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In-Service Presentation

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PI-408007-AA JUL2016

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OptiCross™18 IVUS Catheter

Presentation Content:

• iLab POLARIS Multi-Modality System

• BSC IVUS Catheter Offerings

• OptiCross18 IVUS

• OptiCross18 IVUS Catheter Prep

• Capital Placement Programs

• POLARIS Service Options

• IVUS Coding & Medicare Reimbursement

The OptiCross18 IVUS catheter is designed for

exceptional deliverability and improved image

penetration and resolution. Small crossing profile

and shaft stiffness for lesion crossing and 30 MHz

transducer frequency allows for deeper ultrasound

penetration than Atlantis018 with 40 MHz

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iLab POLARIS Multi-Modality System

POLARIS Multi-Modality System

FFR Wires*

Software designed for simplified guidance

Design Goals

» Better wire handling with Asahi tip

» Improved accuracy

» Wireless from bed side

OptiCross™ Catheter IVUS Family

Hardware development designed to improve ease-of-use

Design Goals

» Focus on differentiated catheter offerings

» Improved peripheral and ICE

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iLab POLARIS Multi-Modality System

Installed and Cart configurations

Cart configuration for OPCs

Capital placement programs available

Installed

Cart

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OptiCross18 IVUS: Now Available!

OptiCross IVUS System has excellent deliverability with improved image quality.*

6 F Guide Compatible

Improved

Image Quality

Superior

Deliverability*

Shorter

Tip-to-Transducer

Improved Acoustic

Capabilities

Better MDU

Connection

* OptiCross bench testing versus Atlantis18. Data on file at Boston Scientific

Bench Testing results not necessary indicative of clinical performance

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Product Description

Peripheral Catheters

OptiCross™18 Atlantis018

Transducer Frequency 30 MHz 40 MHz

Order Number H7493932800180 M001FG000240

Typical Use SFA, Popliteal, Tibial,

Renal SFA, Popliteal, Tibial,

Renal

Maximum Diameter Penetration

12 mm 8 mm

Prep Location Proximal Proximal

Catheter Telescoping Length

15 cm 15 cm

Sled Pullback Length 10 cm 10 cm

Distance from Transducer to Tip

2.0 cm 2.6 cm

Guidewire Lumen Length

1.6 cm 1.6 cm

Guidewire Compatibility < 0.018" < 0.018"

Sheath Compatibility (with max wire)

6 F 6 F

Guide Catheter Compatibility

6 F (ID ≥ 0.068”) 6 F (ID ≥ 0.068”)

Imaging Window Profile 2.9 F 3.2 F

Working Length 135 cm 135 cm

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Small Crossing Profile and Smooth Transition for

Better Deliverability

OptiCross18™

* Distal housing is overall length of stiff section including transducer, measured by Boston Scientific

Crossing Profile The biggest profile at distal shaft

3.5F

Min Sheath: 6F

Min guide Catheter:

6F (I.D. ≥ .068")

20 mm

Small crossing profile and shaft stiffness transitions for excellent

deliverability

Lubricious coating promotes deliverability

Rotational transducer is designed to provide smooth pullback and

accurate measurement in Longview

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Imaging Catheter Function

Rotational IVUS Catheter

Using a single transducer

Providing 360o cross-sectional view

One time use for catheterization procedure

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Utilization & Trend

• Endograft placement

• Stent optimization (iliac, SFA)

– Navarro, F., et al. IVUS Assessment of Iliac Stent Procedures

• N = 44 pts, 109 stent placements deemed OK per ateriography

• In 45% of patients, IVUS found 27% of stents under-expanded, dissection, undersized

– Arko, F., et al. Use of IVUS…improves long-term outcome…aortoiliac occlusions

• Retro., N=52 pts with stent placements deemed OK per arteriography, Mean f-up 28 mos

• When used, IVUS found 40% of patients with under-deployed stents

1. Arteriography + IVUS group = no Restenosis/occlusion

2. Arteriography only group = Restenosis/occlusion found in

25% of pts (p<.01)

All found to have under-deployed stents

• Diagnosis

• Improved lesion assessment

Case studies are not necessarily predictive of results in other cases.

Results in other cases may vary.

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OptiCross18 Preparation

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OptiCross18 Preparation (continued)

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Description Product Code

iLab™ System (Cart Version) H749iLab120CART0

OptiCross™18 IVUS Catheter H7493932800180

MDU5+ Motor Drive H749MDU5PLUS0

MDU5+ Sterile Bag H749MDU5PLUSBAG0

Sterile Pullback Sled H749A70200

Sterile Sled Bag H749A70170

UPN / Order Codes

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iLab POLARIS Multi-Modality System

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iLab POLARIS Multi-Modality System

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iLab POLARIS Multi-Modality System

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iLab POLARIS Multi-Modality System

» Software that is intuitive and decreases procedure time

» Hardware that simplifies the procedure

» Family of BSC-IVUS catheters

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OptiCross™18

Imaging Depth = 15 mm

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OptiCross18 0.54 mm 0.88mm 1.17mm 0.97 mm 1.18 mm

Smaller Profile and Smoother Distal Design

Smaller profile for better crossability

Crossing profile (largest profile in distal portion)

Smoother distal design to facilitate better deliverability

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Catheter Tip - Profile

①

Marker Band

Profile

②

GW Exit Port

Profile

③

Transducer Profile

OptiCross18 2.6 F 3.5 F 2.9F

Atlantis018 3.1 F 3.2F 3.2F

OptiCross6 2.2F 3.1F 2.9F

VolcanoPV

.018 3.5F N/A 3.5F

① ②

③

* OptiCross bench testing versus Atlantis18. Data on file at Boston Scientific

VolcanoPV date from Volcano website

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Service – POLARIS ExpertCare

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Service – POLARIS ExpertCare

Standard service contract provisions apply

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Service – POLARIS ExpertCare

Standard service contract provisions apply

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Service – POLARIS ExpertCare

Standard service contract provisions apply

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Service – POLARIS ExpertCare

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Peripheral IVUS Coding & Medicare Reimbursement

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IVUS

New Codes and New Payment Rates

CPT Copyright 2015 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

Note that the example(s) above displays the current CPT code for IVUS, not the 2015 code(s).

Examples shown above are for illustrative purposes only. Medicare and other payers may have specific requirements for documenting and billing related to IVUS. Medicare and other payers may also have policies outlining specific codes that define eligible or ineligible services under which IVUS can be coded. 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.

See important notes on the uses and limitations of this information on next slide

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Important Information

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.

CPT® copyright 2015 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.

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Abbreviated Statement

OptiCross18 IVUS Catheter and MDU5 PLUS Bag

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

INTENDED USE/INDICATIONS FOR USE

OptiCross 18 Catheter: This catheter is intended for intravascular ultrasound examination of peripheral vessels only. Intravascular ultrasound imaging is indicated in patients who are

candidates for transluminal interventional procedures.

MDU5 PLUS Sterile Bag: The MDU5 PLUS Sterile Bag is intended to cover the motordrive during intravascular ultrasound procedures to maintain the sterile field and prevent transfer of

microorganisms, body fluids and particulate material to the patient and healthcare worker.

CONTRAINDICATIONS

Use of this product is contraindicated in the presence of conditions which create unacceptable risk during catheterization.

WARNINGS

• Intravascular ultrasound examination of vascular anatomy should be performed only by physicians fully trained in interventional radiology and in the techniques of intravascular

ultrasound, and in the specific approach to be used, in a fully-equipped cardiac catheterization lab.

• The catheter has no user serviceable parts. Do not attempt to repair or to alter any component of the catheter assembly as provided. Using an altered catheter can result in poor image

quality or patient complications.

• No modification of this equipment is allowed.

• Do not pinch, crush, kink or sharply bend the catheter at any time. An insertion angle greater than 45° is considered excessive.

• Do not manipulate, advance and/or withdraw the coated device through a metal cannula or needle. Manipulation, advancement and/or withdrawal through such a metal device may

result in destruction and/or separation of the outer hydrophilic coating, resulting in coating material remaining in the vasculature, which may cause adverse events and require additional

intervention.

• Do not advance the catheter if resistance is encountered. The catheter should never be forcibly inserted into lumens narrower than the catheter body or forced through a tight stenosis.

• When advancing the catheter through a stented vessel, catheters that do not completely encapsulate the guidewire may engage the stent between the junction of the catheter and

guidewire, resulting in entrapment of catheter/guidewire, catheter tip separation, and/or stent dislocation.

• If resistance is met upon withdrawal of the catheter, verify resistance using fluoroscopy, then remove the entire system simultaneously.

When readvancing a catheter after deployment of stent(s), at no time should a catheter be advanced across a guidewire that may be passing between one or more stent struts. A

guidewire may exit between one or more stent struts when recrossing stent(s). Subsequent advancement of the catheter could cause entanglement between the catheter and the stent(s),

resulting in entrapment of catheter/guidewire, catheter tip separation and/or stent dislocation. Use caution when removing the catheter from a stented vessel.

• Inadequately apposed stents, overlapping stents, and/or small stented vessels with distal angulation may lead to entrapment of the catheter with the stent upon retraction. When

retracting the catheter, separation of a guidewire from an imaging catheter or bending of the guidewire may result in kinking of the guidewire, damage to the catheter distal tip, and/or

vessel injury. The looped guidewire or damaged tip may catch on the stent strut resulting in entrapment.

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Abbreviated Statement

OptiCross18 IVUS Catheter and MDU5 PLUS Bag

PRECAUTIONS

• Do not attempt to connect the catheter to electronic equipment other than the designated Systems.

• Never attempt to attach or detach the catheter while the motor is running.

• If difficulty is encountered when backloading the guidewire into the distal end of the catheter, inspect the guidewire exit port for damage before inserting the catheter into the vasculature.

• Never advance the imaging catheter without guidewire support.

• Never advance the distal tip of the imaging catheter near the very floppy end of the guidewire.

• Never advance or withdraw the imaging catheter without the imaging core assembly being positioned at the most distal portion of the imaging window.

• During and after the procedure, inspect the catheter carefully for any damage which may have occurred during use. Multiple insertions may lead to catheter exit port dimension

change/distortion which could increase the chance of the catheter catching on the stent. Care should be taken when re-inserting and/or retracting catheter to prevent exit port damage.

• Turn the MDU5 PLUS™ “OFF” before withdrawing the imaging catheter.

ADVERSE EVENTS

The risks and discomforts involved in vascular imaging include those associated with all catheterization procedures. These risks or discomforts may occur at any time with varying

frequency or severity. Additionally, these complications may necessitate additional medical treatment including surgical intervention and, in rare instances, result in death.

• Allergic reaction

• Device entrapment requiring surgical intervention

• Embolism (air, foreign body, tissue or thrombus)

• End organ infarction

• Hemorrhage/Hematoma

• Hypotension and/or bradycardia (vasovagal syndrome)

• Infection

• Peripheral ischemia

• Stroke and Transient Ischemic Attack

• Thrombosis

• Vessel occlusion and abrupt closure

• Vessel trauma including, but not limited to dissection and perforation

© 2015 Boston Scientific Corporation or its affiliates. All rights reserved.