BARD LATEX FOLEY CATHETERS Utilization Insertion Maintenance Duration Together, advancing the world of health
LATEX ALLERGIES ARE NOT NEW Approximately 1% of the U.S. population is estimated to be at risk 1 MILD REACTIONS MODERATE SEVERE 2
A HUNT FOR ALTERNATIVE MATERIALS GLOVES: NITRILE LATEX POLYETHYLENE VINYL Yet, Bard s Foley s Sales are still predominantly latex. 3 3% Silicone 7% Latex Percentage of Bard Foley catheters in trays by material 4 WHY?
MATERIAL DIFFERENCES Latex Ultimate Tensile Strength 5 : 1.3 21.1 MPa Silicone Ultimate Tensile Strength 5 : 6 8.3 MPa Elongation at Break 5 : 33 5% Elongation at Break 5 : 17 45% Critical Surface Tension 6 : 32 dynes/cm Critical Surface Tension 6 : 24 dynes/cm. Dynes/cm is a unit measurement of torque. MPa is a derived unit of pressure. Data presented on this page are not specific to Foley catheters.
ENGINEERED FOR PERFORMANCE Smooth tip Large drainage eyes Latex Foley Secure balloon design Surface processed for optimal bonding Low coefficient of friction Robust drainage funnel & accessible inflation port
ADVANCED TIP Smooth to mitigate tissue trauma Reinforced to facilitate safe use of a stylet or guide Bardex Foley catheter tip 1% silicone catheter tip.4 Average Flashing from Tip (mm)* n=1.3.2.1 -.1 Covidien Dover 1% Silicone Covidien Dover Silver Silicone Bardex Data is based on bench study.
LARGER DRAINAGE EYES Designed to maximize drainage and minimize occlusion Smooth to help minimize tissue trauma Bardex Foley catheter 25 Average Eyelet Area (mm 2 )* n=1 2 15 1 5 Medline SilverTouch Medline Silicone Elastomer 1% Silicone Silver Silicone Bardex Foley Data is based on bench study. Results may not correlate to human use.
OPTIMAL BALLOON DESIGN Scan the QR code with your mobile to watch a demo of the test below. Bardex Foley Balloon Download the i-nigma QR code reader app from the App store for Free. Designed to Facilitate Optimal Seating Within the Bladder Neck and Help Reduce Risk of Balloon-burst* 15 Balloon fill volume at burst* n=1 1 5 Medline SilverTouch Medline Silicone Elastomer 1% Silicone Silver Silicone Bardex Foley Data is based on bench study. Results may not correlate to human use.
7 Ensures Water Retention to Mitigate Dislodgement* Water remaining in balloon after 29 days* n=1 Scan the QR code with your mobile to watch a demo of the test on the left. 6 5 4 3 2 1 Medline SilverTouch Medline Silicone Elastomer 1% Silicone Silver Silicone Bardex Foley Download the i-nigma QR code reader app from the App store for Free. 15% Designed to Mitigate Cuffing (and Trauma) Upon Deflation and Removal* % of balloons cuffed after 14 days* n=37 1% 5% % -5% Medline SilverTouch Medline Silicone Elastomer 1% Silicone Silver Silicone Bardex Foley Data is based on bench study. Results may not correlate to human use.
PROPRIETARY HYDROGEL COATING Permanently Bonded Coating Remains Intact While Indwelling in the Patient Allows for non-abrasive insertion and removal Provides a lubricious surface that resists bacterial adherence Prevents Bacterial Adherence and Encrustation Less bacterial adherence reduces the risk of biofilm formation the cause of antibiotic resistant infections Coefficient of Friction (COF)*.3.25.2.15 1 5 COF after 1 days in artificial urine n=1 Medline SilverTouch Medline Silicone Elastomer 1% Silicone Silver Silicone Bardex Foley Outside Surface (in Serum) Inside Surface (in Urine) 7 Bacteria Silicone Bard Coated Latex Silicone Bard Coated Latex E. Coli 1.3 +/-.5 91.5 +/-4.473 Pseudomonas f. 7.3 +/-.9 S. aureus 5.9 +/-1.9 68.4 +/-3.8 Klebsiella 1.9 +/-1. 25.9 +/-3.3 S. epidermiolis 185.1 +/-9.1 Proteus m. 6.7 +/-1.2 21.1 +/-2.5 Serratta 65.1 +/-3.5 79.2 +/-4.4 Proteus m. (G114) 135.7 +/-4.8 14.1 +/-2.6 Data provided on this page is supported by in vitro testing. Data is based on bench study. Results may not correlate to human use.
ENGINEERED FOR PATIENT SAFETY There Have Been No Confirmed Latex Allergic Reactions to Bard s Foley s. 8 Latex proteins are removed in each step of the manufacturing process of Bard s Latex Foley catheters. µg/g 35 3 25 2 15 1 5 NRL Extractable Protein 9 6 5 4 3 2 1 µg/g ASTM D6499-3 Sample #: 1 - After dipping and an initial oven cure 2 - After stripping from the dipping wires and an additional oven curing 3 - After over night water leaching 4 - After chlorination 5 - After silver-alloy application 6 - After lubricious coating application 1 2 3 4 5 6 Latex Foley manufacturing process step ASTM D5712-99 ASTM D5712-99 ASTM D5712-99 NRL proteins below the threshold of detectability Protein Concentration (µg/g) Evaluation of Allergen Content in Latex s per ASTM D6499-12 n=1.9.8.8.7.6.5.4.3.2.1 ND Bardex ND = Not detectable.5 Covidien Latex Medline Latex Protein Concentration (µg/g) 9 8 7 6 5 4 3 2 1 Evaluation of Allergen Content in Latex Products per ASTM D6499-12 n=1 ND Bardex ND = Not detectable.4 Gloves 8 Condoms Data is based on bench study.
BARD LATEX FOLEY CATHETERS Foley catheters are intended for use in the drainage and/or collection and/or measurement of urine. Cautions: Latex Foley catheters contain natural rubber latex which may cause allergic reactions. Federal (U.S.A.) law restricts these devices to sale by or on the order of a physician. Warnings: On catheter, do not use ointments or lubricants having a petrolatum base. They will damage the catheter and may cause balloon to burst. C. R. Bard, Inc. Covington, GA 314 8.526.4455 bardmedical.com After use, this product may be a potential biohazard. Handle and dispose of in accordance with accepted medical practices and applicable local, state and federal laws and regulations. Please consult product label and insert for any indications, contraindications, hazards, warnings, cautions and directions for use.. Data on file. Based on a study conducted in 212. *. Data is supported by a bench study conducted in 212 using Bardex I.C Foley catheters. Results may not correlate with clinical outcomes. 1. CDC. Gateway to Health Communication and Social Marketing Practice. Latex Allergy. 211. http://www.cdc.gov/healthcommunication/toolstemplates/entertainmented/tips/latexallergy. html 2. Kumar, R Pradeep. Latex Allergy in Clinical Practice. Indian Journal of Dermatology 57.1 (212): 66 7. PMC. 3. FY 216, Global Healthcare Exchange (GHX) Market Intelligence Data. 4. October, 217 Bard Medical Sales Data. 5. 23, Minnesota Rubber and QMR Plastics. 6. 215, 3M, Innovations in Bonding to low surface energy surfaces. 7. Adapted from Roberts, JA, Kaack, MB, Fussell. Adherence to Urethral s by Bacteria Causing Nosocomial Infections. Urology. 1993; 41(4): 338-342. 8. Sales and complaint data from Jan 21 to Dec 217. 9. Kostyal, D. A. & Shay, T. Removal of Natural Rubber Latex Proteins from Foley s. Tech. Sayre, PA: Guthrie Foundation Medical Research, 25. Bard and Bardex are registered trademarks of C.R. Bard, Inc. Bactiguard * is a registered trademark of BactiGuard AB. Al other trademarks are property of their respective owners. *The Foley catheters included in the Bardex I.C. System contain Bactiguard * silver alloy coating which is licensed from BactiGuard AB. 217 C. R. Bard, Inc. All Rights Reserved. 1711-8 BMD/FOCA/1217/71