate rare complications such as device embolization, with overall infrequent adverse events.
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.