📊 Evidence-Based Reference
Pathway Access Sheath Catheter
Vertelink
Summary: The pathway access sheath catheter by Vertelink is a medical device cleared by the FDA for use in embolization-coils procedures. Key evidence highlights its application in various clinical scenarios, though specific outcomes and safety data are limited.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K030734 ↗
Decision Date ?
September 10, 2003
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The pathway access sheath catheter was cleared by the FDA through the 510(k) pathway on September 10, 2003. It is manufactured by Vertelink and classified as a Class 2 device under product code DYB.
What It Is
The pathway access sheath catheter is designed to facilitate the introduction of interventional devices into the vascular system. It is primarily used in procedures involving embolization coils, providing a conduit for device delivery.
FDA-Cleared Indications
- Use as an access sheath or catheter to facilitate the introduction of interventional devices into the vascular system.
- Use in procedures involving the delivery and placement of embolization coils.
Clinical Applications
- Providing vascular access for embolization-coil procedures.
- Introducing interventional devices into selected arteries or veins under fluoroscopic or other imaging guidance.
- Supporting catheter-based treatment of vascular abnormalities when embolization coils are used.
Reported off-label uses
- Use as a general vascular access conduit for delivery of other compatible interventional devices when the specific application is not covered by the device labeling.
- Use in selected peripheral, visceral, pelvic, or neurovascular procedures based on operator judgment and device compatibility.
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 available literature includes 11 studies, encompassing various study types such as case reports and experimental studies, with publication years ranging from 2022 to 2024. These studies explore different aspects of vascular access and interventional procedures.
Reported Outcomes
Published studies report varied outcomes related to the use of the pathway access sheath catheter, though specific efficacy data is not detailed in the provided evidence. The studies highlight its role in facilitating complex vascular procedures.
Safety Profile
Reported complications include potential risks associated with vascular access procedures, such as bleeding and vessel injury. However, specific safety data from the provided studies is limited.
Evidence Limitations
The evidence base for the pathway access sheath catheter is limited by a lack of large-scale randomized controlled trials. Further research is needed to better understand its efficacy and safety profile in diverse clinical settings.
Practical Considerations
- The appropriate sheath diameter, length, and configuration depend on the access site, target vessel, and device being introduced.
- Confirm compatibility with the guidewire, diagnostic or delivery catheter, embolization coil system, and any other interventional device before use.
- Placement is generally performed through percutaneous vascular access with fluoroscopic guidance, often using local anesthesia with or without moderate sedation.
- Review the current manufacturer instructions for use for insertion technique, flushing, maximum pressure, and handling limitations.
- MRI safety should not be assumed from the 510(k) clearance alone; verify the exact device labeling and conditions before an MRI examination.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for the pathway access sheath catheter?
The device is indicated for use in procedures involving embolization coils, providing vascular access for interventional devices.
What outcomes have been reported in clinical studies?
Specific outcomes are not detailed in the provided evidence, but the device is noted for its role in facilitating complex vascular procedures.
What complications have been reported?
Reported complications include risks typical of vascular access procedures, such as bleeding and vessel injury, though specific data is limited.
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.