Scoreflex NC

Scoring PTCA Catheter

Focused Force Angioplasty for Non-Compliant Plaque Modification and Lesion Preparation

  • First: Non-Compliant Scoring Balloon in the U.S.
  • Highest: Rated Burst Pressure in the U.S.
  • Low: Crossing Profile
  • Indicated for In-Stent Restenosis

Focused Force Angioplasty for Safe and Controlled Dilatation1,2

Scoreflex NC Scoring PTCA Catheter is a focused force dilatation balloon with a dual-wire system which creates a focal stress pattern to facilitate safe and controlled plaque modification at lower resolutions pressure.3

Scoreflex Focused Force

Non-Compliant Plaque Modification and Lesion Preparation

Scoreflex Diagram

Unique Catheter Design for Dual-Wire Scoring

Short rapid exchange tip facilitates the combined effect of the built-in nitinol integral wire and the conventional guidewire to score lesions.

Non-Compliant Balloon for Safety and Accuracy

Proprietary nylon formulation controls the balloon growth and achieves high-rated burst pressure.

Catheter Designed for Excellent Deliverability

Low crossing profile and continuous hub-to-tip metal construction for optimal pushability.

Lubricious Coating for Enhanced Trackability

Hydrophilic coating on tip and distal shaft and hydrophobic coating in the guidewire lumen provide smooth trackability.

Technical Drawing

Scoreflex Legend

MAT-2401611 v1.0

References

Data on file at Abbott.

  1. Kawase Y, et al. Cardiovasc Interv Ther. 2014;29(2):134-9.
  2. Kandzari D, et al. Cardiovasc Revasc Med. 2022;35:85-90.
  3. Solar RJ, Ischinger TA. Cardiovasc Radiat Med. 2003;4(1):47-50.

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.

 

Important Safety Information
 

Scoreflex NC Scoring PTCA Catheter

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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


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