Delivers a broad size matrix, excellent pushability and exceptional balloon performance for challenging anatomy.
Designed with smooth transitions for challenging anatomy.
Focused force angioplasty for non-compliant plaque modification and lesion preparation.
Data on file at Abbott.
Manufactured by OrbusNeich Medical Group Holdings Limited or its affiliates, distributed by CSI Cardiovascular Systems, Inc. CSI is a subsidiary of the Abbott Group of Companies.
‡Scoreflex and OrbusNeich are registered trademarks of OrbusNeich Medical Group Holdings Limited or its affiliates.
MAT-2115065 v4.0
CAREFULLY READ ALL INSTRUCTIONS PRIOR TO USE. OBSERVE ALL WARNINGS AND PRECAUTIONS NOTED THROUGHOUT THESE INSTRUCTIONS. FAILURE TO DO SO MAY RESULT IN COMPLICATIONS.
Applies to TREK™ RX & OTW 2.25 mm – 5.00 mm sizes only:
The TREK™ RX & OTW Coronary Dilatation Catheters are indicated for:
Applies to MINI TREK™ RX and MINI TREK™ II OTW
1.50 mm – 2.00 mm sizes only:
The TREK™ RX & OTW Coronary Dilatation Catheters are indicated for:
Applies to MINI TREK™ RX and MINI TREK™ II OTW 1.20 mm sizes only:
The MINI TREK™ RX and MINI TREK™ II OTW 1.20mm Coronary Dilatation Catheters are indicated for:
Note (applies to 2.00 mm to 5.00 mm only): Post-deployment stent expansion testing was performed on the bench with the MULTI-LINK VISION™ and MULTI-LINK ULTRA™ stents. All stents should be deployed in accordance with the manufacturer’s indications and instructions for use.
The TREK™ RX & OTW, MINI TREK™ RX and MINI TREK™ II OTW Coronary Dilatation Catheters are not intended to be used to treat patients with:
This device is intended for one time use only. DO NOT resterilize and / or reuse it, as this can compromise device performance and increase the risk of cross contamination due to inappropriate reprocessing.
Percutaneous transluminal coronary angioplasty (PTCA) should only be performed at hospitals where emergency coronary artery bypass graft surgery can bequickly performed in the event of a potentially injurious or life-threatening complication.
PTCA in patients who are not acceptable candidates for coronary artery bypass graft surgery requires careful consideration, including possible hemodynamic support during PTCA, as treatment of this patient population carries special risk.
Use only the recommended balloon inflation medium. Never use air or any gaseous medium to inflate the balloon.
Balloon pressure should not exceed the rated burst pressure (RBP). The RBP is based on results of in vitro testing. At least 99.9% of the balloons (with a 95% confidence) will not burst at or below their RBP. Use of a pressure-monitoring device is recommended to prevent overpressurization.
To reduce the potential for vessel damage, the inflated diameter of the balloon should approximate the diameter of the vessel just proximal and distal to the stenosis.
When the catheter is exposed to the vascular system, it should be manipulated while under high quality fluoroscopic observation. Do not advance or retract the catheter unless the balloon is fully deflated under vacuum. If resistance is met during manipulation, determine the cause of the resistance before proceeding.
Do not use, or attempt to straighten, a catheter if the shaft has become bent or kinked; this may result in the shaft breaking. Instead, prepare a new catheter.
Do not torque the catheter more than one (1) full turn.
Treatment of moderately or heavily calcified lesions is considered to be moderate risk, with an expected success rate of 60 – 85% and increases the risk of acute closure, vessel trauma, balloon burst, balloon entrapment, and associated complications. If resistance is felt, determine the cause before proceeding. Continuing to advance or retract the catheter while under resistance may result in damage to the vessels and / or damage / separation of the catheter.
In the event of catheter damage / separation, recovery of any portion should be performed based on physician determination of individual patient condition and appropriate retrieval protocol.
Note the “Use by” date specified on the package.
Inspect all product prior to use. Do not use if the package is open or damaged.
This device should be used only by physicians trained in angiography and PTCA, and / or percutaneous transluminal angioplasty (PTA).
Prior to angioplasty, the dilatation catheter should be examined to verify functionality and ensure that its size is suitable for the specific procedure for which it is to be used.
During the procedure, appropriate anticoagulant and coronary vasodilator therapy must be provided to the patient as needed. Anticoagulant therapy should be continued for a period of time to be determined by the physician after the procedure.
If the surface of the TREK™ RX & OTW, MINI TREK™ RX or MINI TREK™ II OTW Coronary Dilatation Catheter becomes dry, wetting with heparinized normal saline will reactivate the coating.
Do not reinsert the TREK™ RX & OTW, MINI TREK™ RX or MINI TREK™ II OTW Coronary Dilatation Catheter into the coil dispenser after procedural use.
The safety and effectiveness of this PTCA balloon catheter for the treatment of in-stent restenosis (ISR) have not been established.
Applies to TREK™ RX and MINI TREK™ RX only (APPLIES TO ALL SIZES), in addition to above:
The design and construction of these catheters do not provide the user with distal pressure monitoring capability.
Applies to TREK™ RX 4.50mm and5.00mm sizes only, in addition to above:
With 4.5 mm and 5.0 mm balloon dilatation catheters, some increased resistance may be noted upon insertion or withdrawal into or out of the guiding catheter. Choosing a larger guiding catheter size may minimize this.
Applies to TREK™ OTW and MINI TREK™ II OTW (APPLIES TO ALL SIZES), in addition to above:
Bench testing was conducted with 0.014” (.36mm) constant diameter guide wires to establish guide wire compatibility. If another type of guide wire is selected with a different dimensional profile, the compatibility (e.g., wire resistance) should be considered prior to use.
Possible adverse effects include, but are not limited to, the following:
MAT-2109405 2.0
The NC TREK NEO™ Coronary Dilatation Catheters are indicated for:
a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion
b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction
c) balloon dilatation of a stent after implantation (balloon models 2.00 mm – 5.00 mm only)
The NC TREK NEO™ Coronary Dilatation Catheter is contraindicated for treatment of the unprotected left main coronary artery and for coronary artery spasm in the absence of a significant stenosis
This device is intended for one time use only. DO NOT resterilize and / or reuse it, as this can compromise device performance and increase the risk of cross contamination due to inappropriate reprocessing.
Note the “Use by” date specified on the package.
The outside diameter (OD) of the distal 38 cm of the device, including the distal shaft, tip, and the balloon are coated with HYDROCOAT™ Hydrophilic Coating. Refer to PREPARATIONS FOR USE section of these instructions for further information on how to prepare and use this device to ensure it performs as intended. Failure to abide by the warnings in this labeling might result in damage to the device coating, which may necessitate intervention or result in serious adverse events.
Percutaneous transluminal coronary angioplasty (PTCA) should only be performed at centers where emergency coronary artery bypass graft surgery is available.
PTCA in patients who are not acceptable candidates for coronary artery bypass graft surgery requires careful consideration, including possible hemodynamic support during PTCA, as treatment of this patient population carries special risk.
Persons with known history of allergies to any of the components of this device listed below may suffer an allergic reaction to this coronary dilatation catheter. Prior to its use on the patient, the patient should be counseled on the materials contained in the device, and a thorough history of allergies must be discussed. This device contains: polyethylene oxide coating, polyamide, polyether block amide (PEBAX), polyethylene and stainless steel.
Use only the appropriate balloon inflation media. Do not use air or any gaseous medium to inflate the balloon. If gaseous medium is used and balloon rupture occurs there is a potential of causing air embolism and / or vessel injury. Balloon pressure should not exceed the rated burst pressure (RBP). Use of a pressure-monitoring device is recommended to prevent over pressurization.
To reduce the potential for vessel damage, the inflated diameter of the balloon should approximate the diameter of the normal or undiseased vessel segment, just proximal and distal to the stenosis.
Do not use or attempt to straighten a catheter if the shaft has become bent or kinked; this may result in the shaft breaking. Instead, prepare a new catheter.
Treatment of moderately or heavily calcified lesions is considered to be moderate risk, with increase in the risk of acute closure, vessel trauma, balloon burst, balloon entrapment, and associated complications. If resistance is felt, determine the cause before proceeding.
Continuing to advance or retract the catheter while under resistance may result in damage to the vessels and / or damage / separation of the catheter.
When the catheter is exposed to the vascular system, it should be manipulated while under high quality fluoroscopic observation. Do not advance or retract the catheter unless the balloon is fully deflated under vacuum. If resistance is met during manipulation, determine the cause of the resistance before proceeding.
Do not torque the catheter more than one (1) full turn.
In the event of catheter damage / separation, retrieval methods (use of additional wires, snares, and / or forceps) may result in additional trauma to the coronary vasculature and / or the vascular access site. Complications may include bleeding, hematoma, or pseudoaneurysm.
To confirm sterility has been maintained, ensure that the package sterile barrier has not been opened or damaged prior to use. Inspect all product and ensure that the device is not damaged. Care must be taken to properly size the balloon prior to use.
During the procedure, appropriate anticoagulant and coronary vasodilator therapy must be provided to the patient as needed. Anticoagulant therapy should be continued for a period of time as determined by the physician after the procedure.
If the surface of the coronary dilatation catheter becomes dry, wet with heparinized normal saline to reactivate the coating.
Do not reinsert the coronary dilatation catheter into the coil dispenser after procedural use
The safety and effectiveness of these devices have not been established, or is unknown, in vascular regions other than those specifically indicated:
Possible adverse effects include, but are not limited to, the following:
MAT-2206959 v3.0
INDICATIONS
The Scoreflex‡ NC Scoring PTCA Catheter is indicated for: Balloon dilatation of a de novo stenotic portion of a coronary artery and in-stent restenosis in coronary arteries in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion.
CONTRAINDICATIONS
The use of the Scoreflex‡ NC Scoring PTCA Catheter is contraindicated in the following patient types:
WARNINGS
When using this type of device, the following warnings should be observed:
PRECAUTIONS
ADVERSE EVENTS
Adverse events that may be associated with the use of this product include, but are not limited to, the following:
Scoreflex‡ NC Scoring PTCA Catheter is manufactured by OrbusNeich Medical Group Holdings Limited or its affiliates and distributed by Cardiovascular Systems, Inc. (CSI). CSI is a subsidiary of the Abbott Group of Companies.
MAT-2303959 v1.0
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