CLINICALLY PROVEN
CTO CROSSING CATHETER

CAUTION: This device is restricted to use by or on the order of a physician. Refer to the Instructions for Use for a complete listing of the Indications, Contraindications, Warnings, Precautions, Adverse Events, and Procedural Steps.

Indications for Use

The Wingman CTO Crossing Catheter is intended to treat peripheral artery disease (PAD) and chronic total occlusions (CTO).

Intended Use

The Wingman CTO Crossing Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the peripheral vasculature and to penetrate and recanalize a lesion intraluminal or subintimal using the extendable needle tip with the activating handle. It may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for delivery of saline solutions or diagnostic contrast.

Contraindications

The Wingman 14, 14C, 18, and 35 Crossing Catheters are contraindicated for use in the coronary and cerebral vasculature.

Warnings

• Hydrophilic wires prone to excessive swelling (e.g. ZipWire) should not be used with the Wingman CTO Crossing Catheter.
• Single Use only. Do not reuse/resterilize. Reusing the device could result in compromised device performance, cross-infection and other safety related hazards including patient injury.
• Do not use if device is open or packaging is damaged
• Never advance, withdraw or rotate the Wingman CTO Crossing Catheter against resistance until the cause is determined by fluoroscopy.
• DO NOT turn the handle more than 90 degrees during advancement of the extendable needle tip. The tip will not advance further by turning more than 90 degrees; continuing to rotate the handle beyond 90 degrees may lead to device breakage.
• This device contains nickel and should not be used in patients with known allergies to nickel.
• If the catheter is damaged, this product may cut into a blood vessel wall. Extreme caution needs to be taken when removing a damaged device.
• In the case of complications resulting from the removal of the entire system, stop immediately the procedure, and perform appropriate treatment at the discretion of the physician.
• This device contains cobalt and should not be used in patients with known allergies to cobalt.

Precautions

• Store in a cool, dry, dark place. Storage of the device in extreme conditions may damage the device and/or affect device performance that could lead to patient injury.
• Use only appropriately sized ancillary device, as shown in the Specifications above.
• Maximum Injection pressure: 360 psi (2482kpa).
• Use the catheter prior to the “Use By” date specified on the package.
• The catheter should only be used by physicians qualified to perform percutaneous vascular interventions.
• Precautions to prevent or reduce clotting should be taken when any catheter is used in the vascular system. Use of systemic heparinization and heparinized saline solution should be considered.
• Exercise care while handling the catheter during procedure to reduce the possibly of accidental damage, kinking or bending.
• Manipulation of the catheter should only occur under fluoroscopy.

©2026 Reflow Medical, Inc. All rights reserved. Reflow Medical, Wingman and The Pulse of Medical Ingenuity are registered trademarks or trademarks of Reflow Medical, Inc. This device is restricted to use by or on the order of a physician. Refer to the Instructions for Use for a complete listing of the Indications, Contraindications, Warnings, Precautions, Adverse Events, and Procedural Steps.