Overview
Dr. Eric Carlson used Scoreflex® NC Scoring Balloon Catheters to successfully treat a 95% stenosed calcified lesion in the mid LAD.
Dr. Eric Carlson used Scoreflex® NC Scoring Balloon Catheters to successfully treat a 95% stenosed calcified lesion in the mid LAD.
70-year-old female with a history of hypertension, diabetes, and elevated cholesterol. Presented with increased shortness of breath. Echocardiogram revealed a reduced ejection fraction (30-35%) with anterior/inferior hypokinesis. Troponin levels elevated. After being transferred to the facility the patient suffered cardiac arrest. After stabilization the patient was brought to the Cardiac Cath lab for definitive angiography.
Right radial access was obtained (6 Fr). Diagnostic pictures were taken with a 6 Fr angiographic radial catheter and revealed a 95% calcified mid-LAD lesion.
A 6 Fr guide catheter was used for intervention of the LAD. A 0.014” guidewire was inserted, and the lesion was predilated with a 2.5 x 10 mm Scoreflex NC balloon at nominal pressure. IVUS was then performed revealing a moderately calcified lesion with a proximal reference vessel diameter of 4.0 mm. Additional vessel prep was performed with a 3.5 x 15 mm Scoreflex NC, and optimal expansion was achieved.
A 4.0 x 32 mm DES was then deployed and post-dilated with a 4.0 x 15 mm non-compliant balloon. A final IVUS run was performed showing good stent expansion and apposition.
Scoreflex® NC is distributed by CSI and Manufactured by OrbusNeich Medical Group Holdings Limited.
Caution: Federal law (USA) restricts the sale of these devices to sale by, or on the order of, a physician.
Scoreflex® NC is a registered trademark of OrbusNeich Medical Group Holdings Limited or its affiliates. G-70-1982. All other trademarks cited herein are owned by their respective owners.
Indications: The Scoreflex® NC Scoring PTCA Catheter is indicated for balloon dilatation of a de novo stenotic portion of a coronary artery in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion, in-stent restenosis.
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: 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 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.
Precautions: 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.
Results may vary.
Suggestions on case studies offered by the physician are based on their experience using Scoreflex® NC and are their opinion. Medical decisions for your patients are to be based upon their condition and your medical judgment. CSI does not recommend or endorse any particular course of treatment or medical choice. Before using any medical device, including those demonstrated or referenced in this case study, review all relevant Instructions for Use, with particular attention to the indications, contraindications, warnings and precautions, and steps for use of the device.