When the catheter is exposed to the vascular system, it should be manipulated while under high quality fluoroscopic observation. 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. Use of a pressure-monitoring device is recommended to prevent over pressurization. At least 99.9% of the balloons (with a 95% confidence) will not burst at or below their RBP. The RBP is based on results of in vitro testing. Never use air or any gaseous medium to inflate the balloon.īalloon pressure should not exceed the rated burst pressure (RBP). Use only the recommended balloon inflation medium. 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. Percutaneous transluminal coronary angioplasty (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. DO NOT resterilize and / or reuse it, as this can compromise device performance and increase the risk of cross contamination due to inappropriate reprocessing. ![]() This device is intended for one time use only. to treat coronary artery spasm in the absence of a significant stenosis.in an unprotected left main coronary artery.The NC TREK™ RX & OTW Coronary Dilatation Catheters are not intended to be used: All stents should be deployed in accordance with the manufacturer’s indications and instructions for use. NOTE: Post-deployment stent expansion testing was performed on the bench with the MULTI-LINK VISION™ and MULTI-LINK ULTRA™ Coronary Stents. It is strictly forbidden to make copies, whether partial or total and on whichever media without prior approval.The NC TREK™ RX & OTW Coronary Dilatation Catheters are indicated for:Ī) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusionī) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarctionĬ) balloon dilatation of a stent after implantation (balloon models 2.00 mm – 5.00 mm only)Īpplies to NC TREK™ OTW Coronary Dilatation Catheter Only: This Website is protected by the laws on copyright and by the relevant international conventions. Prior to use, please consult device labeling for prescriptive information and operating instructions. ![]() ![]() To the extent this site contains information, reference guides and databases intended for use by licensed medical professionals, such materials are not intended to offer professional medical advice. Please note that the following pages are exclusively reserved for health care professionals in countries with applicable health authority product registrations. For health care professionals in EUROPE excepted those practicing in France as the following pages are intended to all International health care professionals and are not in compliance with the French Advertising law N☂011-2012 dated 29th December 2011 article 34. Other health care professionals should select their country in the top right corner of the website.
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