Joguide Cardiovascular Guiding C Atheter

FDA-Cleared Indications

• For percutaneous vascular procedures requiring catheter access and guidance.
• For guiding compatible interventional devices through the vascular system during catheter-based treatment.

Clinical Applications

• Providing catheter access and support during percutaneous vascular intervention.
• Guiding compatible balloons, stents, or other interventional devices to a target vessel.
• Supporting catheter-based treatment in the cardiovascular and peripheral vascular systems when the device size and configuration are appropriate.

Reported off-label uses

• Use as a general-purpose guiding catheter in vascular interventions outside the device-specific cleared labeling may occur in clinical practice, but this should be determined by the treating physician and institutional protocols.

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 catheter is available in different sizes and configurations; selection depends on the access route, target vessel, anatomy, and other devices being used.
• It is intended to be used with compatible guidewires, balloons, stents, and other interventional equipment according to the product instructions.
• Insertion and positioning require fluoroscopic or other appropriate imaging guidance by trained clinicians.
• MRI safety depends on the specific catheter model and its materials; the product labeling should be reviewed before an MRI examination.
• Potential risks include bleeding, hematoma, infection, vessel injury, thrombosis, embolization, dissection, perforation, arrhythmia, and catheter malfunction.