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r2p destination slender guiding sheath
Terumo Medical
Summary: The r2p destination slender guiding sheath is a medical device used for transradial neuroendovascular procedures. It is primarily utilized by interventional radiologists and neuro-interventionalists.
FDA Clearance Information
Pathway
510K
Number
K193125 ↗
Decision Date
January 6, 2020
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The r2p destination slender guiding sheath was cleared through the FDA 510(k) pathway on January 6, 2020. It is manufactured by Terumo Medical and classified as a Class 2 device.
What It Is
The r2p destination slender guiding sheath is a specialized catheter designed for use in transradial access procedures, particularly in neuroendovascular interventions. It provides the necessary support and torqueability to navigate the vascular system via the radial artery, which is less invasive compared to traditional transfemoral approaches. This device is part of a growing trend towards minimally invasive procedures that aim to reduce patient recovery time and complication rates.
Clinical Applications
This guiding sheath is commonly used in neuro-interventional procedures such as embolization, aneurysm coiling, and other endovascular treatments. It is particularly beneficial in settings where radial artery access is preferred, such as outpatient clinics and specialized neuro-interventional suites. The device is suitable for adult patients requiring neurovascular interventions, especially those at higher risk for complications from femoral access.
Indications for Use
The FDA has cleared this device for use in embolization procedures involving coils. It is intended for patients requiring neuroendovascular interventions, particularly when a transradial approach is deemed appropriate.
Practical Considerations
The r2p destination slender guiding sheath is typically available in a 6 French size, which is standard for many neuro-interventional procedures. Clinicians should ensure compatibility with other devices used in the procedure and be familiar with the transradial technique to optimize outcomes.
Related Literature
A retrospective study evaluated the safety and feasibility of the 6Fr Terumo R2P Destination Slender Guiding Sheath in neuro-interventional procedures. Conducted at a single institution with 97 patients, the study found that the device was effective and safe for transradial neuro-interventions. However, as a retrospective study, it is limited by its design and the lack of a control group.
Frequently Asked Questions
What is r2p destination slender guiding sheath used for?
It is used for transradial neuroendovascular procedures, such as embolization and aneurysm coiling.
What specialties typically use this device?
Interventional radiologists and neuro-interventionalists commonly use this device.
What are the FDA-cleared indications?
The device is cleared for use in embolization procedures involving coils, particularly for neurovascular interventions.
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.