R2P Slenguide

FDA-Cleared Indications

• Used to provide a pathway for the introduction and guidance of interventional devices during percutaneous vascular procedures.
• Used in endovascular procedures involving peripheral blood vessels when catheter guidance is required.
• FDA-cleared under product code DQY, Catheter, Percutaneous, under 21 CFR 870.1250.

Clinical Applications

• Guiding interventional devices during percutaneous peripheral vascular procedures.
• Providing catheter support during endovascular treatment of peripheral vascular disease.
• Facilitating delivery of a vascular stent when the anatomy and device compatibility are appropriate.
• Use through transradial access when a suitable access sheath and catheter length are selected.

Reported off-label uses

• Use as a guiding catheter for selected venous interventions, including venous stent delivery, when judged appropriate by the treating physician.
• Use in other complex endovascular procedures requiring long catheter support or access to difficult vascular anatomy.

Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.

Practical Considerations

• The provided product information describes compatibility with a 7-Fr Glidesheath Slender and use with a guiding catheter approximately 150 cm long; operators must confirm current manufacturer specifications before use.
• Select the catheter size, length, guidewire and accessory devices according to the target vessel, access route and intended intervention.
• Transradial use requires appropriate assessment of radial artery size, hand circulation and access-site risks.
• MRI safety should not be assumed from the FDA clearance record. Confirm the current labeling for MR Safe, MR Conditional or MR Unsafe status before MRI.
• Potential complications are those associated with percutaneous catheterization, including bleeding, hematoma, vessel injury, thrombosis, embolization, infection and contrast-related reactions.