ABBOTT OTW BALLLOON

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Important Safety InformationTop Of Page
Nc Trek Rx & Otw Coronary Dilatation CathetersIndicationsThe Nc Trek Rx & Otw 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)
Applies To Nc Trek Otw Only:Note: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.
ContraindicationsThe Nc Trek Rx & Otw Coronary Dilatation Catheters Are Not Intended To Be Used:
In An Unprotected Left Main Coronary Artery;To Treat Coronary Artery Spasm In The Absence Of A Significant Stenosis.WarningsThis 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 Be Quickly 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 Over Pressurization.
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.

Additional Information: