The Direxion™ Microcatheter, with its unique shaft design, offers you unrivaled torqueability for improved maneuverability. Further enhancing your ability to access challenging treatment sites are a variety of tip shapes that allow for flexibility and efficiency.
With Direxion’s best-in-class torque response and high-pressure flow rates, now with improved tip shapes and hydrophilic coating, you can reposition the microcatheter tip without a guidewire and obtain clear imaging with power injections up to 1200 psi.
Direxion™ Microcatheters can handle multiple acute turns at artery branches. This is made possible because each microcatheter has over 10,000 laser cuts through the nitinol shaft. Carefully calibrated spacing of these cuts allows us to offer the optimal stiffness profile—achieving a balance of pushability to advance the microcatheter with the softness needed to reach the most distal anatomy. With Direxion™, you’ll get the precision and control you need to get the procedure done.
Learn more by visiting the Direxion™ webpage.
Direxion™ and Direxion HI-FLO™ Torqueable Microcatheters
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, Con-traindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions
INTENDED USE/INDICATIONS FOR USE
The Direxion and Direxion HI-FLO Torqueable Microcatheters are intended for peripheral vascular use. The pre-loaded Fathom and Transend Guidewires can be used to selectively introduce and po-sition the microcatheter in the peripheral vasculature. The microcatheter can be used for con-trolled and selective infusion of diagnostic, embolic, or therapeutic materials into the vessel.
CONTRAINDICATIONS
None known.
WARNINGS
•Never advance or withdraw an intravascular device against resistance until the cause of resistance is determined by fluoroscopy. Movement of the microcatheter or guidewire against resistance may result in damage or separation of the microcatheter or guidewire tip, or vessel perforation.
•This Direxion Microcatheter family is not intended for use in the coronary vasculature or neuro-vasculature.
•The Direxion HI-FLO Microcatheter is not designed for the delivery of embolic coils.
•Use of excessive force to manipulate the microcatheter against resistance can cause a fracture in the nitinol shaft. Take care not to over-torque the microcatheter, and to relieve any tension before withdrawal by rotating the microcatheter in the opposite direction.
PRECAUTIONS
•This device should be used only by physicians thoroughly trained in percutaneous, intravascular techniques and procedures.
•Do not introduce the microcatheter without guidewire support as this may cause damage to the proximal shaft of the catheter.
•Because the microcatheter may be advanced into narrow sub-selective vasculature, repeatedly assure that the microcatheter has not been advanced so far as to interfere with its removal.
ADVERSE EVENTS
The Adverse Events include, but are not limited to:
•Allergic reaction
•Death
•Embolism
•Hemorrhage/Hematoma
•Infection
•Pseudoaneurysm
•Stroke
•Vascular thrombosis
•Vessel occlusion
•Vessel spasm
•Vessel trauma (dissection, perforation, rupture)
PI-553507-AA June 2018
