Truly Reliable

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Balloon Valvuloplasty Catheter

R U P T U R E R E S I S TA N T

Fiber Based Technology

Engineered to avoid catastrophic failures

Highly resistant to ruptures, punctures, and tears*

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FasT iNFlaTioN & DeFlaTioN trulyDesigned to minimize rapid pacing times, the True Dilatation™ Balloon Catheter inflates and deflates up to 2 times faster than competitors’ balloons during aortic valvuloplasty.

Company Product Balloon Size Inflation*(Average seconds)

Deflation*(Average seconds)

Bard True DilaTaTion™ 22 mm x 4.5 cm 1.9 3.7

B. Braun Z-Med™ II 22 mm x 4 cm 3.8 6.0

*N=10. Bench data on file. Results may not necessarily be indicative of clinical performance. Different tests may yield different results.

*Bench data on file. Results may not necessarily be indicative of clinical performance. Different tests may yield different results.

Limits the maximum balloon diameter within the labeled size

Offers diameter control with an average balloon growth of 0.6%*

preCisetrulyP R E D I C TA B L E S I Z I N G

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Balloon Valvuloplasty Catheter

Designed to deliver precision and speed, the True Dilatation™ Balloon Catheter enables accurate, controlled, and reliable aortic valve dilatations.

*22 mm x 4.5 cm True Dilatation™ Catheter - N=10; 22 mm x 4 cm Z-Med™ II Catheter - N=10. Bench data on file. Results may not necessarily be indicative of clinical performance. Different tests may yield different results.

More Predictable Sizing vs. Competition*

Size

in M

illim

eter

s (m

m)

Z-Med™ II Catheter22 mm x 4 cm Balloon

21.60 mmRBP

19.90 mmNominal

Balloon Growth from Nominal to RBP1.70 mm

T��� D���������™ Catheter22 mm x 4.5 cm Balloon

22.30 mmRBP

22.10 mmNominal

Balloon Growth from Nominal to RBP0.20 mm

17.00

18.00

19.00

20.00

21.00

22.00

23.00

Labeled Balloon Diameter

*Bench data on file. Results may not necessarily be indicative of clinical performance. Different tests may yield different results.

Bard Peripheral Vascular, Inc.1625 W. 3rd Street Tempe, AZ 85281 USA

Tel: 1 480 894 9515 / 1 800 321 4254Fax: 1 480 966 7062 / 1 800 440 5376

www.bardpv.com

Ordering Information

INSTRUCTIONS FOR USE

Description The True Dilatation™ Balloon Valvuloplasty Catheter is an over-the-wire co-axial catheter with a balloon fixed at the tip. The catheter is 110 cm long and has two lumens: one lumen is used to inflate and deflate the balloon and the other permits the use of a guidewire to position the catheter. The balloon inflation luer-lock hub (angled) connects to a syringe inflation device to deliver radiopaque contrast media for inflation. The guidewire luer-lock hub (straight) connects to the guidewire lumen. The balloon is non-compliant and is designed to reach a known diameter and length when inflated within the specified pressure range. Two radiopaque marker bands are provided for fluoroscopic positioning of the device across the aortic valve. These bands are positioned at the proximal and distal balloon shoulders. Balloon catheter dimensions, balloon nominal pressure, maximum inflation pressure, recommended introducer size, and recommended guidewire size are indicated on the package label.

Packaging Sterile: Sterilized with ethylene oxide gas. Do not use if package is open or damaged.

Storage Store in a cool, dry place.

This device is available by prescription use only.

Indications The True Dilatation™ Balloon Valvuloplasty Catheter is indicated for balloon aortic valvuloplasty.

Contraindications The True Dilatation™ Balloon Valvuloplasty Catheter is contraindicated for use in patients with annular dimensions < 18 mm.

Potential Complications / Adverse Events In the very unlikely event of balloon burst or rupture, balloon could be more difficult to remove through the sheath and could require introducer sheath removal. Potential complications include, but are not limited to: tissue perforation, conduction system injury, thrombo-embolic events, hematoma, cardiovascular injury, arrhythmia development, annular or valvular tearing or trauma, restenosis development, inflammation, infection.

Warnings & Precautions• DO NOT RESTERILIZE AND/OR REUSE, as it may result in compromised

device performance and risk of improper sterilization and cross contamination.

• Balloon valvuloplasty catheters should be used by or under supervision of physicians thoroughly trained in balloon valvuloplasty. A thorough understanding of the technical principles, clinical application, and risk associated with balloon valvuloplasty is necessary before using this device.

• Do not use on or beyond expiration date as per package label.

• Inspect device prior to use. Do not use if there is any indication of damage. Use of damaged devices may result in complications.

• Use device in conjunction with fluoroscopic visualization and proper anti-coagulation as recommended clinically.

• Balloon diameter must be carefully considered in selecting a particular size for a patient. It is critical to perform a clinical diagnostic determination of valve anatomical dimensions prior to use; imaging modalities such as transthoracic echocardiogram (TTE), computerized tomography (CT), angiography, and/or transesophageal echocardiogram (TEE) should be considered. Balloon diameter should not be significantly greater than valvular diameter.

• If using device to support Transcatheter Aortic Valve Implantation (TAVI), consult TAVI system’s Instructions for Use for any additional procedural instructions related to selection and use of valvuloplasty balloon.

• Never use force when advancing or retracting intravascular device without first angiographically determining cause for any resistance. Using force may damage catheter or cause injury to the patient (such as vessel perforation)..

• Do not torque or excessively bend catheter. It can become kinked, adversely affecting performance.

• If flow through catheter becomes restricted, do not attempt to clear catheter lumen by infusion. Doing so many cause catheter to rupture, resulting in vessel trauma. Remove and replace catheter.

• Do not exceed maximum inflation pressure indicated on label. Excess inflation pressure can cause balloon rupture and the inability to withdraw catheter through introducer sheath.

• Withdrawing balloon through introducer sheath may damage balloon.

• Do not remove guidewire from catheter during procedure.

• Use sterile radiopaque solutions (liquid only) to inflate balloon. Fully de-air fluids before use. Do not use air or gas to inflate balloon.

• Do not advance or retract device with balloon inflated. Always confirm that balloon has been completely deflated and is under syringe vacuum force prior to removing.

• If inflating balloon in patient to improve re-folding, ensure balloon is positioned so that it can be inflated safely.

Please consult package insert for more detailed safety information and instructions for use.

Bard and True Dilatation are trademarks and/or registered trademarks of C. R. Bard, Inc., or an affiliate. All other trademarks are the property of their respective owners. Copyright © 2013, C. R. Bard, Inc. All Rights Reserved.

S120388 Rev. 0

Recommended Guidewire .035"

Diameter (mm)

Length (cm)

Nominal (ATM)

RBP (ATM)

Sheath Size (F)

Shaft Length

Order Codes

20 4.5 3 6 11 110 0204511

22 4.5 3 6 12 110 0224512

24 4.5 3 6 12 110 0244512

26 4.5 3 6 13 110 0264513

_____________________________________________________REPRESENTATIVE NAME

_____________________________________________________CONTACT PHONE NO.

_____________________________________________________PHYSICIAN’S SIGNATURE

TighT re-wrap trulyConsistent, tight re-wrap

Low withdrawal profile after dilatation

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Balloon Valvuloplasty Catheter