📊 Evidence-Based Reference
Destination Renal Guiding Sheath
Summary: The destination renal guiding sheath by Terumo Medical is a device used primarily in embolization procedures. It is FDA 510k cleared and linked to five studies, though specific outcomes and safety data are not detailed.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K081045 ↗
Decision Date ?
May 28, 2008
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The destination renal guiding sheath was cleared by the FDA via the 510k pathway on May 28, 2008. It is manufactured by Terumo Medical and classified as a Class 2 device under product code DYB.
What It Is
The destination renal guiding sheath is a medical device designed to facilitate the delivery of embolization coils during interventional procedures. It is intended for use in renal interventions, providing support and guidance for other instruments.
FDA-Cleared Indications
- Used to introduce interventional devices into the peripheral vasculature.
- Provides vascular access and support for delivery of compatible diagnostic or therapeutic devices.
- FDA-cleared as a Class II device under product code DYB through the 510(k) pathway.
Clinical Applications
- Selective catheter access during renal artery interventions.
- Delivery of compatible embolization devices during arterial embolization procedures.
- Support for diagnostic angiography and other peripheral vascular interventions.
- Access to selected visceral or peripheral arteries when the sheath size and anatomy are appropriate.
Reported off-label uses
- Use as a guiding sheath for embolization in nonrenal visceral arteries, including selected pelvic or gastrointestinal vessels, when chosen by the treating physician.
- Use in complex peripheral endovascular procedures requiring additional catheter support beyond the labeled application.
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 five studies linked to the device, though specific details on study types, sample sizes, and date ranges are not provided. The studies are registered on clinical trial databases but lack detailed outcomes and safety data.
Reported Outcomes
Published studies report limited specific outcomes related to the destination renal guiding sheath. The studies are primarily focused on procedural interventions, but detailed efficacy findings are not available from the provided evidence.
Safety Profile
Reported complications include general procedural risks associated with embolization and renal interventions. However, specific adverse events related to the device are not detailed in the provided evidence.
Evidence Limitations
The evidence base for the destination renal guiding sheath is limited, with a lack of detailed study outcomes and safety data. Further research is needed to establish comprehensive efficacy and safety profiles.
Practical Considerations
- The appropriate sheath diameter and working length depend on the access route, target vessel, anatomy, and devices being delivered; confirm compatibility before use.
- The sheath is generally introduced through percutaneous arterial access, commonly the femoral or radial artery, under fluoroscopic guidance.
- Use requires sterile technique, anticoagulation and contrast management as clinically appropriate, and monitoring for bleeding, arterial injury, thrombosis, infection, and contrast-related complications.
- MRI safety should not be assumed from the 510(k) clearance. Check the current manufacturer labeling for the specific model before MRI exposure.
- This is a single-use intravascular device and is not intended to remain implanted permanently. It should not be used when vascular access is unsafe or when the target anatomy cannot accommodate the device.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for destination renal guiding sheath?
The device is indicated for use in embolization procedures, particularly in renal interventions, to facilitate the delivery of embolization coils.
What outcomes have been reported in clinical studies?
Specific outcomes from clinical studies are not detailed in the provided evidence, highlighting a gap in available data.
What complications have been reported?
Safety data from the evidence is limited, with general procedural risks noted but no specific complications detailed for the device.
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.