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r2p slenguide
Ashitaka Factory Of Terumo
Summary: The r2p slenguide is a guiding catheter used in endovascular procedures, particularly for venous stenting. It is typically used by interventional cardiologists and radiologists.
FDA Clearance Information
Pathway
510K
Number
K161546 ↗
Decision Date
October 14, 2016
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The r2p slenguide was cleared through the FDA 510k pathway on October 14, 2016. It is manufactured by Ashitaka Factory Of Terumo and classified as a Class 2 device.
What It Is
The r2p slenguide is a guiding catheter designed for use in endovascular procedures. It features a long shaft and rapid-exchange system, which facilitates the placement of stents in peripheral arteries via transradial access. This design allows for improved maneuverability and access to difficult-to-reach vascular sites.
Clinical Applications
The r2p slenguide is commonly used in procedures involving the placement of venous stents, particularly in the superficial femoral artery. It is utilized in settings such as catheterization labs by interventional cardiologists and radiologists. The device is beneficial for patients requiring minimally invasive vascular interventions, especially those with peripheral artery disease.
Indications for Use
The r2p slenguide is indicated for use in guiding stents to treat narrowed or blocked peripheral arteries. It is particularly useful for patients with conditions like critical limb ischemia, where restoring blood flow is essential.
Practical Considerations
The r2p slenguide is compatible with a 7-Fr Glidesheath Slender and is typically used with a 150-cm-long guiding catheter. Clinicians should be familiar with transradial access techniques and ensure compatibility with other procedural equipment.
Related Literature
The linked study reports the first human use of the R2P system, including the r2p slenguide, in a 73-year-old male with critical limb ischemia. The study demonstrated successful stenting of the left superficial femoral artery via radial access. Key findings include the device's effectiveness in transradial stenting, though the study is limited by its single-patient scope.
Frequently Asked Questions
What is r2p slenguide used for?
The r2p slenguide is used for guiding stents in endovascular procedures, particularly in peripheral arteries.
What specialties typically use this device?
Interventional cardiologists and radiologists typically use this device.
What are the FDA-cleared indications?
The r2p slenguide is indicated for use in guiding stents to treat narrowed or blocked peripheral arteries.
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.