New 3cm Balloon

A shorter length balloon option, in addition to 5.5cm balloon

RX Shortwire CompatibleHelps enable physicians to maintain

control of guidewire and lock the device, no preloaded guidewire to remove

“The 5.5cm balloon works well now, but the 3cm length is optimal to more precisely dilate the bile duct sphincter while maintaining a stable view of the papilla.”

-Dr. Rajesh Keswani, Northwestern University

Contrast Injection Port For convenience and

fluoroscopic visualization

CRE™ RX Biliary Balloon Dilatation Catheter

CRE™

R

X Biliary Balloon

Dilatation Cath

eter

INDICATED

FOR USE IN THE

PROCEDURE

Dilatation Assisted Stone Extraction (DASE) for removal of difficult biliary stones

5.5cm Length

3cm Length

CRE™ Fixed, CRE Wireguided, CRE PRO Wireguided, and CRE RX Biliary Balloon Dilatation Catheters provide

consistent performance for balloon endoscopy to help enable optimal control, efficiency and performance.

The CRE™ RX Biliary Balloon Dilatation Catheters are indicated for use in adults for endoscopic dilatation

of the Sphincter of Oddi with or without prior sphincterotomy. The CRE RX Biliary Balloon Dilatation

Catheters may be used for injection of contrast medium for fluoroscopic visualization of the bile ducts.

www.bostonscientific.com/gastro www.EndoSuite.com

Built on the Foundation of CRE Legacy DesignPlatinum Iridium Radiopague Markers Facilitates positioning and enhances visualization under fluoroscopy.

Pebax™ Balloon Material Designed to produce three distinct diameters at three separate pressures during in vivo dilation.

Rounded Balloon Shoulders Designed to facilitate visualization of dilation through balloon

Order Number

Inflated Balloon OD

Balloon Dilation Length

Inflation Pressures

Catheter Size

Minimum Working Channel

Working Length Pricing

(mm) (Fr) (cm) (ATM) (kPA) (Fr) (mm) (cm)

M00558920 8-9-10 24-27-30 3.0 3-5.5-9 304-608-1013 7.5 3.7 180

M00558930 10-11-12 30-33-36 3.0 3-5-8 304-557-912 7.5 3.7 180

M00558940 12-13.5-15 36-40.5-45 3.0 3-4.5-8 304-507-811 7.5 3.7 180

M00558860 6-7-8 18-21-24 5.5 3-6-10 304-608-1013 7.5 3.7 180

M00558870 8-9-10 24-27-30 5.5 3-5.5-9 304-557-912 7.5 3.7 180

M00558880 10-11-12 30-33-36 5.5 3-5-8 304-507-811 7.5 3.7 180

M00558890 12-13.5-15 36-40.5-45 5.5 3-4.5-8 304-456-811 7.5 3.7 180

M00558900 15-16.5-18 45-49.5-54 5.5 3-4.5-7 304-456-709 7.5 3.7 180

M00558910 18-19-20 54-57-60 5.5 3-4.5-6 304-456-608 7.5 3.7 180

Ordering Information

Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.

CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. Information for use only in countries with applicable health authority registrations. Material not intended for use in France.

CRE™ RX Biliary Balloon Dilatation Catheter

Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.

CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. Information for use only in countries with applicable health authority registrations. Material not intended for use in France.

CPT Copyright 2016 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Restrictions Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

Health economic and reimbursement information provided by Boston Scientific Corporation is gathered from third-party sources and is subject to change without notice as a result of complex and frequently changing laws, regulations, rules and policies. This information is presented for illustrative purposes only and does not constitute reimbursement or legal advice. Boston Scientific encourages providers to submit accurate and appropriate claims for services. It is always the provider’s responsibility to determine medical necessity, the proper site for delivery of any services and to submit appropriate codes, charges, and modifiers for services that are rendered. Boston Scientific recommends that you consult with your payers, reimbursement specialists and/or legal counsel regarding coding, coverage and reimbursement matters. Boston Scientific does not promote the use of its products outside their FDA-approved label.

Boston Scientific Corporation 300 Boston Scientific Way Marlborough, MA 01752 www.bostonscientific.com/gastro

©2017 Boston Scientific Corporation or its affiliates. All rights reserved.

ENDO-499901-AA October 2017

Boston Scientific Contact Information

Name Title

Phone Number Email Address Pricing Expiration Date

Comments

Procedure CPT® Code Description

Dilation Assisted Stone Extraction (DASE)

43264

43277

Endoscopic retrograde cholangiopancreatography (ERCP), with removal of caculi/debris from biliary/pancreatic duct(s) Include modifier 59 with CPT Code 43277 when it is billed with 43264 as “incidental dilation” is considered part of stone removal. Only when the stricture is dilated prior to the removal of the stone can the dilation be separately billed.

Device CPT® Code Description

All CRE Balloon Dilatation Catheters

C1726 18-21-24

Reimbursement Codes

CRE™ RX Biliary Balloon Dilatation Catheter