SIMPLE & EFFECTIVE
Expanded indication to Cross Chronic Total
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the Wingman™
Compatible with the physician’s choice of guidewire. Works with the Reflow Spex™ and SpexLP™ catheters for added support in lesion crossing.
RAPID, ROUTINE LESION CROSSING “ON-THE-FLY”
- Compatible with physician-preferred guidewire and procedural technique.
- Keeps the physician in control of the device advancement and activation at all times.
- Provides a similar safety profile to conventional support catheters.
- Eliminates the need for expensive, complicated energy devices to cross most lesions.
- .014”, .018” and .035” options allow treatment of a broad range of vasculature: SFA, iliac and below-the-knee.
- Reduces total procedure time.
BRAID-REINFORCED
HYPOTUBE MICROCATHETER
Provides added column strength and traction to resist kinks
CONTROL POINT™
ACTIVATION AND
ENGAGEMENT HANDLE
Allows you to simultaneously “push and twist” the beveled tip to anchor and penetrate the lesion
UNIQUE EXTENDABLE
BEVELED TIP
Improves tracking through extremely tight occlusions and difficult-to-cross vasculature
CONTROL COAT™
HYDROPHILIC
CATHETER COATING
Increases lubricity without compromising tactile feedback
14
14C
18
35
Model Number – Effective Length
WGM14065CE – 65 cm
WGM14135CE – 135 cm
WGM14150CE – 150 cm
WMC14090CE – 90 cm
WMC14135CE – 135 cm
WMC14150CE – 150 cm
WGM18090CE – 90 cm
WGM18135CE – 135 cm
WGM18150CE – 150 cm
WGM35065CE – 65 cm
WGM35090CE – 90 cm
WGM35135CE – 135 cm
Effective Length (cm)
65,135,150
90, 135,150
90,135,150
65,90,135
Introducer Sheath Compatibility (F)
4
4
4
5
Max Outer Diameter (in/F)
0.035/2.7
0.035/2.7
0.050/3.8
0.06/4.6
Max Pressure (psi/kpa)
360/2482
360/2482
360/2482
360/2482
Extendable Tip Diameter (in/mm)
0.022/0.56
0.024/.61
0.032/0.81
0.050/1.27
Tip Extension (in/mm)
0.20/5
0.20/5
0.20/5
0.20/5
Hydrophilic Coating (cm)
N/A
30
30
40
©2024 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.
Indications, Safety, & Warnings
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.
Intended Use
The Wingman CTO Crossing Catheter is intended to treat peripheral artery disease (PAD) and chronic total occlusions (CTO).
Indications for 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.
• The guidewire should always stay within the catheter as this can cause damage to it.
• 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.
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.
©2024 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.
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