As you pursue new and innovative procedures within more complex anatomy, you need precision and control like never before. Fathom Steerable Guidewires feature a nitinol hypotube distal segment—a design that revolutionizes the ability to access even the most tortuous vascular beds. Diamond-cutting the nitinol hypotube and creating an alternating pattern of microscopic channels helps transmit turn-for-turn torque control that enhances responsiveness and maneuverability. The platinum-tungsten distal tip is shapeable and is engineered to achieve accurate placement while maintaining tip-shape memory. For more information, visit our Fathom™ Steerable Guidewires page.
Indications, Safety and Warnings
Prescriptive Information
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions
FATHOM -14 Steerable Guidewire
INTENDED USE/INDICATIONS FOR USE
The FATHOM -14 Steerable Guidewire is intended for general intravascular use in the peripheral vasculature. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral vasculature. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.
Fathom-16 Steerable Guidewire
INTENDED USE/INDICATIONS FOR USE
The FATHOM -16 Steerable Guidewire is intended for general intravascular use in the peripheral vasculature. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral vasculature. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.
Fathom -14 and -16 Steerable Guidewire Contractions, Warnings and Adverse Events
CONTRAINDICATIONS
None known.
WARNINGS
The FATHOM Steerable Guidewire is not intended for use in the coronary vasculature or the neuro vasculature.
ADVERSE EVENTS
Complications attributed to endovascular procedures are the following:
• Vessel trauma
• Vessel damage
• Embolism (catheter/device, air bubble, plaque, thrombus, air embolism, thromboembolism)
• Pseudoaneurysm
• Seizure/stroke
• Vessel dissection
• Hematoma at the puncture site
• Nerve injury
• Infection
• Perforation of the vessel
• Vessel spasm
• Hemorrhage
• Vascular thrombosis
• Vessel occlusion
• Death
• Bleeding
• Failed treatment
• Inability to position guidewire
• Damage to the catheter
