Sapphire and OrbusNeich are registered Trademarks of OrbusNeich Medical, Inc. All data and photos on file. Illustrations are not to be considered as engineering drawings or photos.

For more information please visit our website at www.OrbusNeich.com or contact us:

© 2016 OrbusNeich. All rights reserved. Not available for sale in the USA.

#G-70-0283 Rev03

EMEA HEADQUARTERSDrs. W. van Royenstraat 5 3871 AN HoevelakenThe NetherlandsPhone +31.33.254.1150 Toll Free Phone 00800.0254.1150*Fax +31.33.254.1151 Toll Free Fax 00800.0254.1151*

* Only for Belgium, Denmark, France, Germany, Ireland, Netherlands, Norway, Sweden and UK

Catheter Working Length (140 cm)

Distal Shaft (2.36F – 2.6F) Exit Markers

Proximal Shaft O.D. (2.0F)

Transition ZoneRx Port

Hub

Ordering Information

8

117-1708117-2008117-2208117-2508117-2708117-3008117-3208117-3508117-3708117-4008117-4508117-5008

10

117-1710117-2010117-2210117-2510117-2710117-3010117-3210117-3510117-3710117-4010117-4510117-5010

12

117-1712117-2012117-2212117-2512117-2712117-3012117-3212117-3512117-3712117-4012117-4512117-5012

15

117-1715117-2015117-2215117-2515117-2715117-3015117-3215117-3515117-3715117-4015117-4515117-5015

18

117-1718117-2018117-2218117-2518117-2718117-3018117-3218117-3518117-3718117-4018117-4518117-5018

Balloon Working Length (mm)

1.752.02.252.52.753.03.253.53.754.04.55.0

Balloon Diameter (mm)

Pressure atm (kPa)Balloon Diameter (mm)

Compliance Chart

NOM*

RBP**RBP**

1.75

1.681.701.731.751.771.801.821.841.871.891.92

2.0

1.901.931.972.002.032.072.102.132.162.202.23

2.25 2.5

2.402.442.472.502.532.562.602.632.662.692.72

2.75

2.612.662.702.752.802.842.892.932.983.023.07

3.0

2.862.912.953.003.053.093.143.183.233.273.32

3.25

3.103.153.203.253.303.353.403.453.503.553.59

3.5

3.333.393.443.503.563.613.673.723.783.833.89

3.75

3.543.613.683.753.823.893.964.034.104.174.24

4.0

3.793.863.934.004.074.144.214.274.344.414.48

4.5

4.264.344.424.504.584.664.744.824.904.985.06

5.0

4.704.804.905.005.105.205.305.405.495.595.69

68101214161820222426

(608)(811)(1013)(1216)(1419)(1621)(1824)(2027)(2229)(2432)(2634

* Nominal Pressure. The nominal in vitro device specifications do not take into account any lesion resistance.* * Rated Burst Pressure. Do not exceed RBP

2.142.172.212.252.292.332.362.402.442.482.51

CORONARY BALLOON

True Controlled Compliance and Ultimate Crossability for a

Wide Spectrum of Vessels

Ultimate Crossability and Tip Entry Profile

True Controlled Compliance and Ultimate Crossability for a Wide Spectrum of Vessels

Sapphire II NC Coronary Dilatation Catheter is a well-balanced and truly non-compliant balloon catheter engineered to cross tight and calcified lesions.

True non-compliance and minimal overstretch for reliability and size accuracy. Sapphire NC brings advanced material engineering for optimum reliability and deliverability.

Crossing Profile Comparison

Data on file.

0.040

0.039

0.038

0.037

0.036

0.035

0.034

0.033

0.032

0.031NC Trek

0.0380

Hiryu

0.0373

Lifespear

0.0361

QuantumApex

0.0360

SapphireII NC

0.0336

Enhanced distal Z-Tip with advanced laser welding technology for “ZERO” transition with conventional steerable guidewires

True Controlled Compliance

Compliance Comparison from Nominal Pressure to RBP

10.0

8.0

6.0

4.0

1st 2nd 3rd 4th 5th

Sapphire I I NC (3.0x18 mm)

Gro

wth

Rat

e (%

)

Inflation cycles

Hiryu (3.0x15 mm)

Quantum Apex (3.0x15 mm)

NC Trek (3.0x15 mm)

Data on file.

“ZERO” transition between distal leading tip and conventional 0.014” guidewire

Lowest compliance growth rate at every inflation

Technical Specifications

Proximal Shaft

Distal Shaft

Catheter Working Length

Tip Length

Marker Bands

Coating

Nominal Pressure

Rated Burst Pressure

2.0F

140 cm

2

12 atm

20 atm (1.75 - 4.0 mm); 18 atm (4.5 - 5.0 mm)

1.5 mm tip for Ø 1.75 mm; 2.0 mm tip for Ø 2.0 - 3.0 mm2.5 mm tip for Ø 3.25 - 5.0 mm

Hydro-X (distal tip to guidewire exit port); InvioTM (guidewire lumen)

2.36F (1.75 - 2.0 mm); 2.55F (2.25 - 3.5 mm)2.6F (3.75 - 5.0 mm)

Special proprietary balloon processing resulting in superb crossing profile for primary and repeated lesion entry

(inch

)