advanced innovation for exceptional...

Advanced Innovation for Exceptional Performance

Long balloons reduce the need for multiple inflations, potentially reducing procedure times

longest BALLOON LENGTHS ON THE MARKET

300 mmBard Peripheral Vascular

U!"#$%&#'&® 014

200 mm

120 mm

40 mm

Armada™ 14

Fox™ sv

RX Viatrac™ 14 Plus

Abbott

220 mm Coyote™

Boston Scientific

200 mmAdvance™ 14 LP

Cook Medical

220 mm

40 mm

SLEEK™ RX

Aviator™ Plus

Cordis

210 mmAmphirion DEEP™

Invatec

210 mmNanoCross™

ev3

* 4x120 mm U!"#$%&#'&® 014 – N=5; 4x120 mm Amphirion DEEP™ N=5; 4x120 mm SLEEK® N=5; 4x120 mm NanoCross™ N=5. p<.05. Data on file. Bench test results may not necessarily be indicative of clinical performance. Di(erent tests may yield di(erent results.

Excellent Trackability U!"#$-C#)''™ Hydrophilic Coating and C*&+,&#™ Flex Points provide excellent trackability when treating long, di(use lesions in challenging anatomies.

Superior Pushability vs. Competitive OTW Balloons

Innovative, reinforced inner lumen promotes improved axial strength for crossing tight lesions.

deliverabilityOPTIMAL

0

100

200

300

4x120 4x120 4x120 4x120

222.79255.73

274.29 281.77

Peak

For

ce (g

F)

NanoCross™

OTW 014AmphirionDEEP™ 014

U!"#$%&#'&®

014SLEEK™

014

Excellent Trackability*

The Trackability Test measures the peak force necessary to track a catheter through an anatomical model.

(Lower is better)

Shaf

t Pus

h E!

cienc

y (%

)

0

5

10

15

20

U!"#$%&#'&®

014NanoCross™

OTW 014AmphirionDEEP™ 014

4x120 4x120 4x120

15.18

12.07 11.31

Superior Pushability*

vs. Competitive OTW Balloons

(Higher is better)

The Pushability Test measures the % of longitudinal force transferred from the hub to the tip of the catheter in an anatomical model.

ULTRA-CROSS™ Dual Layer Hydrophilic Coating - highly lubricious coating that reduces friction imposed on the catheter

CHECKER™ Flex Points - allows the balloon to flex in tortuosity, improving trackability

provides improved axial strength to cross tight lesions

Proprietary ULTRA-CROSS™ Dual Layer Hydrophilic Coating

CHECKER™ Flex Points

Highly Durable Bottom Layer

Highly Lubricious Top Layer

U!"#$%&#'&® 014 PTA Dilatation Catheter Ordering Information

PHYSICIAN’S SIGNATURE

CONTACT PHONE NO.

REPRESENTATIVE NAME

0086

ULTRAVERSE® 014/018 PTA Balloon Dilatation CathetersIndications for Use: U!"#$%&#'&® 014 and U!"#$%&#'&® 018 PTA Dilatation Catheters are recommended for use in percutaneous transluminal angioplasty (PTA) of the renal, popliteal, tibial, femoral and peroneal arteries. These catheters are not for use in coronary arteries.

Contraindications: None known.

Warnings: Contents supplied sterile using ethylene oxide (EO). Non-pyrogenic. Do not use if sterile barrier is opened or damaged. Do not reuse, reprocess or re-sterilize. This device has been designed for single use only. Reusing this medical device bears the risk of cross-patient contamination as medical devices – particularly those with long and small lumina, joints and/or crevices between components – are di(cult or impossible to clean once body fluids or tissues with potential pyrogenic or microbial contamination have had contact with the medical device for an indeterminable period of time. The residue of biological material can promote the contamination of the device with pyrogens or microorganisms which may lead to infectious complications. Do not resterilize. After resterilization, the sterility of the product is not guaranteed because of an indeterminable degree of potential pyrogenic or microbial contamination which may lead to infectious complications. Cleaning, reprocessing and/or resterilization of the present medical device increases the probability that the device will malfunction due to potential adverse e)ects on components that are influenced by thermal and/or mechanical changes. To reduce the potential for vessel damage, the inflated diameter and length of the balloon should approximate the diameter and length 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. If resistance is met during manipulation, determine the cause of the resistance before proceeding. Applying excessive force to the catheter can result in tip breakage or balloon separation. Do not exceed the RBP recommended for this device. Balloon rupture may occur if the RBP rating is exceeded. To prevent over-pressurization, use of a pressure monitoring device is recommended. After use, this product may be a potential biohazard. Handle and dispose of in accordance with acceptable medical practices and applicable local, state and federal laws and regulations.

Precautions: Carefully inspect the catheter prior to use to verify that catheter has not been damaged during shipment and that its size, shape and condition are suitable for the procedure for which it is to be used. Do not use if product damage is evident. The U!"#$%&#'&® 014 and U!"#$%&#'&® 018 PTA Balloon Dilatation Catheters shall only be used by physicians trained in the performance of percutaneous transluminal angioplasty. The minimal acceptable sheath French size is printed on the package label. Do not attempt to pass the PTA catheter through a smaller size introducer sheath than indicated on the label. Do not remove the guidewire in situ to shoot contrast through the wire lumen or perform a wire exchange. If the wire is removed while the balloon catheter is situated in tortuous anatomy, the risk of kinking the catheter is increased. Use the recommended balloon inflation medium (25% contrast medium/75% sterile saline solution). It has been shown that a 25/75% contrast/saline ratio has yielded faster balloon inflation/deflation times. Never use air or other gaseous medium to inflate the balloon. If resistance is felt during post-procedure withdrawal of the catheter through the introducer sheath, determine if contrast is trapped in the balloon with fluoroscopy. If contrast is present, push the balloon out of the sheath and then completely evacuate the contrast before proceeding to withdraw the balloon. If resistance is still felt during post-procedure withdrawal of the catheter, it is recommended to remove the balloon catheter and guidewire/introducer sheath as a single unit. Do not continue to use the balloon catheter if the shaft has been bent or kinked. Prior to re-insertion through the introducer sheath, the balloon should be wiped clean with gauze and rinsed with sterile normal saline. Balloon re-wrapping should only occur while the balloon catheter is supported with a guidewire or stylet. In order to activate the hydrophilic coating, it is recommended to wet the U!"#$%&#'&® Catheter with sterile saline solution immediately prior to its insertion in the body.

Potential Adverse Reactions: The complications that may result from a peripheral balloon dilatation procedure include: y Additional intervention y*Allergic reaction to drugs or contrast medium y Aneurysm or pseudoaneurysm y Arrhythmias y Embolization y Hematoma y Hemorrhage, including bleeding at the puncture site y Hypotension/hypertension y Inflammation y Occlusion y*Pain or tenderness y Pneumothorax or hemothorax y Sepsis/infection y*Shock y Short-term hemodynamic deterioration y*Stroke y Thrombosis y*Vessel dissection, perforation, rupture or spasm.

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

Please consult product labels and package inserts for indications, contraindications, hazards, warnings, cautions and instructions for use.

Bard, Checker, Ultra-Cross, and Ultraverse are trademarks and/or registered trademarks of C. R. Bard, Inc.

Copyright © 2012, C. R. Bard, Inc. All Rights Reserved.

S11744 Rev.1

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

150 cm Catheter Length / .014" Guidewire Compatible

Diameter (mm)

Length (cm)

RBP † (ATM)

Nominal Pressure*

(ATM)

Sheath Size (F) Product Code

1.52 16 6 4 U41501H24 16 6 4 U41501H412 16 6 4 U41501H12

2

2 16 6 4 U4150224 16 6 4 U4150248 15 6 4 U41502810 15 6 4 U415021012 15 6 4 U415021215 15 6 4 U415021522 15 6 4 U415022230 15 6 4 U4150230

2.5

2 16 6 4 U41502H24 16 6 4 U41502H48 15 6 4 U41502H810 15 6 4 U41502H1012 15 6 4 U41502H1215 15 6 4 U41502H1522 15 6 4 U41502H2230 15 6 4 U41502H30

3

2 16 6 4 U4150324 16 6 4 U4150348 15 6 4 U41503810 15 6 4 U415031012 15 6 4 U415031215 15 6 4 U415031522 15 6 4 U415032230 15 6 4 U4150330

† RBP (Rated Burst Pressure): the pressure at which Bard has 95% confidence that 99.9% of the balloons will not burst at or below upon single inflation.

* Nominal pressure: the pressure at which the balloon reaches its labeled diameter.

150 cm Catheter Length / .014" Guidewire Compatible

Diameter (mm)

Length (cm)

RBP † (ATM)

Nominal Pressure*

(ATM)

Sheath Size (F) Product Code

3.5

2 16 6 4 U41503H24 16 6 4 U41503H48 15 6 4 U41503H810 15 6 4 U41503H1012 15 6 4 U41503H1215 15 6 4 U41503H1522 15 6 4 U41503H2230 15 6 4 U41503H30

4

2 16 6 4 U4150424 16 6 4 U4150448 15 6 4 U41504810 15 6 4 U415041012 15 6 4 U415041215 15 6 5 U415041522 15 6 5 U415042230 15 6 5 U4150430

5

2 14 6 5 U4150524 14 6 5 U4150548 13 6 5 U41505810 13 6 5 U415051012 13 6 5 U415051215 13 6 5 U415051522 13 6 5 U415052230 13 6 5 U4150530

Scan with a Smart Phone and your local Bard Rep will contact you.

Advanced Innovation for Exceptional Performance

U!"#$%&#'&® ()*PTA Dilatation Catheter

longest BALLOON LENGTHS ON THE MARKET

300 mmU!"#$%&#'&® 018

Bard Peripheral Vascular

100 mmAdvance™ 18 LP

Cook Medical

220 mmSAVVY™ Long

Cordis

120 mmSubmarine PLUS™

Invatec

200 mmPowerCross™

ev3

Boston Scientific

150 mm Sterling™

Sterling™ ES 40 mm

Long balloons reduce the need for multiple inflations, potentially reducing procedure times

* 6x220 mm U!"#$%&#'&® 018 – N=5; 6x100 mm SAVVY™ – N=5; 6x220 mm SAVVY™ Long – N=5; 6x100 mm Sterling™ – N=5. p<.05. Data on file. Bench test results may not necessarily be indicative of clinical performance. Di(erent tests may yield di(erent results.

Excellent Trackability At least a 20% reduction in tracking force supports outstanding performance in challenging anatomies.

Superior Pushability Innovative, reinforced inner lumen promotes

improved axial strength for crossing tight lesions.

deliverabilityOPTIMAL

ULTRA-CROSS™ Dual Layer Hydrophilic Coating - extremely lubricious coating that reduces friction imposed on the catheter

CHECKER™ Flex Points - allows the balloon to flex in tortuosity, improving trackability

provides improved axial strength to cross tight lesions

Proprietary ULTRA-CROSS™ Dual Layer Hydrophilic Coating

CHECKER™ Flex Points

Highly Durable Bottom Layer

Highly Lubricious Top Layer


Excellent Trackability*

The Trackability Test measures the peak force necessary to track a catheter through a tortuous anatomical model.

(Lower is better)

50

150

250

350

U!"#$%&#'&®

018SAVVY™ Long

OTW 018SAVVY™

OTW 018Sterling™

OTW 018

6x220 6x100 6x220 6x100

Aver

age

Trac

king

Forc

e (g

F)

167.26209.86

309.72 316.39

Superior Pushability*

(Higher is better)

The Pushability Test measures the % of longitudinal force transferred from the hub to the tip of the catheter in an anatomical model.

5

15

25

Push

E!

cienc

y (%

)

U!"#$%&#'&®

018SAVVY™ Long

OTW 018SAVVY™

OTW 018Sterling™

OTW 018

6x220 6x220 6x100 6x100

24.26

13.33 13.11 12.42

U!"#$%&#'&® 018 PTA Dilatation Catheter Ordering Information

0086

ULTRAVERSE® 014/018 PTA Balloon Dilatation CathetersIndications for Use: U!"#$%&#'&® 014 and U!"#$%&#'&® 018 PTA Dilatation Catheters are recommended for use in percutaneous transluminal angioplasty (PTA) of the renal, popliteal, tibial, femoral and peroneal arteries. These catheters are not for use in coronary arteries.Contraindications: None known.Warnings: Contents supplied sterile using ethylene oxide (EO). Non-pyrogenic. Do not use if sterile barrier is opened or damaged. Do not reuse, reprocess or re-sterilize. This device has been designed for single use only. Reusing this medical device bears the risk of cross-patient contamination as medical devices – particularly those with long and small lumina, joints and/or crevices between components – are di(cult or impossible to clean once body fluids or tissues with potential pyrogenic or microbial contamination have had contact with the medical device for an indeterminable period of time. The residue of biological material can promote the contamination of the device with pyrogens or microorganisms which may lead to infectious complications. Do not resterilize. After resterilization, the sterility of the product is not guaranteed because of an indeterminable degree of potential pyrogenic or microbial contamination which may lead to infectious complications. Cleaning, reprocessing and/or resterilization of the present medical device increases the probability that the device will malfunction due to potential adverse e)ects on components that are influenced by thermal and/or mechanical changes. To reduce the potential for vessel damage, the inflated diameter and length of the balloon should approximate the diameter and length 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. If resistance is met during manipulation, determine the cause of the resistance before proceeding. Applying excessive force to the catheter can result in tip breakage or balloon separation. Do not exceed the RBP recommended for this device. Balloon rupture may occur if the RBP rating is exceeded. To prevent over-pressurization, use of a pressure monitoring device is recommended. After use, this product may be a potential biohazard. Handle and dispose of in accordance with acceptable medical practices and applicable local, state and federal laws and regulations.Precautions: Carefully inspect the catheter prior to use to verify that catheter has not been damaged during shipment and that its size, shape and condition are suitable for the procedure for which it is to be used. Do not use if product damage is evident. The U!"#$%&#'&® 014 and U!"#$%&#'&® 018 PTA Balloon Dilatation Catheters shall only be used by physicians trained in the performance of percutaneous transluminal angioplasty. The minimal acceptable sheath French size is printed on the package label. Do not attempt to pass the PTA catheter through a smaller size introducer sheath than indicated on the label. Do not remove the guidewire in situ to shoot contrast through the wire lumen or perform a wire exchange. If the wire is removed while the balloon catheter is situated in tortuous anatomy, the risk of kinking the catheter is increased. Use the recommended balloon inflation medium (25% contrast medium/75% sterile saline solution). It has been shown that a 25/75% contrast/saline ratio has yielded faster balloon inflation/deflation times. Never use air or other gaseous medium to inflate

the balloon. If resistance is felt during post-procedure withdrawal of the catheter through the introducer sheath, determine if contrast is trapped in the balloon with fluoroscopy. If contrast is present, push the balloon out of the sheath and then completely evacuate the contrast before proceeding to withdraw the balloon. If resistance is still felt during post-procedure withdrawal of the catheter, it is recommended to remove the balloon catheter and guidewire/introducer sheath as a single unit. Do not continue to use the balloon catheter if the shaft has been bent or kinked. Prior to re-insertion through the introducer sheath, the balloon should be wiped clean with gauze and rinsed with sterile normal saline. Balloon re-wrapping should only occur while the balloon catheter is supported with a guidewire or stylet. In order to activate the hydrophilic coating, it is recommended to wet the U!"#$%&#'&® Catheter with sterile saline solution immediately prior to its insertion in the body.Potential Adverse Reactions: The complications that may result from a peripheral balloon dilatation procedure include: � Additional intervention �*Allergic reaction to drugs or contrast medium � Aneurysm or pseudoaneurysm � Arrhythmias � Embolization � Hematoma � Hemorrhage, including bleeding at the puncture site � Hypotension/hypertension � Inflammation � Occlusion �*Pain or tenderness � Pneumothorax or hemothorax � Sepsis/infection �*Shock � Short-term hemodynamic deterioration �*Stroke � Thrombosis �*Vessel dissection, perforation, rupture or spasm.Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

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

PHYSICIAN’S SIGNATURE

CONTACT PHONE NO.

REPRESENTATIVE NAME

† RBP (Rated Burst Pressure): the pressure at which Bard has 95% confidence that 99.9% of the balloons will not burst at or below upon single inflation.

* Nominal pressure: the pressure at which the balloon reaches its labeled diameter.

130 cm Catheter Length Dia.

(mm)Length(cm)

RBP†

(ATM) Product Code

2

2 16 U8130224 16 U8130246 16 U8130268 15 U81302810 15 U813021012 15 U813021215 15 U813021522 15 U813022230 15 U8130230

2.5

2 16 U81302H24 16 U81302H46 16 U81302H68 15 U81302H810 15 U81302H1012 15 U81302H1215 15 U81302H1522 15 U81302H2230 15 U81302H30

3

2 16 U8130324 16 U8130346 16 U8130368 15 U81303810 15 U813031012 15 U813031215 15 U813031522 15 U813032230 15 U8130330

3.5


4

2 16 U8130424 16 U8130446 16 U8130468 15 U81304810 15 U813041012 15 U813041215 15 U813041522 15 U813042230 15 U8130430


(mm)Length(cm)

RBP†

(ATM) Product Code

2

2 16 U8150224 16 U8150246 16 U8150268 15 U81502810 15 U815021012 15 U815021215 15 U815021522 15 U815022230 15 U8150230

2.5



(mm)Length(cm)

RBP†

(ATM) Product Code

2

2 16 U875224 16 U8752410 15 U87521012 15 U87521215 15 U87521522 15 U875222

2.5

2 16 U8752H24 16 U8752H410 15 U8752H1015 15 U8752H15

3

2 16 U875324 16 U8753410 15 U87531012 15 U87531215 15 U87531522 15 U875322

3.5

2 16 U8753H24 16 U8753H410 15 U8753H1015 15 U8753H15

4

2 16 U875424 16 U875446 16 U8754610 15 U87541012 15 U87541215 15 U87541522 15 U875422

5

2 14 U875524 14 U875546 14 U8755610 13 U87551012 13 U87551215 13 U87551522 13 U875522

6

2 14 U875624 14 U875646 14 U8756610 12 U87561012 12 U87561215 12 U87561522 12 U875622

7 4 12 U875748 4 12 U875849 4 11 U87594


(mm)Length(cm)

RBP†

(ATM) Product Code

5

2 14 U8130524 14 U8130546 14 U8130568 13 U81305810 13 U813051012 13 U813051215 13 U813051522 13 U813052230 13 U8130530

6

2 14 U8130624 14 U8130646 14 U8130668 12 U81306810 12 U813061012 12 U813061215 12 U813061522 12 U813062230 12 U8130630

7 4 12 U8130748 4 12 U8130849 4 11 U813094


(mm)Length(cm)

RBP†

(ATM) Product Code

3

2 16 U8150324 16 U8150346 16 U8150368 15 U81503810 15 U815031012 15 U815031215 15 U815031522 15 U815032230 15 U8150330

3.5


4

2 16 U8150424 16 U8150446 16 U8150468 15 U81504810 15 U815041012 15 U815041215 15 U815041522 15 U815042230 15 U8150430

5

2 14 U8150524 14 U8150546 14 U8150568 13 U81505810 13 U815051012 13 U815051215 13 U815051522 13 U815052230 13 U8150530

Please consult product labels and package inserts for indications, contraindications, hazards, warnings, cautions and instructions for use.

Bard, Checker, Ultra-Cross, and Ultraverse are trademarks and/or registered trademarks of C. R. Bard, Inc. All other trademarks are the property of their respective owners.

Copyright © 2012, C. R. Bard, Inc. All Rights Reserved.

S11742 Rev. 1

Nominal PressureAll codes 6 ATM

Sheath2 mm x 2 cm - 4 mm x 12 cm 4F4 mm x 15 cm - 7 mm x 4 cm 5F8 mm x 4 cm - 9 mm x 4 cm 6F


Scan with a Smart Phone and your local Bard Rep will contact you.

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