Established options for access

Shapeable / reshapeable tip

Transend Guidewires' design utilizes a 2cm, tapered-ribbon corewire tip, engineered to permit repeated tip shaping and reshaping

Scitanium Corewire Designed for Access

Transend corewires are engineered to enhance torque transmission and distal support allowing orientation of formed tip for precise vessel selection and positioning

ICE - Hydrophilic Distal Selection

ICE is a lubricious coating on the 39cm distal segment (distal 61cm in Transend .010) which is intended to facilitate advancement of the guidewire within the microcatheter and tortuous neurovasculature

INTENDED USE/Indications for use

The Transend 300 ES guidewire and Transend 300 Floppy guidewire are intended for general intravascular use, including the neuro and peripheral vasculature. The guidewires can be torqued to facilitate the selective placement of diagnostic or therapeutic catheters. These devices are not intended for use in coronary arteries. A torque device (pin vise) is included with the guidewire to facilitate directional manipulation of the guidewire.

Precautions

• This device should be used by physicians thoroughly trained in percutaneous, intravascular techniques and procedures.

• The Boston Scientific guidewire, the guidewire insertion tool, and the torque device are supplied STERILE and non-pyrogenic in unopened, undamaged packages. Verify that the sterility of the device has not been compromised by assuring package integrity has been maintained.

• If the integrity of the packaging has been compromised, do not use or attempt to resterilize. Contact your local Boston Scientific representative.

• Prior to a procedure, all equipment to be used for the procedure should be carefully examined to verify proper function and integrity.

• The outer diameter may reach up to 0.0145 in (0.37 mm) on the Transend 300 guidewire family

• Use a standard microcatheter and appropriate guiding catheter with either Transend 300 cm guidewire. Recommended guiding catheter specifications include a 90 cm length and a minimum ID of 0.050 in (1.27 mm).

• Check labeled diameter of diagnostic or therapeutic catheter and verify compatibility with the guidewire outer diameter prior to use.

• Due to the variations of certain catheter tip inner diameters, abrasion of the hydrophilic coating may occur during manipulation. If any resistance is felt during introduction of the catheter, use of a different catheter may be warranted.

• Inspect guidewire prior to use for any surface irregularities and bends or kinks. Damaged and/or irregular guidewires should not be used.

• Exercise care in handling a guidewire during a procedure to reduce the possibility of accidental breakage, bending or kinking.

• To avoid guidewire damage and possible shearing of plastic, do not withdraw or manipulate the guidewire through a metal needle cannula

Vessel trauma may result from the improper use of this device. Follow the instructions for use carefully. When the guidewire is in the body, it should be manipulated only under fluoroscopy. Do not attempt to move the wire without observing the resultant tip response. Do not leave the wire in a prolapsed condition, as damage to the wire may occur. Never advance the guidewire against excessive resistance without first determining the reason for resistance under fluoroscopy. Excessive force against resistance may result in separation of the guidewire tip, damage to the catheter and/or vessel perforation. Potential adverse events associated with endovascular procedures (including guidewire usage in the neuro and peripheral vasculature) include but are not limited to:

• Aneurysm rupture

• Access site complications including infection, hematoma and nerve injury

• Cerebral ischemia

• Death

• Embolism (catheter/device, air bubble, plaque, thrombus or char)

• Intracerebral/intracranial hemorrhage

• Pseudoaneurysm

• Seizure

• Stroke

• Transient ischemia attack

• Vasospasm

• Vessel perforation, dissection, trauma or damage