Scoreflex^‡ NC

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:

• Patients with an unprotected left main coronary artery.
• Patients with coronary artery spasm in the absence of a significant stenosis.

WARNINGS

When using this type of device, the following warnings should be observed:

• This device is intended for single use only. Do not resterilize and/or reuse, as this can potentially result in compromised device performance and increased risk of cross-contamination.
• This balloon is not intended for the expansion or delivery of a stent.
• PTCA in patients who are not acceptable candidates for coronary artery bypass graft surgery require careful consideration, including possible hemodynamic support during PTCA, as treatment of this patient population carries special risk.
• 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. Applying excessive force to the catheter can result in tip or catheter breakage, catheter kink, or balloon separation.
• Do not twist the catheter shaft in excess of 180 degrees when the tip is constrained.
• Balloon pressure should not exceed the rated burst pressure (RBP) indicated on the package. The rated burst pressure is based on the results of in vitro testing. At least 99.9 percent of the balloons, (with a 95 percent confidence) will not burst at or below their rated burst pressure. Use of a pressure monitoring device is recommended to prevent over pressurization.
• To reduce the potential for air embolus into the vessel, use only the recommended balloon inflation medium. Never use air or any gaseous medium to inflate the balloon.
• Do not re-straighten a kinked hypotube; straightening a kinked metal shaft may result in breakage of the shaft.
• PTCA should only be performed at hospitals where emergency coronary artery bypass graft surgery can be quickly performed in the event of a potentially injurious or life-threatening complication.

PRECAUTIONS

• Use the catheter prior to the “Use By” date specified on the package.
• Prior to angioplasty, the catheter should be examined to verify functionality and ensure that its size and shape are suitable for the specific procedure for which it is to be used.
• The catheter system should be used only by physicians trained in percutaneous transluminal coronary angioplasty.
• During the procedure, appropriate anticoagulant and coronary vasodilator therapy must be provided to the patient as needed. After the procedure, anticoagulant therapy should be continued for a period of time as determined by the physician.
• Never advance the Scoreflex^‡ NC Scoring PTCA Catheter without the guidewire extending from the tip.
• Do not use oil-based contrast medium, organic solvents, or alcohols; there is a possibility of catheter leak, damage, or lubrication loss.
• The balloon deflation time has been established as 15 seconds based on in vitro bench testing results.
• Do not reinsert the PTCA catheter into the coil dispenser after procedural use.
• Discard all disposable devices used during this procedure per local requirements for medical device waste disposal.

ADVERSE EVENTS

Adverse events that may be associated with the use of this product include, but are not limited to, the following:

• Death
• Acute myocardial infarction
• Total occlusion of the coronary artery
• Coronary vessel dissection, perforation, rupture, or injury
• Acute vessel closure
• Restenosis of the dilated vessel
• Unstable angina
• Stroke, air embolism and embolization of fragmentation of thrombotic or atherosclerotic material
• Arrhythmias, including ventricular fibrillation
• Hypertension
• Hypotension
• Coronary artery spasm
• Hemorrhage or hematoma
• Arteriovenous fistula
• Drug reactions, allergic reaction to contrast medium
• Infection
• Need for blood transfusion

CAUTION: This product is intended for use by or under the direction of a physician. Prior to use, reference the Instructions for Use, inside the product carton (when available), at manuals.eifu.abbott or at eifu.orbusneich.com for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events. This material is intended for use with healthcare professionals only.

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.