INTERVENTIONAL UROLOGY. Unmatched Strength. Exceptional Durability.

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1 Unmatched Strength. Exceptional Durability.

2 One technology...two applications In any stone removal procedure, recurring challenges often include efficient access, smooth navigation through delicate anatomy, and uncompromising dilation of the tract. Bard Endourology seeks constantly to provide newer, more effective surgical tools to meet these challenges. One result is the technology incorporated into our new X-Force balloon dilation catheters, available for two applications: X-Force U30 Ureteroscopic Balloon Dilation Catheter, and X-Force N30 Nephrostomy Balloon Dilation Catheter. Each is designed to meet specific procedural needs based on anatomical approach, and each provides an innovative solution to more effective and efficient stone removal. Radiopaque Tip & Markers Helps guide navigation and assure accurate placement Short, Tapered Tip & Shoulders For smooth, atraumatic insertion, closer proximity to calculi 30 RBP via Patented Multilayer Fiber Technology Delivers up to 50% more dilation force than competitive balloons

3 Labeled Hubs For ease of use, hubs are clearly marked with Rated Burst Pressure and guidewire compatibility Coaxial Shaft Design Results in greater column strength, minimizing kinking and bending during insertion Coatings and Materials Glissando coating on shaft promotes smooth navigation; polyimide inner lumen facilitates movement over guidewire Exclusive Refolding Tool Minimizes profile for atraumatic and efficient reinsertion of balloon

4 An ongoing challenge faced by Urologists in performing stone removal procedures is finding the ideal blend of characteristics in a dilation balloon: efficient access with excellent visibility; exceptional dilation force; and a material durable enough to withstand the pressure and sharp edges of calculi. With the introduction of its new X-Force U30 Ureteroscopic Balloon Dilation Catheter, Bard delivers an innovative solution to this challenge. 1 FINDING A BALLOON DURABLE ENOUGH TO WITHSTAND PRESSURE AND SCRATCHING OF CALCULI THE SOLUTION: A balloon engineered for unmatched durability Patented multilayer technology produces an exceptionally durable balloon that is 2.5X more puncture-resistant than competitive balloons.* Non-compliant balloon maintains diameter and shape even under high pressure. Rated burst pressure of 30 ATM is 50% greater than a leading competitive balloon, effective in resolving both ureteral and urethral strictures. Lbs. of Pressure Puncture-resistance Comparison** X-Force U30 Balloon Leading *Data on file, Bard Medical Division **N = 15

5 2 ACHIEVING PROPER PLACEMENT EASILY AND EFFICIENTLY THE SOLUTION: A design that promotes precise placement and exceptional visibility Low profile eases insertion and helps negotiate tortuous pathways. Coaxial shaft design produces 2X* greater column strength than a leading competitor, minimizing kinking and bending during insertion. Radiopaque tungsten tip and 2 platinum radiopaque markers aid in proper placement. 3 EFFICIENT, ATRAUMATIC REINSERTION OF BALLOON THE SOLUTION: The unique X-Force Refolding Tool Exclusive X-Force Refolding Tool is a patented design and is not available on any other balloon dilation catheter. When the procedure requires it, the Refolding Tool permits effective rewrapping of balloon to a low profile, allowing for atraumatic re-introduction of catheter. *Data on file, Bard Medical Division X-Force U30 Refolding Tool

6 In procedures requiring percutaneous balloon dilation, efficient access can be a challenge. The ideal balloon catheter should offer a combination of superior pressure capacity and a low profile to minimize risk of trauma. With the introduction of its new X-Force N30 Nephrostomy Balloon Dilation Catheter, Bard provides an innovative solution to the challenge. 1 SUFFICIENT DILATION CAPACITY TO EFFECTIVELY OPEN THE TRACT THE SOLUTION: A balloon engineered to deliver 30 ATM Patented multilayer technology produces a balloon with a Rated Burst Pressure of 30 atm, or 50% greater than any competitive balloon, for effective performance in achieving and maintaining even the most challenging nephrostomy access. Non-compliant balloon maintains diameter and shape even under high pressure. Balloon surface Rated Burst Pressure Rated Burst Pressure Comparison 30 ATM 20 ATM ATM 0 X-Force N30 Balloon A B

7 2 ACHIEVING EFFICIENT ACCESS TO THE NEPHROSTOMY TRACT THE SOLUTION: A balloon designed with an ultra-low profile Fr Pre-inflation Balloon Profile Measurements* Fr. 9 Fr. 8 Fr. X-Force N30 Balloon A B Lowest available pre-inflation balloon profile facilitates insertion and minimizes risk of trauma. Coaxial shaft design produces greater column strength than traditional dual-lumen design, minimizing kinking and bending during insertion. Short, tapered tip and balloon shoulders allow placement close to calculi. Inner catheter lumen is polyimide to facilitate movement over guidewire. *N = 3 CREATING AND MAINTAINING AN EFFECTIVE WORKING CHANNEL THE SOLUTION: A sheath specially designed for percutaneous efficiency Straight, symmetrical X-Force balloon eases insertion of sheath for greater procedural efficiency. Beveled end of sheath promotes ease of insertion through muscle, fascia and scar tissue, helping to create a nephrostomy working channel. Sheath features smooth, durable material for minimal resistance to tissue. Available with PTFE and clear material X-Force N30 Balloon A B PTFE PUC

8 Ordering Information Balloon Catheter without Inflation Device Balloon Catheter w/ Eagle Inflation Device* Balloon Size Diameter (mm) Length (cm) RBP (atm) Nominal Pressure** (atm) Shaft Size (F) Ordering Information Balloon Catheter without Inflation Device Balloon Catheter w/ Eagle Inflation Device* Balloon Size Diameter (mm) Length (cm) RBP (atm) Nominal Pressure** (atm) Shaft Size (F) Sheath Material PTFE PTFE Ordering Information Order Number Description Diameter (mm) Sheath Size Length (cm) X-FORCE N30 Balloon Compatibility Units Sheath Material 9911 Long Renal Sheath - Clear , 9961 PVC Standard Renal Sheath - Clear , PVC 9921 Standard Renal Sheath - Clear 9951, 9961 PVC 9931 Long Renal Sheath , 9961 PTFE Standard Renal Sheath , PTFE 9941 Standard Renal Sheath 9951, 9961 PTFE * Eagle Inflation Device (also available separately): 3251 cc/30atm cc/30atm ** Nominal Pressure equals the pressure at which the balloon reaches its labeled diameter. For additional information contact your local Bard representative or call C. R. Bard, Inc. Covington, GA Indications for Use The X-Force Nephrostomy Balloon Dilation Catheter is recommended for use in the dilation of the nephrostomy tract and for placement of the working sheath, and the X-Force Balloon Dilation Catheter is recommended for dilation of the urinary tract. Contraindications Do not use the X-Force Balloon Dilation Catheter in the presence of conditions which create unacceptable risk during the dilation of the nephrostomy tract or urinary tract Warnings: Do not use air or any gaseous substances as a balloon inflation media, always use sterile liquid media. Do not exceed the recommended rated burst pressure (RBP) for this device. Balloon rupture may occur if the RBP rating is exceeded. Please refer to the device label for the recommended maximum rated burst pressure. Extreme caution should be used when considering dilation of irregular, not-compliant tissue or in the presence of certain calculi. Bard, Eagle, Glaissando and X-Force are trademarks and/or registered trademarks of C. R. Bard, Inc C. R. Bard, Inc. All Rights Reserved. Printed in U.S.A R07/06 THP P07/14 2.5M Please consult product labels and inserts for any indications, contraindications, hazards, warnings, cautions and instructions for use.

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