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r2p destination slender guiding sheath
Terumo Medical
Summary: The r2p destination slender guiding sheath is a medical device used in neuro-interventional procedures, particularly for transradial access. It is primarily utilized by interventional radiologists and neurosurgeons.
FDA Clearance Information
Pathway
510K
Number
K171491 ↗
Decision Date
October 5, 2017
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The r2p destination slender guiding sheath was cleared through the FDA 510k pathway on October 5, 2017. Manufactured by Terumo Medical, it is classified as a Class 2 device under product code DYB.
What It Is
The r2p destination slender guiding sheath is a specialized medical device designed for vascular access during neuro-interventional procedures. It features a slender design that facilitates transradial access, offering improved torqueability and maneuverability compared to traditional transfemoral devices. This sheath is particularly useful in navigating the complex vascular anatomy of the brain.
Clinical Applications
This device is commonly used in neuro-interventional procedures such as embolization, aneurysm coiling, and other endovascular interventions. It is particularly beneficial in settings where transradial access is preferred, such as in patients with peripheral vascular disease or those requiring repeat interventions. The sheath is primarily used by interventional radiologists and neurosurgeons in hospital settings.
Indications for Use
The FDA-cleared indications suggest that this device is suitable for patients requiring neuro-interventional procedures via transradial access. It is designed to facilitate the delivery of embolization coils and other endovascular devices.
Practical Considerations
The r2p destination slender guiding sheath is typically available in a 6 French size, making it compatible with a range of neuro-interventional devices. Clinicians should be aware of its enhanced torqueability, which aids in navigating challenging vascular paths. Proper technique and familiarity with transradial access are essential for optimal use.
Related Literature
A retrospective study evaluated the efficacy and safety of the 6Fr Terumo R2P Destination Slender Guiding Sheath in 97 patients undergoing transradial neuro-interventions. The study found that the sheath was both safe and feasible for these procedures, offering improved access and maneuverability. However, as a single-institution study, the findings may not be generalizable to all clinical settings.
Frequently Asked Questions
What is the r2p destination slender guiding sheath used for?
It is used for neuro-interventional procedures, particularly those requiring transradial access.
What specialties typically use this device?
Interventional radiologists and neurosurgeons commonly use this device.
What are the FDA-cleared indications?
It is indicated for neuro-interventional procedures requiring vascular access, such as embolization and aneurysm coiling.
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.