Prowler Select 10 and 14 Infusion Catheters with and Without Pre-Shaped TIPS

FDA-Cleared Indications

• Delivery of therapeutic agents within the neurovascular system.
• Use during neurovascular procedures requiring selective catheter placement and infusion of a therapeutic agent.

Clinical Applications

• Selective delivery of medications during neurovascular procedures.
• Delivery of embolic agents when appropriate for the labeled catheter and procedure.
• Catheter-based treatment of cerebrovascular lesions requiring targeted infusion, when consistent with the device labeling.
• Use with compatible guidewires and related neurovascular equipment in hospital or specialty procedural settings.

Reported off-label uses

• Use as a delivery catheter for agents or procedures not specifically identified in the device labeling may occur in clinical practice, but this should be considered off-label and evaluated by the treating physician.

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 device is available in size 10 and size 14 configurations, with versions that have pre-shaped tips and versions without pre-shaped tips.
• Use only with compatible guidewires, connectors, infusion equipment, therapeutic agents and embolic materials according to the current instructions for use.
• The operator should confirm that the catheter size, tip configuration and length are appropriate for the target vessel and access route.
• As with other neurovascular catheters, risks include vessel injury, dissection, perforation, vasospasm, thromboembolism, infection and bleeding.
• MRI safety and conditional-use information must be confirmed in the current manufacturer labeling; do not assume that the catheter is safe for MRI while it is in place.