PI-424803-AA Eluvia In-Service (FINAL).pptx

In-Service
Presentation

3 PI-424803-AA SEP2016 © 2016 Boston Scientific Corporation or its affiliates. All rights reserved.
Product Overview
• Introduction
• Drug-delivery Technology
• MAJESTIC Clinical Trial Results
• Delivery System Design
• Product Specifications & Size Matrix
• Deployment Technique

Introduction

Product Overview
1. Müller-Hulsbeck S. Presented at CIRSE 2016. Represents actual freedom from TLR rate. Kaplan-Meier estimated freedom from TLR is 91.3%. Data on file at Boston Scientific.
2. Data on file at Boston Scientific. Represents total global sales of the PROMUS (Boston Scientific) and XIENCE (Abbott) series of stents since 2007.
Unprecedented
Results
SUSTEND™
Polymer-Based
Drug Delivery
Optimized Stent
Platform
• 92.5% Freedom from TLR at 2 years in the MAJESTIC Trial1
• 91% of patients with no or minimal claudication
• No stent fractures
• The only SFA treatment option that sustains drug release for 12
months, when restenosis is most likely to occur
• Proven polymer implanted in 10 million lesions2 since 2007
• Optimized for flexibility, strength and
fracture resistance
• Triaxial delivery system for
precise deployment
The ELUVIA™ Stent System delivers unprecedented results in
the SFA through its unique SUSTEND™ drug-delivery technology

Drug-delivery
Technology

Stent Design
The ELUVIA™ Drug-Eluting Stent is built
on the INNOVA™ Stent Platform
Designed to optimize:
• Flexibility
• Radial strength
• Fracture resistance
While providing uniform
scaffolding for drug delivery
1. Data on file at Boston Scientific. Represents total global sales of the PROMUS (Boston Scientific) and XIENCE (Abbott) stents since 2007.
2. Data on file at Boston Scientific. Represents total population of patients studied in the PROMUS and XIENCE series of clinical trials.
Close cells
Open cells
Close cells

SUSTEND™ Polymer-Based Drug Delivery
1. Data on file at Boston Scientific. Represents total global sales of the PROMUS (Boston Scientific) and XIENCE (Abbott) stents since 2007.
2. Data on file at Boston Scientific. Represents total population of patients studied in the PROMUS and XIENCE series of clinical trials.
Proven biocompatibility and safety
• Implanted in more than
10 million vessels1 since 2007
• More than 20,000 patients2 studied
in clinical trials
PBMA Primer Layer
Paclitaxel/PVDF-HFP
Active Layer
Stent

Coating Design
1. Data on file at Boston Scientific.
2. Scanning electron microscopy x 100 magnification.
Zilver™ PTX™ ELUVIA™
Medicinal
Substance
Paclitaxel Paclitaxel
Coating Design No carrier
Proven PROMUS
Polymer
Drug/Total Dose1 3µg/mm2
8 x 120mm = 1112 µg
0.167µg/mm2
7 x 150mm = 517 µg
Size Matrix
6-8mm
40-120mm
6 and 7mm
40-150 mm
SEM Image2 100x

Biology of the Restenotic Cascade in the SFA
Forrester et al. JACC 1991; 758-769.
The harsh SFA environment continues to elicit a
response to injury long after an interventional treatment
• Smooth muscle cell proliferation can continue for up to 100 days or longer after stent implantation
• Extracellular matrix formation can continue well beyond 300 days
BIOLOGY OF RESTENOSIS

Clinical Probability of Restenosis
Following SFA Stenting
Iida, O. et al. Catheterization and Cardiovascular Interventions. 2011; 78:611–617.
Kimura T, et al. N Engl J Med 1996;334:561–567.
Restenosis following nitinol stenting in the
SFA peaks at around 12 months
• Timing of SFA restenosis is longer compared to coronary stenting,
which predominantly occurs within 6 months after stenting
CLINICAL HISTORY OF RESTENOSIS

Sustained Drug Release to
Reduce Restenosis
Based on pre-clinical PK analysis. Data on file at Boston Scientific.
Dake MD, et al. J Vasc Interv Radiol. 2011;22(5):603-610.
The ELUVIA™ stent system was designed to sustain
drug release when restenosis is most likely to occur
DRUG TISSUE CONCENTRATIONS OVER TIME

MAJESTIC Clinical
Trial Results

MAJESTIC Clinical Trial
Study Design
• Prospective, single-arm core lab adjudicated clinical study to evaluate the safety and efficacy of
the Eluvia™ Drug-Eluting Vascular Stent System
• 57 subjects across 14 centers in Europe, Australia and New Zealand
• Symptomatic de novo or restenosed lesions in the superficial femoral (SFA) and/or proximal
popliteal arteries (PPA)
Lesion Characteristics (Core Lab Adjudicated)
• 77% of lesions extended into the distal SFA;
9% extended into the PPA
• 65% of lesions severely calcified
• 46% of lesions total occlusions
• 71 mm average lesion length

2-Year Results
*91.3% Kaplan-Meier estimated Freedom from TLR rate
TLR = target lesion revascularization
Efficacy
• 92.5% Freedom from TLR rate at 2 years
• Only two new TLRs between 1 and 2 years
Safety
• 7.5% major adverse event rate (driven
by 4 TLRs with no deaths or amputations)
• No stent fractures upon angiographic
core lab analysis

2-Year Results
Ankle Brachial Index (ABI) is the ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm
Patient Outcomes
• 91% of patients classified as Rutherford Category 0-1 at 2 years
• ABI improvement sustained through 2 years
0%
20%
40%
60%
80%
100%
Baseline (n=57) 1 Month (n=56) 12 Months (n=53) 24 Months (n=53)
RUTHERFORD CATEGORY
5
4
3
2
1
0

The ELUVIA™ Stent Clinical Program
The ELUVIA™ clinical trials are expected to study nearly
1,800 patients across more than 100 centers worldwide.
From PROMISE to PROVEN
n= 299 n= 57 n= 485 n= 750 n= 500
SUPERNOVA
(Innova™ Stent)
MAJESTIC IMPERIAL
RCT
EMINENT
RCT
REGAL
Registry
Prospective,
multicenter single-
arm, open label
Prospective,
multicenter,
single-arm, open
label
Prospective,
multicenter, 2:1
randomization vs.
ZILVER PTX
Prospective,
multicenter,
superitority 2:1
randomization vs.
BMS
All-comers,
multicenter registry
FDA Approval for
Innova Stent
CE Mark for
ELUVIA Stent
FDA Approval
for ELUVIA Stent
Efficacy and
economic data
Efficacy and new
label indications
1-year data
available
2-year data
available
Currently
enrolling
2016 first-patient-
in
2016 first-patient-
in

Delivery System
Design
Prior to use, please review ELUVIA
Directions for Use for full operating
instructions.

Blue outer stabilizing shaft
• Stationary shaft: designed to provide controlled, accurate placement
• Can be pinned in place to maintain position of the stent during deployment
• Braided (stainless steel) for strength and kink resistance
Delivery System Design
Triaxial delivery system for precise stent delivery
Middle shaft
• Mobile shaft: retracts to deploy stent
• Middle shaft radiopaque marker band provides visual
feedback during deployment
• Braided (stainless steel) for strength and kink resistance
Inner shaft
• Stationary shaft: Provides framework
to support stent before deployment
• Distal tip is radiopaque

Designed for intuitive handling and deployment
Thumbwheel
• Provides one-handed deployment
of up to 120 mm of stent length
Pull-grip
• Must be used to
complete deployment of
150 mm stents
Ergonomic handle
For intuitive handling
and stent delivery

Excellent visibility under fluoroscopy
Inner Shaft
Radiopaque Tip
• Marks distal end of
stent delivery system
Middle Shaft Radiopaque Marker Band
• Moves during deployment as middle
shaft retracts and stent deploys
Proximal and Distal Stent Markers
• Four tantalum markers at each
end of the stent

Product Specifications
& Size Matrix

Diameter
(mm)
Length
(mm)
6 40 60 80 100 120 150
7 40 60 80 100 120 150
Working
lengths
75 and
130 cm
Sheath compatibility 6F (2 mm) (across all sizes)
0.035” (0.89 mm) guidewire compatible

Total system length (tip to hub)
75 cm system 130 cm system
All stent lengths 105 cm 160 cm
System Components

Deployment
Technique

Deployment Technique
Prior to use, please refer to the DFU for full operating instructions.
Reference Vessel
Diameter (mm)
Stent Nominal
Diameter (mm)
Stent Lengths
(mm)
Delivery System
Lengths (mm)
4.0 – 5.0 6
40, 60, 80, 100,
120, 150
75, 150
5.0 – 6.0 7
Recommendations
• Upsize by 1 – 2 mm
• Minimum 5 mm coverage of healthy vessel on either end of stent
• Minimum 5 mm of overlap when placing two stents
Stent Sizing

Device Preparation
• Remove slack from the system by advancing the system just beyond the target
lesion then pulling back the system until the radiopaque markers are centered
over the target lesion.
• Check that the Blue Outer Shaft is engaged in the hemostatic valve of the
introducer or guide sheath. Engaging the outer shaft stabilizes the system for
accurate placement.
Proximal and distal
stent markers
Middle shaft
marker band

In some circumstances the blue outer shaft might not be engaged with the valve.
In these cases, it is important to minimize slack using one of these methods:
1
Pin handle
Straighten entire system and hold handle against fixed object (patient’s leg or table).
Pin end of outer blue shaft against fixed object and remove slack between that point and
the hemostatic valve.
Pin outer
blue shaft
Straighten catheter
2

Stent Deployment
• Slowly rotate the thumbwheel until the middle shaft radiopaque marker passes the proximal
stent markers resulting in full deployment, or until arrow is visible on pull grip.
Anchor the handle and gently pull the manual pull grip until the middle shaft radiopaque marker band
passes the proximal radiopaque markers of the stent resulting in full deployment.
Long stents (150mm) require pull-grip activation to complete deployment
When activating the pull-grip, use slow, controlled motion
Middle shaft radiopaque
marker band

Stent Deployment
• View the delivery system under fluoroscopy,
ensuring that the stent is fully deployed.
Use a monorail withdrawal technique for removing device
over guidewire with short strokes to prevent kinking of guidewire.
Middle shaft radiopaque
marker band

Practical Considerations
Accessory devices
• Stiff 0.035in (0.89 mm) guidewires are strongly recommended.
Undersized diameter guidewires provide insufficient support of the stent
system (especially long stent models), which can compromise stent delivery.
• A 260 cm length guidewire is sufficient for most cases. 300 cm wires are
recommended for 130 cm delivery systems.
System prep
• ELUVIA is designed with a single flushing luer.
After flushing the system, simply remove the syringe
and flushing luer as one unit.
• Do not remove the thumbwheel lock prior to deployment.
Premature removal of the thumbwheel lock may result in
an unintended deployment of the stent.

Deployment Technique –
Four Checkpoints
2
Stabilized?
Is the blue outer shaft engaged
in the sheath valve?
2
3 Slow?
Is the operator turning
the thumbwheel slowly?
3
1 Slack?
Is there excess slack in the system?
Straighten.
1
4
Signal?
Is the stent fully deployed when the
thumbwheel tension runs out?
4
150mm stents

Disclaimer
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 labeling supplied with each device. Information for the use only in countries with applicable health authority product
registrations. This material is not for use or distribution in France. Eluvia is a registered or unregistered trademark of Boston Scientific Corporation or
its affiliates. All other trademarks are property of their respective owners.

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