The document describes the True DilatationTM Balloon Valvuloplasty Catheter. It summarizes that the catheter is designed to: 1) Inflate and deflate up to 2 times faster than competitors' balloons during aortic valvuloplasty. 2) Provide precise and predictable sizing with an average balloon growth of just 0.6% from its nominal diameter. 3) Achieve a tight re-wrap and low withdrawal profile after dilatation for consistent performance.

1. Truly Reliable
T D
™
Balloon Valvuloplasty Catheter

2. 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*
rupture resistANTtruly
FAST inflation & Deflationtruly
Designed 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.

3. Limits the maximum balloon diameter within the labeled size
Offers diameter control with an average balloon growth of 0.6%*
PRECISEtruly
P R E D I C TA B L E S I Z I N G
T D
™
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*
SizeinMillimeters(mm)
Z-Med™
II Catheter
22 mmx4 cm Balloon
21.60 mm
RBP
19.90 mm
Nominal
Balloon Growth from Nominal to RBP
1.70 mm
T D ™
Catheter
22 mmx4.5 cm Balloon
22.30 mm
RBP
22.10 mm
Nominal
Balloon Growth from Nominal to RBP
0.20 mm
17.00
18.00
19.00
20.00
21.00
22.00
23.00
Labeled Balloon Diameter

4. Bard Peripheral Vascular, Inc.
1625 W. 3rd Street Tempe, AZ 85281 USA
Tel: 1 480 894 9515 / 1 800 321 4254
Fax: 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-wraptruly
Consistent, tight re-wrap
Low withdrawal profile after dilatation
T D
™
Balloon Valvuloplasty Catheter