Medtronic Sherpa Guiding Catheter

FDA-Cleared Indications

• Used to facilitate the placement and guidance of other interventional devices within the vascular system.
• Intended for percutaneous vascular procedures in which catheter support or a conduit is needed.

Clinical Applications

• Providing access and support for other devices during percutaneous vascular interventions.
• Supporting catheter-based treatment of vascular disease when additional interventional devices must be advanced to a target vessel.
• Use in image-guided procedures performed in cardiac catheterization laboratories or interventional radiology suites.

Reported off-label uses

• Use as a support catheter for selected complex endovascular procedures beyond the specific configurations or applications described in the device labeling may occur in clinical practice. Such use depends on physician judgment and institutional policy.

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

• Select catheter size, length, tip shape and support characteristics according to the access vessel, target anatomy and other devices being used.
• Confirm compatibility with guidewires, sheaths and interventional devices before use; compatibility can vary by catheter model and size.
• Advance and withdraw the catheter under appropriate fluoroscopic or other imaging guidance. Do not force it if resistance is encountered.
• Review the current product instructions for use for contraindications, warnings, storage requirements and device-specific MRI information; MRI safety should not be assumed from the FDA product code alone.
• Potential risks of catheter-based vascular procedures include bleeding, hematoma, vessel injury, dissection, perforation, thrombosis, embolization, infection, contrast reaction and loss of vessel access.