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Terumo Medical
Summary: The Destination Guiding Sheaths by Terumo Medical are used for neurovascular and peripheral interventions. Key evidence highlights their feasibility and safety in transradial neuro-interventional procedures.
FDA Clearance Information
Pathway
510K
Number
K172995 ↗
Decision Date
November 21, 2017
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Destination Guiding Sheaths were cleared by the FDA via the 510(k) pathway on November 21, 2017. Manufactured by Terumo Medical, they are classified as Class 2 devices.
What It Is
The Destination Guiding Sheaths are designed for use in neurovascular and peripheral interventions. They facilitate the introduction of diagnostic or therapeutic devices into the vasculature, particularly through transradial access.
Clinical Applications
These sheaths are commonly used in procedures requiring vascular access, such as embolization and thrombectomy. They are particularly useful in scenarios where transradial access is preferred over transfemoral access.
Evidence Summary
The available literature includes five studies, with a mix of retrospective series and clinical trials. The studies span from 2017 to 2025, focusing on the efficacy and safety of the sheaths in various vascular interventions.
Reported Outcomes
Published studies report that the Destination Guiding Sheaths are effective in facilitating neuro-interventional procedures, particularly with transradial access. The 6Fr Terumo R2P Destination Slender Guiding Sheath showed promising results in terms of safety and feasibility.
Safety Profile
Reported complications include issues related to torqueability and access site complications, particularly in transradial procedures. However, the studies generally indicate a favorable safety profile for the sheaths.
Evidence Limitations
The evidence is limited by the small number of studies and the retrospective nature of some data. Further research is needed to explore long-term outcomes and compare the sheaths with other access devices.
Frequently Asked Questions
What are the clinical indications for Destination Guiding Sheaths?
The sheaths are indicated for use in neurovascular and peripheral interventions, such as embolization and thrombectomy, particularly when transradial access is preferred.
What outcomes have been reported in clinical studies?
Studies report effective facilitation of neuro-interventional procedures with a favorable safety profile, especially with the 6Fr Terumo R2P Destination Slender Guiding Sheath.
What complications have been reported?
Safety data indicate complications related to torqueability and access site issues, but overall, the sheaths have a favorable safety profile.
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.