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renal guiding sheath
Terumo Medical
Summary: The renal guiding sheath by Terumo Medical is used primarily for embolization procedures. Key evidence highlights its role in reducing radiation exposure during flexible ureteroscopy.
FDA Clearance Information
Pathway
510K
Number
K012854 ↗
Decision Date
November 21, 2001
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The renal guiding sheath was cleared by the FDA through the 510(k) pathway on November 21, 2001. It is manufactured by Terumo Medical and classified as a Class 2 device.
What It Is
The renal guiding sheath is a medical device designed to facilitate the delivery of embolization coils and other devices during interventional procedures. It is intended for use in renal and other vascular interventions.
Clinical Applications
Commonly used in procedures such as coil embolization of renal artery aneurysms, the renal guiding sheath aids in the precise placement of interventional devices. It is particularly useful in reducing radiation exposure during flexible ureteroscopy.
Evidence Summary
The literature includes 14 studies, with a mix of retrospective and prospective designs, spanning from 2023 to 2025. These studies explore various clinical applications and safety profiles of the renal guiding sheath.
Reported Outcomes
Published studies report that the renal guiding sheath is effective in facilitating embolization procedures with no significant differences in stone-free rates or complications between groups using fluoroscopy and those without ionizing radiation. The device supports minimally invasive interventions with satisfactory clinical outcomes.
Safety Profile
Reported complications include no significant differences in adverse events between groups using the sheath with or without fluoroscopy. The device is associated with reduced radiation exposure during procedures.
Evidence Limitations
Current evidence is limited by the small number of studies focusing specifically on the renal guiding sheath. Further research is needed to explore long-term outcomes and broader clinical applications.
Frequently Asked Questions
What are the clinical indications for the renal guiding sheath?
The renal guiding sheath is indicated for use in embolization procedures, particularly in renal and vascular interventions.
What outcomes have been reported in clinical studies?
Studies report effective facilitation of embolization procedures with no significant differences in stone-free rates or complications.
What complications have been reported?
Safety data indicate no significant differences in adverse events, with reduced radiation exposure noted during procedures.
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.