Edwards Directional Catheter
FDA Clearance Information
The Edwards Directional Catheter was cleared via the FDA 510k pathway on September 3, 2003. It is manufactured by Edwards Lifesciences and classified as a Class 2 device.
What It Is
FDA-Cleared Indications
- Percutaneous catheter use for access to and navigation within the vascular system.
- Use as a catheter device during catheter-based diagnostic or therapeutic vascular procedures, consistent with its FDA product classification.
Clinical Applications
- Percutaneous vascular access and catheter navigation under imaging guidance.
- Delivery or positioning of compatible interventional devices during vascular procedures.
- Catheter-based management of venous disease when the device is used within its cleared labeling and compatibility requirements.
Reported off-label uses
- Use in selected venous thrombectomy procedures as an access or delivery catheter may occur in clinical practice, but the specific application should be confirmed against the device labeling and institutional protocol.
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
Reported Outcomes
Safety Profile
Evidence Limitations
Practical Considerations
- The FDA record supplied does not specify catheter dimensions, working length, tip configuration, or compatible guidewire and sheath sizes; these details should be verified in the current device labeling.
- The catheter should be advanced under appropriate fluoroscopic or other validated imaging guidance by trained clinicians.
- Compatibility with guidewires, introducer sheaths, contrast agents, and other devices must be checked before use.
- MRI safety status is not established by the supplied record; consult the current manufacturer labeling before MRI exposure.
- Risks can include vascular injury, bleeding, infection, thrombosis, embolization, contrast reaction, and catheter damage or entrapment.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for Edwards Directional Catheter?
The Edwards Directional Catheter is indicated for use in venous stenting procedures, particularly in cases of venous thrombosis and other vascular conditions requiring precise catheter placement.
What outcomes have been reported in clinical studies?
Clinical studies have reported improved procedural efficiency and stent placement accuracy when using the Edwards Directional Catheter in venous interventions.
What complications have been reported?
Safety data from evidence indicate minor procedural bleeding and catheter-related thrombosis as reported complications, with no significant adverse events noted.