IN-SERVICE PRESENTATION - 6-th Coronary...

IN-SERVICE PRESENTATION

IC-215308-AG OCT2015 1 of 84 This material is not for use in the U.S., France or Japan.

What have we achieved together?

E v o l u t i o n o f S t e n t D e s i g n

ADVANCING CARDIOLOGY TOGETHER

SYNERGY™ Stent

System

Promus PREMIER™

Stent System

TAXUS Element™

and PROMUS

Element™ Stent

Systems

TAXUS™ Liberté™

Stent System

TAXUS™ Express2™

Stent System

PROMUS™ Stent

System

2003 2005 2006 2009-2010 2013 2013

IC-215308-AG OCT2015 2 of 84 This material is not for use in the U.S., France or Japan.

Because you never know when life will become complex.

The SYNERGY™ Stent System is uniquely suited

for challenging cases.

DESIGNED TO HEAL UNMATCHED ACUTE PERFORMANCE

This material is not for use in the U.S., France or Japan. IC-215308-AG OCT2015 3 of 84

Vascular Response to Current Permanent Polymers The case for bioabsorbable polymer coatings

CoCr EES

EES implanted

within PES

(6 months

antemortem)

CoCr EES

Foamy macrophage

accumulation

(neoatherosclerosis)

CoNi ZES

Chronic inflammation

with giant cells

secondary to polymer

delamination

(3 months)

CoCr EES

Focal inflammation

with eosinophils

(4 months)

Focal

Inflammation

Chronic

Inflammation

Neo-

Atherosclerosis

Late Stent

Thrombosis

Images Courtesy of Renu Virmani, MD.


No. at risk

Resolute Stent 1140 1110 1035 992 960 920

Xience V Stent 1152 1122 1031 995 959 926

2nd Generation DES Continuous accrual of Events

40

Years

0 1 3 2

TL

F R

ate

(%

)

0

10

30

16.3% 17.1%

Log rank P = 0.65 Resolute™ ZES (N = 1140)

Xience V™ EES (N = 1152)

Primary endpoint

Pnon-inferiority <0.001

8.3% 8.2%

20

5 4

~2% Event Rate/Year after Year 1

RESOLUTE All Comers

TLF = cardiac death, target vessel MI or clinical driven TLR Adapted from a presentation by Stephan Windecker, MD at PCR 2014.


DES Polymer Considerations

• Provide a mechanically stable matrix for the drug

• Modulate drug release into the vessel wall

• Polymer remaining after drug release has no function

• All polymer coatings have the potential to be damaged

• Permanent polymers are permanent

What is the purpose of a DES polymer?

What happens after drug release?

Clinical Implications

• Late / very late events

• Chronic inflammation with neoathersclerosis

• Constant irritant may lead to late restenosis

Boston Scientific data on file.


SYNERGY™ Stent System

HEAL with Confidence

Designed to Heal

Early Healing

Freedom from Long-term Polymer Exposure




Designed to Heal

Early Healing



Impact of Stent Design on Healing

• Strut thickness

• Polymer Location

• Polymer Load and Duration

Design Factors

Impacting Healing

Optimal Healing

• Increased Endothelial Coverage

• Reduced Inflammation

• Reduced Likelihood of Stent Thrombosis


Arterial Wall

PROMUS™ Element Stent Conformal Permanent Polymer

SYNERGY Stent Abluminal PLGA Bioabsorbable Polymer

20% Thinner Struts

78 µm* Strut + Polymer

97 µm Strut + Polymer

SYNERGY™ Everolimus-Eluting Stent Product Summary

• Polymer is gone when no longer needed, shortly after completion of drug elution at 3 months

• Applied to the abluminal side of the stent, designed for optimal healing

• Providing Suppression of neointimal growth at the arterial wall & Promotion of healing inside the lumen

*Strut thickness for small vessel model is 74μm, Workhorse model is 79μm and large vessel is 81μm. Boston Scientific data on file.

Synchrony™ Bioabsorbable Coating

Thin Abluminal

Coating


SYNERGY™ Stent Synchrony™ Bioabsorbable Coating

Wilson, G.J., et al. Catheter Cardiovasc Interv. 2015.

PLGA

Mass Remaining

Everolimus

Mass Remaining

100

80

60

40

20

0

0 3 6 9 12

Time (months)

Ma

ss R

em

ain

ing (

%)

Freedom from long-term polymer exposure

Polymer is completely absorbed when it is no longer needed


Synchrony™ Bioabsorbable Coating Drug Arterial Concentration and Release Kinetics

0

3

6

9

0 30 60 90 120E

vero

lim

us T

issu

e C

on

cen

trati

on

(

ng

/mg

)

Time (days)

SYNERGY

PROMUS Element

0

25

50

75

100

0 30 60 90

% E

vero

lim

us

Rele

ase

Time (days)

SYNERGY

PROMUS Element

Arterial Everolimus Concentration*

Drug Release Profiles*

The SYNERGY™ Stent has similar release kinetics and

arterial drug concentrations as Promus PREMIER™ Stent

Everolimus is still present in the tissue out to 120 days

while polymer completes absorption

SYNERGY Stent

Promus PREMIER Stent

SYNERGY Stent


Wilson, G.J., et al. Cathet. Cardiovasc. Intervent. 2015.le. *Data points determined from an in vivo non-injured swine model.


Bioabsorbable Scaffold

Bioabsorbable Polymer in Perspective Relative Polymer and Drug Absorption Profiles

1 Boston Scientific data on file. 2 World J Cardiol 2011 March 26; 3(3): 84-92. 3Garg, S, J Am Coll Cardiol. 2010;56 (10s1):S43-S78. doi:10.1016. 4 Presented by Stephan Windecker, MD, TCT2012.

Absorb™ BVS3

Polymer Scaffold: PLLA

Polymer Coating: PDLLA

Absorption Time:

>2 yrs

Bioabsorbable Polymer-Coated Stents

SYNERGY™1

Stent

Polymer Coating: PLGA

Absorption Time:

3-4 mo

Polymer Coating: PLA

Absorption Time:

>9 mo

Nobori™2 and BioMatrix Flex™3

Stents

Orsiro™4

Stent

Polymer Coating: PLLA

Absorption Time:

>12 mo

% R

ec

ove

ry

Time (months)

Everolimus

PLGA

% R

ec

ove

ry

Time (months)

BA9

PLA %

Rec

ove

ry

Time (months)

Sirolimus PLLA (molecular weight change)

% R

ec

ove

ry

Time (months)

Everolimus

PLLA

This material is not for use in the U.S., France or Japan.

The SYNERGY Stent‘s polymer is absorbed

shortly after drug elution ends at 3 months

IC-215308-AG OCT2015 13 of 84

Metal Matters PtCr Alloy is the Foundation of Stent Performance

• Enhanced Visibility

• Exceptional Radial Strength

& Conformability

• Minimized Recoil

Key Advantages

37%

3%

9%

18%

33%

Iron

Molybdenum

Nickel

Chromium

Platinum

Trace Manganese

Boston Scientific Corporation data on file.

Platinum Chromium Alloy

Platinum has over 2X the density of Iron or Cobalt

Platinum provides increased strength when alloyed

with stainless steel

Specifically developed for coronary stents


SYNERGY

Stent

Promus PREMIER™

Stent

Resolute Integrity™

Stent

XIENCE Xpedition™ /

Alpine™

Stent

Alloy PtCr PtCr CoNi CoCr

Strut

Thickness 74 µm** 81 µm 91 µm 81 µm

*Testing Completed by Boston Scientific data on file. 2.5 mm stent products tested. Based on 2.5mm stents. Under 6.0mm copper phantom to simulate body mass. Bench test results may not

necessarily be indicative of clinical performance.

**Strut thickness for small vessel model is 74μm, Workhorse model is 79μm and large vessel is 81μm. Boston Scientific data on file.

Even with thin struts the high density of

Platinum Chromium allows for greater visibility*

SYNERGY™ Stent Best-in-Class Visibility


Polymer Coating Type &

Thickness

Strut Thickness

Total Coated

Strut Thickness

Thin Struts and Lower Coating Thickness

SYNERGY™ Stent Product Summary

Xience V™, Xience Prime™1,

Xience Xpedition™1,

Xience Alpine™ Stents

PROMUS Element™1 Stent

Promus PREMIER™ Stent

SYNERGY1 Stent ABSORB™ BVS3

74 µm*

(0.0029”)

150 µm

(0.0059”)

120 µm

(0.0047”)

81 µm

(0.0032”)

BioMatrix Flex™2

Stent

Bioabsorbable

Abluminal

4 µm

Bioabsorbable

Abluminal

10 µm

Conformal

Permanent

8 µm

Bioabsorbable

Conformal

3 µm / side

130 µm 78 µm 156 µm 97 µm

*Strut thickness for small vessel model is 74μm, Workhorse model is 79μm and large vessel is 81μm. Boston Scientific data on file. Representative drawings are to scale.

Representative drawings. 1 Wilson GW, EuroIntervention 2012;8:250-257, and Soucy NV, EuroIntervention 2010;6:630-637. 2 Gutiérrez-Chico JL, American Heart Journal November 2011;

162:922–931. 3 Onuma Y, Circulation 2011, 123:779-797. Bench test results may not necessarily be indicative of clinical performance.


SYNERGY™ Stent 1 month DAPT labelling update now CE marked

Physicians should use the information from the large body of clinical evidence for everolimus drug eluting stents,

coupled with current literature on drug-eluting stents, current European Society of cardiology recommendation or

other applicable country guidelines and the specific needs of the individual patient to determine the specific

antiplatelet / anticoagulation regimen to be used for their patients in general practice.

It is very important that the patient be compliant with post-procedural antiplatelet recommendations given by their

physician. In selected higher risk patients where the physician determines that the risks outweigh the benefits of

continued DAPT, it may be reasonable to interrupt or discontinue therapy after 1 month based on low stent

thrombosis rates and no observed increased risk for stent thrombosis as shown in the current literature. Patients

who require premature discontinuation of antiplatelet therapy should be monitored closely and have their

antiplatelet therapy restarted as soon as possible per the discretion of their treating physician.

Individualisation of Patient Treatment

The device carries an associated risk of acute, sub-acute or late thrombosis, vascular

complications, and/or bleeding events. Therefore, patients should be carefully

selected, and a P2Y12 inhibitor (i.e., clopidogrel, ticlopidine, prasugrel, or ticagrelor)

must be prescribed post procedure to reduce the risk of stent thrombosis. Aspirin

must be administered concomitantly with the P2Y12 inhibitor, and then continued

indefinitely to further reduce the risk of thrombosis.

Antiplatelet drugs should be used in combination with SYNERGY which is designed

with a low initial polymer load, abluminal coating and bioabsorbable polymer which

may reduce the risk of thrombosis and the need for prolonger dual antiplatelet

therapy.

^ The updated Directions for Use will also include an update on the current “Pre-and Post-Procedure Antiplatelet Regimen”:

In selected higher risk patients where the physician determines that the risks outweigh the benefits of continued DAPT, it may be reasonable to interrupt or discontinue therapy after 1

month based on low stent thrombosis rates and no observed increased risk for stent thrombosis as shown in the current literature. Patients who require premature discontinuation of

antiplatelet therapy should be monitored closely and have their antiplatelet therapy restarted as soon as possible per the discretion of their treating physicians


Pre- and Post-procedure DAPT Labeling

*From respective products’ DFUs. Indications, contraindications, warnings, precautions and instructions for use can be found in the product labeling supplied with each device. All trademarks are the property of their respective owners.

Absorb™ BVS

“Antiplatelet drugs should be used in combination with

the Absorb BVS. Physicians should use the information

from the SPIRIT Clinical trials and the ABSORB trials,

coupled with the current literature on drug-eluting stents

/scaffolds and the specific needs of the individual

patients, to determine the specific

antiplatelet/anticoagulation dose and duration to be used

for their patients in general practice. A minimum of 6

months duration is recommended.”

BioMatrix Flex™ Stent

“Clopidogrel is required for a minimum of 6 months and

strongly recommended for 12 months in patients who are

not at high risk of bleeding per the ACC/AHA/SCAI 2005

Guideline Update for Percutaneous Coronary

Intervention. Acetylsalicylic acid is to be administered

indefinitely to reduce the risk of thrombosis.”

Orsiro™ Stent

“It is very important that the patient is compliant with the

post procedure antiplatelet recommendation.

Premature discontinuation of prescribed antiplatelet

medication could result in a higher risk of thrombosis,

myocardial infarction or death.”

Nobori™ Stent

“Judicious selection of patients is necessary since the

use of this device carries the associated risk of sub-

acute thrombosis, vascular complications and/or

bleeding events. Hence patients should be maintained

on clinically adequate post-procedural antiplatelet

therapy (aspirin and thienopyridine, or other

appropriate antiplatelet agents).”

The SYNERGY™ Stent is the only bioabsorbable

polymer coated stent with 1-month DAPT labeling*


SYNERGY™ Coronary Stent System New Indications and Labelling Updates Now CE Marked

CE Mark

Acute Coronary Syndrome (ACS)

Acute Myocardial Infarction (AMI)

Unstable Angina

Renal Failure

Coronary Bifurcation Lesions1

Coronary Multi-vessel Disease

Coronary Saphenous Vein Graft Lesions

Coronary Artery Ostial Lesions

Unprotected Left Main Coronary Artery Lesions

Coronary Artery Total Occlusion Lesions2

In-Stent Restenosis in Coronary Artery Lesions3

1 When treating Bifurcations, care must be exercised to access the secondary vessel via the repeating geometry in the body of the stent within the primary vessel. 2 For treatment of occluded vessels, contrast visualization of the distal vessel to confirm position of guidewire within the lumen is recommended. 3 For in stent restenosis, where details of the original stent are known, the expanded inner diameter of the new stent should not exceed the dilation limits of the original stent. Where details of the

original stent are not known, the expanded inner diameter of the new stent should not exceed the reference vessel diameter.

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.


SYNERGY™ Stenting Left Main

SYNERGY™ Stent is indicated for treatment of patients

presenting with unprotected left main coronary artery lesions:

1. Shand J, et al. Prospective Intravascular Ultrasound Investigation of the Necessity for and Efficacy of Postdilation Beyond Nominal Diameter of 3 Current Generation DES Platforms for the Percutaneous Treatment of the Left Main Coronary Artery. Cathet Cardiovasc Intv; 2014;84:351-358.

2. Labeled Post-Dilatation Limits. SYNERGY Stent, Xience Xpedition Stent , Resolute Integrity Stent and Resolute Onyx DFU 3. Adapted from presentations by Prof. RJ van Geuns, MD, PhD; and Jiang Ming Fam, MD at AsiaPCR 2015 4. Bench testing performed by Boston Scientific Corporation. Data on file at Boston Scientific. All stents 2.5mm. SYNERGY Stent n=5, all other stents are n=3. Bench test results not

necessarily indicative of clinical performance. 5. EVOLVE Clinical trial at 4 year. Presented by Ian T. Meredith AM, MBBS, PhD, PCR 2015. EVOLVE II Clinical Trial. Presented by Dean J. Kereiakes, MD at AHA 2014. EVOLVE II

DM Clinical Trial. Presented by Stephan Windecker, MD at PCR 2015. Adapted from a presentation by J. M. de la Torre, MD at PCR 2015. Wilson G, MD. ACC 2011.

Left Main vessels are Large (>5.5mm on average1)

• SYNERGY™ Stent is indicated for treatment of patients presenting

with unprotected left main coronary artery lesions

• SYNERGY has a labeled overexpansion indication of up to

5.75mm2

Left Main Vessels require stents with significant radial strength3

• SYNERGY offers excellent radial strength4

Left Main PCI needs optimal Vessel Healing3

• The SYNERGY DES shows healing within 3-month and has low

risk of cardiac adverse events in complex patients5

IVUS LM in male patients

Graph Prof. Robert Jan van Geuns. IVUS LM in male

pts (Rotterdam). Asia PCR 2015.

IVUS data on 865 LAD->LM pullbacks, male patients .

Average Vessel Diameter (VD): 5.60 mm , Mean VD:

5.47 mm. Only in 13% <5 mm.


SYNERGY™ Stenting Total Occlusion


presenting with total occlusion coronary artery lesions:

For treatment of occluded vessels with the SYNERGY stent system, contrast visualization of the distal vessel to confirm position of guidewire within the lumen is recommended.

1 Labeled Post-Dilatation Limits. SYNERGY Stent, Xience Xpedition Stent , Resolute Integrity Stent and Resolute Onyx DFU

2 Bench testing performed by Boston Scientific Corporation. Data on file at Boston Scientific. All stents 2.5mm. SYNERGY Stent n=5, all other stents are n=3. Bench test results not

necessarily indicative of clinical performance.

3 EVOLVE Clinical trial at 4 year. Presented by Ian T. Meredith AM, MBBS, PhD, PCR 2015. EVOLVE II Clinical Trial. Presented by Dean J. Kereiakes, MD at AHA 2014. EVOLVE II DM

Clinical Trial. Presented by Stephan Windecker, MD at PCR 2015. Adapted from a presentation by J. M. de la Torre, MD at PCR 2015. Wilson G, MD. ACC 2011.

CTO lesions tend to be long and located in large vessels

• SYNERGY has a labeled overexpansion of up to 5.75mm,

allowing the physician to customize the stent to the

appropriate vessel size1

Stent mechanical properties are important considerations

for CTO stenting

• The SYNERGY Stent’s customized architecture

offers exceptional strength and conformability2

Chronic Total Occlusion PCI needs optimal Vessel Healing

• The SYNERGY DES shows healing within 3-months and

has low risk of cardiac adverse events in complex patients3


SYNERGY™ Stenting Bifurcation


presenting with bifurcation coronary artery disease:

When treating Bifurcations, care must be exercised to access the secondary vessel via the repeating geometry in the body of the stent within the primary vessel.

1 Attributes collected from: Curtiss T. Stinis, M.D., F.A.C.C, F.S.C.A.I. - Scripps CI 2013 and ESC/EACTS GUIDELINES 2014. EHJ doi:10.1093/eurheartj/ehu278. 2 Labeled Post-Dilatation Limits. SYNERGY Stent, Xience Xpedition Stent , Resolute Integrity Stent and Resolute Onyx DFU 3 Bench testing performed by Boston Scientific Corporation. Data on file at Boston Scientific. All stents 2.5mm. SYNERGY Stent n=5, all other stents are n=3. Bench test results not necessarily indicative of clinical performance. 4 Circular Cell Diameter: n = 5. Data on file at Boston Scientific. Size Matrix on the SYNERGY Stent DFUs. 5 EVOLVE Clinical trial at 4 year. Presented by Ian T. Meredith AM, MBBS, PhD, PCR 2015. EVOLVE II Clinical Trial. Presented by Dean J. Kereiakes, MD at AHA 2014. EVOLVE II DM Clinical Trial. Presented by Stephan Windecker, MD at PCR 2015. Adapted from a presentation by J. M. de la Torre, MD at PCR 2015. Wilson G, MD. ACC 2011.

Bifurcation lesions are often tapered1

• SYNERGY has a labeled overexpansion of up to 5.75mm, allowing the

physician to customize the stent to the appropriate vessel size and ensure great

apposition2

With bifurcation we want to maintain the natural vessel shape1

• The SYNERGY Stent’s customized architecture offers exceptional strength and

conformability3

Bifurcation PCI benefits from an appropriate Cell Diameter & Expansion1

• The SYNERGY Stent has large cell diameters in the body of the stent to

accommodate side branch access4

Bifurcation lesions need optimal Vessel Healing to reduce risk of ST1

• The SYNERGY DES shows healing within 3-month and has low risk of cardiac

adverse events in complex patients5


SYNERGY™ Stent Enhanced Platform Strength and Flexibility Where It Matters

1 The Small Vessel and Workhorse sizes have 4 connectors on the two most proximal segments. The Large Vessel sizes have 5 connectors on the two most proximal segments. 2 Bench testing, 3.0 mm stents performed by Boston Scientific Corporation. Bench test results may not necessarily be indicative of clinical performance. Boston Scientific Data on File.

Customized Stent Architecture


Strut thickness, peak radius

and connector angles designed to

improve crimping profile and

deliverability over


Connector Angle Comparison

Additional connectors on

proximal two segments

2 connectors throughout body SYNERGY Stent

Robust proximal end for increased axial

strength1

Overall design maintains

flexibility and conformability2


1. Circular Cell Diameter: n = 5.

2. Data on file at Boston Scientific. Stent to Artery Ratio is a calculated value.

3 Stent Models for more consistent

acute performance across the matrix

Diameter Stent Model Circular Cell Diameter1

inches (mm)

Stent to Artery

Ratio2

Stent Strut Wall

Thickness

2.25 mm SV 0.028”

(0.72 mm) 15.8 % 74 µm

2.50 mm SV 0.031”

(0.78 mm) 14.3 % 74 µm

2.75 mm SV 0.033”

(0.85 mm) 13.1 % 74 µm

3.00 mm WH 0.039”

(0.98 mm) 14.0 % 79 µm

3.50 mm WH 0.046”

(1.16 mm) 12.1 % 79 µm

4.00 mm LV 0.042”

(1.08mm) 13.8 % 81 µm

SYNERGY™ Stent Three unique, customized stent models


Circular Cell Diameter (CCD) is the diameter of the largest circle that can be inscribed within

a stent cell when deployed to nominal size where the circle contacts the enclosing stent struts

at a minimum of three points.

IC-215308-AG OCT2015 24 of 84

SYNERGY™ Stent Maximum Cell Diameter in Millimeters

Model Diameter Size(s) # of Connectors Proximal End

MECD (mm)

Rest of Stent

body MECD (mm)

Small Vessel 2.25mm, 2.50mm

& 2.75mm

4 on proximal end;

2 throughout stent

body

2.3mm 4.5mm

Workhorse 3.00 & 3.50mm 4 on proximal end;

2 throughout stent

body

2.7mm 5.5mm

Large Vessel 4.00mm 5 on proximal end;

2 throughout stent

body

2.9mm 7.1mm

Additional connectors

on proximal two

segments

2 connectors throughout body

Source: Data on File at Boston Scientific – Stent MECD Technical _Report; PDM doc. 91019938


Maximum Expanded Cell Diameter (MECD) is the maximum diameter that a cell can be expanded to. This value is

mathematically derived from the measured perimeter of a stent cell.

IC-215308-AG OCT2015 25 of 84

SYNERGY™ Stent Maximum Cell Diameter in Millimeters in Perspective

* Xience Alpine Stent 3.25 diameter utilizes the same platform as the 2.25 mm-3.00 mm diameters

Source: Data on File at Boston Scientific. n ≥ 3.

SYNERGY Stent_MECD_Technical _Report; PDM doc. 91019938


Diameter SYNERGY™

Stent

Proximal

End

MECD

SYNERGY

Stent Rest

of Body

MECD

Resolute

Integrity™

Stent

MECD

Resolute

Onyx™

Stent

MECD

Xience

Prime™,

Xpedition™,

Alpine™*

Stents

MECD

2.25 mm 2.3 mm 4.5 mm 7.6 mm 5.4 mm 4.5 mm

2.5 mm 2.3 mm 4.5 mm 7.6 mm 5.4 mm 4.5 mm

2.75 mm 2.3 mm 4.5 mm 7.6 mm 6.7 mm 4.5 mm

3.00 mm 2.7 mm 5.5 mm 5.2 mm 6.7 mm 4.5 mm

3.25 mm* N/A N/A N/A N/A 4.5 mm*

3.50 mm 2.7 mm 5.5 mm 5.2 mm 5.6 mm 5.4 mm

4.00 mm 2.9 mm 7.1 mm 5.2 mm 5.6 mm 5.4 mm

Maximum Expanded Cell Diameter (MECD) is the maximum diameter that a cell can be expanded to. This value is

mathematically derived from the measured perimeter of a stent cell.

IC-215308-AG OCT2015 26 of 84

SYNERGY

Stent

SYNERGY™ Stent

Stent Design + PtCr Alloy Combine for Greater Radial Strength

Bench testing performed by Boston Scientific Corporation. Data on file at Boston Scientific. All stents 2.50 mm; n ≥ 3. Bench test results not necessarily indicative of clinical performance.

Radial Strength: Amount of radial force required to reduce the diameter of a deployed stent by 15%

0.18

0.24

0.27 0.3

0.2

0.1

0.0

SYNERGY

Stent

Xience

Xpedition™,

Alpine™

Stents

Resolute

Onyx™

Stent

Rad

ial S

tren

gth

(N

/mm

)

Vs. Permanent Polymer DES

0.18 0.17

0.27

0.3

0.2

0.1

0.0

Orsiro™

Stent

Nobori™

Stent

Rad

ial S

tren

gth

(N

\mm

)

0.13

BioMatrix

Flex™ Stent

Str

on

ger

Vs. Other Bioabsorbable Polymer DES


SYNERGY™ Stent

Engineered to minimize recoil S

tro

ng

er


Stent Recoil: Amount the stent diameter reduces after deflation and removal of balloon

4.8%

4.3%

2.7%

6%

4%

2%

0%

SYNERGY

Stent

Resolute

Onyx™

Stent

Reco

il (

%)

5%

3%

1%

Nobori™Stent

2.7%

3.2%

2.3%

SYNERGY

Stent

BioMatrix

Flex™ Stent

3.3%

Orsiro™

Stent

6%

4%

2%

0%

Reco

il (

%)

5%

3%

1%

Less R

eco

il

Vs. Permanent Polymer DES Vs. Other Bioabsorbable Polymer DES


Xience

Xpedition™,

Alpine™

Stents

IC-215308-AG OCT2015 28 of 84

SYNERGY™ Stent

Outstanding Conformability

Str

on

ger


Conformability: The amount of torque required to bend the stent to a specific curvature

Nobori™

Stent

0.225

0.276

0.095

SYNERGY

Stent

BioMatrix

Flex™ Stent

0.374

Orsiro™

Stent

0.4

0.3

0.0

Co

nfo

rma

bilit

y (

N.m

m)

0.2

0.1

Mo

re C

on

form

ab

le

0.093

0.375

0.095

SYNERGY

Stent

Resolute

Onyx™

Stent

0.4

0.3

0.0

Co

nfo

rmab

ilit

y (

N.m

m)

0.2

0.1

Vs. Permanent Polymer DES Vs. Other Bioabsorbable Polymer DES


Xience

Xpedition™,

Alpine™

Stents

IC-215308-AG OCT2015 29 of 84

NEW Laser-Cut Hypotube

• ~300 cuts over

100 mm length

• Extends into midshaft

to exit port to improve

pushability

• Additional length maintains

midshaft flexibility

• ↑ Pushability and Flexibility

The graphic design does not represent actual vessel anatomy nor the actual size of the SYNERGY device. Data on file at Boston Scientific.

SYNERGY™ Stent System Improved Design for Superior Deliverability

PEBAX Dual-Layer Balloon

• Highly flexible

Bi-Segment™ Inner Lumen

• Proximal segment for push

• Distal segment for flexibility


581 548

522

472

200

300

400

500

600

SYNERGY Onyx Alpine Xpedition

1,02

1,05

1,13 1,13

0,9

1

1,1

SYNERGY Onyx Alpine Xpedition

SYNERGY™ Stent System Superior Deliverability1

Lo

wer P

rofile

Syste

m F

lex w

ith

Ste

nt

(N.m

m)

Pu

sh

(g/c

m)

Mo

re P

ush

ab

le

Cro

ssin

g P

rofi

le

(mm

)

Lesio

n E

ntr

y P

rofi

le

(mm

)

SYNERGY

Stent

System

Xience

Alpine™

Stent

System

Resolute

Onyx™

Stent

System

SYNERGY

Stent

System

SYNERGY

Stent

System

SYNERGY

Stent

System

Lo

wer P

rofile

M

ore

Fle

xib

le

Crossing Profile

System Flex Push

Lesion Entry Profile

1Based on bench testing. Lesion entry profile; 3.00 mm, n≥3. Crossing profile, system flex, and push; 3.00 mm, n ≥3. Bench testing performed by Boston Scientific. Results not necessarily

indicative of clinical performance. This material is not for use in the U.S., France or Japan.

0,43 0,45 0,46

0,49

0,3

0,4

0,5

SYNERGY Xpedition Alpine OnyxXience

Alpine™

Stent

System

Resolute

Onyx™

Stent

System

1,67 1,95 2,05 2,17

0

0,5

1

1,5

2

2,5

SYNERGY Onyx Alpine XpeditionXience

Alpine™

Stent

System

Resolute

Onyx™

Stent

System

Xience

Alpine™

Stent

System

Resolute

Onyx™

Stent

System

Xience

Xpedition™

Stent

System

Xience

Xpedition™

Stent

System

Xience

Xpedition™

Stent

System

Xience

Xpedition™

Stent

System

IC-215308-AG OCT2015 31 of 84

478

443

516

562

300

350

400

450

500

550

600

SYNERGY Nobori BioMatrix Flex Orsiro

0,44 0,45

0,47 0,47

0,40

0,45

0,50

SYNERGY Nobori Orsiro BioMatrix Flex

0,98 0,98

1,09

1,15

0,90

1,00

1,10

1,20

SYNERGY Orsiro Nobori BioMatrix Flex

SYNERGY™ Stent System Superior Deliverability1

Crossing Profile

System Flex Push

Lesion Entry Profile

1Based on bench testing. Crossing profile and lesion entry profile; 2.50 mm, n≥3. System flex and push; 3.00 mm, n≥3. Bench testing performed by Boston Scientific. Results not necessarily

indicative of clinical performance.

Cro

ssin

g P

rofi

le

(mm

)

Nobori™

Stent

System

SYNERGY

Stent

System

BioMatrix

Flex™ Stent

System

Pu

sh

(g/c

m)

Syste

m F

lex w

ith

Ste

nt

(N.m

m)

Lo

wer P

rofile

M

ore

Fle

xib

le

Lo

wer P

rofile

Mo

re P

ush

ab

le


Nobori™

Stent

System

SYNERGY

Stent

System

BioMatrix

Flex™ Stent

System

Orsiro™

Stent

System

1,67 1,99

2,37 2,4

0

0,5

1

1,5

2

2,5

SYNERGY BioMatrix Flex Orsiro NoboriNobori™

Stent

System

SYNERGY

Stent

System

BioMatrix

Flex™ Stent

System

Orsiro™

Stent

System

Lesio

n E

ntr

y P

rofi

le

(mm

)

Nobori™

Stent

System

SYNERGY

Stent

System

BioMatrix

Flex™ Stent

System

Orsiro™

Stent

System

Orsiro™

Stent

System

IC-215308-AG OCT2015 32 of 84

SYNERGY™ Stent System Exceptional Deliverability

63% 12%

7%

6%

3% 5% 4%

Total Procedure Time (Min)

< 30

31-40

41-50

51-60

61-70

71-90

>90

Data from SYNERGY Limited Market Evaluation Case Reports. Nov 2012 – May 2013. Boston Scientific data on file.

9%

27%

35%

29%

Lesion Type

A

B1

B2

C

In 500 cases during early evaluations in Europe, 2/3 procedures were

completed in less than 30 minutes


32%

61%

7%

Tortuosity

None

Moderate

Severe

IC-215308-AG OCT2015 33 of 84

SYNERGY™ Stent System Nominal and Rated Burst Pressures for DES

PRESSURES

Resolute Integrity™ Stent

System

Xience Xpedition™/ Alpine™

Stent Systems

2.25 – 2.50 mm

3.00 – 4.00 mm

ATM

kPa


System

2.25 – 2.75 mm

3.00 – 4.00 mm

4.00 mm

2.25 – 3.50 mm

SYNERGY Stent System

2.25 – 2.75 mm

3.00 – 4.00 mm

BioMatrix Flex™ Stent System 3.50 - 4.00 mm

2.25 – 3.00 mm

11

1115

15

1517

10

1013

9

912

8

811

16

1620

18

1827

17

1724

12

1213

13

1317

14

1420

6

608

Nobori ™ Stent System 3.50 - 4.00 mm

2.25 – 3.00 mm

Orsiro™ Stent System 3.50 - 4.00 mm

2.25 – 3.00 mm

*SYNERGY Stent, Promus PREMIER Stent, Xience Xpedition Stent, Resolute Integrity Stent, BioMatrix Flex Stent, Nobori Stent and Orsiro Stent DFU.


SYNERGY™ Stent System Labeled Post-Dilatation Limits*

*SYNERGY Stent, Promus PREMIER Stent, Xience Xpedition Stent and Resolute Integrity Stent DFU.

Xience Xpedition™

Stent System

Promus PREMIER™ Stent System

(mm) 3.00 3.50 3.75 4.00 2.75 2.50 2.25 4.25 4.75 5.00 5.25 4.50 3.25 5.50 5.75

Labeled Nominal:

Labeled Post-Dil Limit:

2.25

2.50 to 2.75

3.00 to 3.50

4.00

2.25 to 2.50

3.50 to 4.00

2.75 to 3.25


Stent System

2.25 to 2.75

3.00 to 4.00

SYNERGY

Stent System

2.25 to 2.75

3.00 to 3.50

4.00

Resolute Onyx™

Stent System 3.50 to 4.00

2.75 to 3.00

2.25 to 2.50


SYNERGY™ Stent System Low Stent and Tip Profile with Short Tip

Average

Stent Profile Tip Profile

Boston Scientific data on file. 2.50 mm stent systems tested. n = 3. Images by Boston Scientific. Bench test results may not necessarily be indicative of clinical performance.

0.017”

(0.44 mm)

0.020”

(0.53 mm)

(0.50 mm)

1.07 mm

1.06 mm

.01 mm

1.15 mm 0.018”

(0.47 mm)

1.09 mm 0.018”

(0.45 mm)

SYNERGY

Stent System


Stent System

BioMatrix Flex™

Stent System

Nobori™

Stent System

Orsiro™

Stent System 0.98 mm

0.018” (0.47 mm)

0.98 mm

7.5 mm

5.8 mm

8.2 mm

6.2 mm

5.2 mm

5.3 mm

6.1 mm

Xience Xpedition™

Stent System

Promus PREMIER™

Stent System 1.01 mm

1.09 mm

0.018” (0.46 mm)

0.018” (0.457 mm)


SYNERGY™ Stent System Compliance Chart (Inner Diameter*)

*See DFU for outer diameter. ** Rated Burst Pressure. DO NOT EXCEED

Pressure Stent I.D. (mm)

Atm - kPa 2.25 2.50 2.75 3.00 3.50 4.00

8 - 814 --- 2.35 2.57 2.89 3.3 3.81

9 - 910 2.13 2.42 2.65 2.96 3.4 3.91

10 - 1014 2.19 2.48 2.72 3.02 3.48 3.98

11 - 1117 2.24 2.54 2.79 3.08 3.55 4.06

12 - 1213 2.28 2.59 2.85 3.13 3.61 4.12

13 - 1317 2.31 2.63 2.89 3.17 3.66 4.17

14 - 1420 2.35 2.67 2.93 3.2 3.7 4.22

15 - 1517 2.37 2.7 2.96 3.24 3.74 4.26

16 - 1620 2.4 2.73 3 3.27** 3.79** 4.30**

17 - 1724 2.43 2.76 3.03 3.32 3.83 4.36

18 - 1827 2.45** 2.79** 3.06** 3.37 3.87 4.42

19 - 1924 2.48 2.82 3.1 3.43 3.93 4.52

20 - 2027 2.51 2.85 3.13 3.49 3.99 ---

21 - 2130 2.54 2.9 3.19 --- --- ---

22 - 2227 2.58 2.95 3.23 --- --- ---

NOMINAL RBP


1 SYNERGY Stent System, Promus PREMIER Stent System, Resolute Integrity Stent System Directions For Use. Resolute Onyx Stent System Directions for Use.

8 mm 9 mm 12 mm 14 mm 15 mm 16 mm 18 mm 20 mm 22 mm 24 mm 26 mm 30 mm 32 mm 34 mm 38 mm

2.25 mm

2.50 mm

2.75 mm

3.00 mm

3.50 mm

4.00 mm


2.25 mm

2.50 mm

2.75 mm

3.00 mm

3.50 mm

4.00 mm


2.00 mm

2.25 mm

2.50 mm

2.75 mm

3.00 mm

3.50 mm

4.00 mm


2.25 mm

2.50 mm

2.75 mm

3.00 mm

3.50 mm

4.00 mm

SYNERGY

Stent System

Promus

PREMIER™

Stent System

Resolute

Integrity™

Stent System

Resolute

Onyx™

Stent System

SYNERGY™ Stent System Size Matrix in Perspective1


1 SYNERGY Stent System, Promus PREMIER Stent System, Xience Xpedition Stent System and Xience Alpine Stent System Directions For Use. Xience Xpedition 48mm lengths source: dfu PPL2094732


2.25 mm

2.50 mm

2.75 mm

3.00 mm

3.50 mm

4.00 mm


2.25 mm

2.50 mm

2.75 mm

3.00 mm

3.25 mm

3.50 mm

4.00 mm


2.25 mm

2.50 mm

2.75 mm

3.00 mm

3.50 mm

4.00 mm

SYNERGY

Stent System

Promus

PREMIER™

Stent System

Xience

Xpedition™

Stent System

Xience

Alpine™

Stent System



8 mm 9 mm 12 mm 14 mm 15 mm 16 mm 18 mm 20 mm 23 mm 24 mm 28 mm 30 mm 32 mm 33 mm 38 mm 48 mm*

2.25 mm

2.50 mm

2.75 mm

3.00 mm

3.50mm

4.00 mm

IC-215308-AG OCT2015 39 of 84


SY

NE

RG

Y™

Ste

nt

Syste

m

8 mm 9 mm 11mm 12 mm 14 mm 15 mm 16 mm 18 mm 20 mm 22 mm 23 mm 24 mm 26 mm 28 mm 30 mm 32 mm 33 mm 34 mm 36 mm 38 mm

2.25 mm

2.50 mm

2.75 mm

3.00 mm

3.50 mm

4.00 mm

Bio

Matr

ix™

Ste

nt

N

ob

ori

™ S

ten

t

Ors

iro

™ S

ten

t


2.25 mm

2.50 mm

2.75 mm

3.00 mm

3.50 mm

4.00 mm

1 SYNERGY ™ Stent System, BioMatrix Stent System, Nobori Stent System and Orsiro Stent System Directions for Use.


2.25 mm

2.50 mm

2.75 mm

3.00 mm

3.50 mm

4.00 mm


2.25 mm

2.50 mm

2.75 mm

3.00 mm

3.50 mm

4.00 mm




Designed to Heal

Early Healing



Stented vessel is considered fully

healed when a continuous

endothelial layer covers the

neointimal layer

Finn AV, Joner M, Nakazawa G, et al. Pathological correlates of late drug-eluting stent thrombosis: strut coverage as a marker of endothelialization. Circulation 2007;115:2435– 41.

Joner M, Finn AV, Farb A, et al. Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk. J Am Coll Cardiol 2006;48:193–202.

Joner et al. Endothelial cell recovery between comparator polymer-based drug-eluting stents. J Am Coll Cardiol. 2008 Jul 29;52(5):333-42.

Pfisterer M, Brunner-La Rocca HP, Buser PT, et al. Late clinical events after clopidogrel discontinuation may limit the benefit of drug-eluting stents: an observational study of drug-eluting versus bare-

metal stents. J Am Coll Cardiol 2006;48:2584 –91.

Rodriguez AE, Mieres J, Fernandez-Pereira C, Vigo CF, Rodriguez-Alemparte M, Berrocal D, Grinfeld L, Palacios I. Coronary stent thrombosis in the current drug-eluting stent era: insights from the

ERACI III trial. J Am Coll Cardiol 2006;47:205–7

Tsimikas S. Drug-eluting stents and late adverse clinical outcomes lessons learned, lessons awaited. J Am Coll Cardiol 2006;47:2112–5

• Communicate

• Stabilize

• Prevent further neointimal formation

Healing Defined

Role of Endothelial Cell


18%

31%

0%

5%

10%

15%

20%

25%

30%

35%

Thin

strut

Thick

strut

Binary Restenosis

Thin

strut

Thick

strut

ISAR STEREO 2

Thin struts improve both acute performance

& clinical outcomes

Incid

ence R

ate

(%

)

The greater the initial injury to the vessel wall,

the more healing that needs to occur.

1 ISAR STEREO II JACC Vol. 41, No. 8, 2003 April 16, 2003:1283-8


Thin Stents

SYNERGY™ Stent

Thick Stents

ABSORB™ Stent

74 µm* (0.0029”) 150 µm (0.0059”)

% S

trut C

ove

rage

SYNERGY Stent 74 µm* (0.0029”)

ABSORB Stent 150 µm (0.0059”)

More red = More Thrombus Formation

13%

P = 0.002

n = 6 n = 6

28 days

Thinner Struts Provide More Rapid Healing1 and

Less Thrombus Formation2 in preclinical model

84%

Stent Design Factors Impacting Healing Strut Thickness

Uncovered struts predictive of late stent thrombosis 3

Thinner struts associated with reduced acute thrombogenicity2

1. Adapted from a poster presentation by Kazuyuki Yahagi, MD, Michael Joner, MD, and Renu Virmani, MD, TCT 2014. Rabbit Model; strut coverage measured at 28 days.

2. Adapted from a poster presentation by Oscar D. Sanchez, MD, Michael Joner, MD, and Renu Virmani, MD at TCT 2014. Ex vivo swine shunt model / 1 hour of circulation. Staining for

aggregate platelets (red).

3. Finn A, Joner M et al, Circulation 2007;115:2435-2441

* Strut thickness for small vessel model is 74μm, Workhorse model is 79μm and large vessel is 81μm. All trademarks are the property of their respective owners.

Thick Stents

BioMatrix™ Stent

120 µm (0.0047”)

n = 6

68%


Impact of Strut Thickness on Platelet Deposition

and Thrombus Formation

* ESS = Endothelial Shear Stress

Koskinas et al. JACC 2012;59:1337-49

Thick Strut DES

Thin Strut DES

Thinner struts reduce platelet deposition

*


IL-1β Levels

Fold

Dif

fere

nce

Rel

ativ

e to

PtC

r

PtCr PVDF MP35N

(CoNi)

L605

(CoCr)

Gold

3.0

2.5

2.0

1.5

1.0

0.5

0.0

(A)

* *

*

Cytokine Release After Exposure to Different

Stent Metal Surfaces in Cell Assay

PtCr platform associated with lowest inflammatory cytokine

response compared to other platform alloys

PtCr Surface Elicits Lowest Cytokine Response

Gold > L605 > MP35N > PtCr

TNF-α Levels

PtCr PVDF MP35N

(CoNi)

L605

(CoCr)

Gold

3.5

3.0

2.5

2.0

1.5

1.0

0.5

0.0

(B)

*

*

Fold

Dif

fere

nce

Rel

ativ

e to

PtC

r

6.0

5.0

4.0

3.0

2.0

1.5

1.0

0.5

0.0

Fold

Dif

fere

nce

Rel

ativ

e to

PtC

r

IL-8Levels

PtCr PVDF MP35N

(CoNi)

L605

(CoCr)

Gold

(C)

*

*

Presented by Dr. Granada TCT 2012


Polymer Impacts Healing Bare PtCr vs. Permanent Polymer Surface

Bare-Metal (PtCr) PtCr with

Conformal PVDF

More Dots

=

Better

Endothelialization

Bare-Metal (PtCr) PtCr with PVDF

0

50%

100%

7 Days 14 Days 7 Days 14 Days

% S

tru

t C

ove

rag

e

(% d

iffe

rence r

ela

tive to P

tCr)

p < 0.05

p < 0.05

1 Eppihimer, et al., Circ Cardiovasc Interv. 2013;6:370-377. Green dots represent VE-Cadherin Junctional Protein forming EC blood barrier; Blue dots represent EC nuclei

14 Days

Bare PtCr Provides Enhanced Endothelialization over

PtCr PVDF In Preclinical Model1


Direction of Drug Delivery and Polymer

Coating Design impact Healing

1 Presented by Mike Eppihimer (Boston Scientific), PhD, PCR 2014.

89 88 58 55 0

50

100

Conformal

Permanent

PVDF

Abluminal

Bioabsorbable

PLGA

21 Days

En

do

thelia

l C

ell

(EC

) C

ove

rage

(%

)

PtCr

BMS

Conformal

Bioabsorbable

PLGA

Mo

re E

nd

oth

eli

ali

za

tio

n

Bioabsorbable Abluminal Polymer/Drug Coating Significantly Improved

Endothelialization in Preclinical Model1


1 Adapted from presentations by Juan Granada, MD at TCT 2014 (and PCR 2014). Evaluated the Omega Bare Metal Stent. Preclinical: Diseased Porcine Model.

Polymer Type Impacts Healing Bioabsorbable vs. Permanent vs. Bare-Metal

SYNERGY Stent Reduces Early Inflammation Versus BMS and Late

Inflammation Versus Permanent Polymer Stents in a Preclinical Model1


SYNERGY™ OCT Results on All-Comers Patients 30 Days – 6 Months

1 Adapted from presentation by Ida Riise Balleby, MD at PCR 2015

2 Presented by J. M. de la Torre, MD at TCT 2014

3 Adapted from presentation by Juan Granada, MD, at CRT 2015

4 Adapted from a presentation by J. M. de la Torre, MD at PCR 2015

5. Finn, A. et al. Pathological Correlates of Late Drug-Eluting Stent Thrombosis Strut Coverage as a Marker of Endothelialization. Circulation. 2007;115:2435-2441.

SORT OUT VIII1

n = 30

(26% stents fully

covered)

SYNERGY2

n = 1

Burgos Santander4

3 month Cohort n = 22

Burgos Santander4

6 month Cohort n = 20

30 days

TIMELESS3

n = 37

2 Months 6 Months

72.2% Covered 100% Covered 85.6% Covered 94.2% Covered 96.3% Covered

3 Months

Excellent Stent Strut Coverage in Multiple OCT Analysis 30 Days - 6 Months

Stents with <70% coverage were a significant predictor

(9-fold increase risk) for late stent thrombosis.5


SORT OUT VIII – OCT Substudy (All-Comers)

30 Day Results

1 Holm, N. MD TCT 2014.

72,2% 64,3%

0%

25%

50%

75%

P=0.09

Perc

enta

ge o

f

Covere

d S

truts

BioMatrix™

Stent

(n=33)

SYNERGY

Stent

(n=31)

6,0%

26,0%

0% 25% 50%

SYNERGY Stent

(n=31)

BioMatrix Stent

(n=33)

P= not reported

SYNERGY

OCT Image:

All comers

patient1

% of the patient’s lesions covered >95% Median % of Covered Struts

7,1%

2,3% 2,3%

4,7%

2,3%

0% 0% 0% 0% 0% 0,0%

4,0%

8,0%

MACE TLR MI Cardiac

Death

Stent

Thrombosis

BioMatrix™

Stent

(n=42)

SYNERGY

Stent

(n=38)

Incid

ence R

ate

(%

)

Adapted from presentation by Ida Riise Balleby, MD at PCR 2015.

The SYNERGY™ Stent showed a trend towards more complete early strut

coverage compared to the BioMatrix Stent


SYNERGY™ Stent Early Healing in Human – 2 Months

“SYNERGY Stent, a complete and smooth coverage was observed over all struts at 2 months.” Dr. de le Torre

SYNERGY Stent

Presented by J. M. de la Torre, MD at TCT 2014

OCT Confirms Complete Coverage at 2 Months


TIMELESS – OCT Analysis (All-Comers) 3 Month Results

Adapted from presentation by Juan Granada, MD, at CRT 2015

85,6%

0%

25%

50%

75%

100%

Pe

rcen

tage o

f

Cove

red

Str

uts

SYNERGY

Stent

(n = 37)

Clinical Events at 3 Months Median % of Covered Struts at 3 Months

0% MACE and ST Reported

Real World Patients Evaluated

Patient and Lesion

Characteristics

Number of Patients 37

Diabetes 27%

Hypertension 62%

Stable Angina 35%

Acute Coronary

Syndrome

57%

% B2/C Lesions 42.9%

The SYNERGY™ Stent showed a trend towards complete

strut coverage at 3 months in an all-comers study


Burgos-Santander Early OCT in SYNERGY™ Study Study Design and Patient Characteristics

IC-3

3800

1-A

A S

EP

T20

15

Patient Characteristics

Burgos Cohort: 3 Months OCT (22 Patients)

Santander Cohort: 6 Months OCT (20 Patients)

Spain

Adapted from a presentation by Jose Maria de la Torre, MD at PCR 2015.

OCT study evaluated patients at 3 months and 6 months

Burgos

Cohort

3 Months

Santander

Cohort

6 Months

P-value

Number of Patients 22 20 0.7

Diabetes 36.3% 35% 0.8

Hypertension 54.5% 45% 0.7

Stable Angina 27.2% 35% 0.8

Acute Coronary

Syndrome

72.7% 65% 0.8


Burgos-Santander Early OCT in SYNERGY™ Study 3 and 6 Month OCT Results

94.2% 96.3% % of Stent

Struts Covered:

n = 30 Stents n = 30 Stents

Burgos Cohort 3 Months

Santander Cohort 6 Months

Adapted from a presentation by Jose Maria de la Torre, MD at PCR 2015.

The SYNERGY Stent OCT Images show nearly complete

strut coverage as early as 3 months




Designed to Heal

Early Healing



SYNERGY™ Stent Clinical Program


EVOLVE Clinical Trial Design and Methods

Per protocol patients were treated with clopidogrel, ticlopidine or prasugrel for at least 6 months following the index procedure

SYNERGY™ Stent n = 94

SYNERGY Stent ½ Dose n = 99

PROMUS Element™ Stent n = 98

Patients with de novo native coronary lesions ≤ 28 mm in length, RVD ≥2.25 mm ≤ 3.5, %DS>50 (excluded LM disease, CTO, AMI or recent MI)

Single-blind, noninferiority design

Primary Clinical Endpoint: TLF (TV-CD, TV-MI, or TLR) at 30 days

Primary Angiographic Endpoint: In-stent late loss at 6 months

Randomized 1:1:1 at 29 sites

(Europe, Australia, New Zealand)

Presented by Ian T. Meredith AM, MBBS, PhD, PCR 2015.


EVOLVE Clinical Trial Primary Endpoint: 6-Month Angiographic Results

Meredith et al J Am Coll Cardiol. 2012;59(15):1362-70

*Only the “full dose” SYNERGY Stent results are shown.

PROMUS Element™ Stent

(n = 98)

SYNERGY Stent*

(n = 94)

0.10

0.15

0.20

0.15

0.10

0.05

0.00

Incid

en

ce R

ate

(m

m)

In-Stent Late Loss (mm)

p (non-inf.) < 0.001

P (sup) = 0.19

EVOLVE Trial

Primary endpoint met: SYNERGY Stent was

non-inferior to PROMUS Element™ Stent


Presented by Ian T. Meredith AM, MBBS, PhD, PCR 2015. Only the “full dose” SYNERGY Stent results are shown.

All Target Vessel MI were NQWMI for both the SYNERGY and PROMUS Element Stents

*One NQWMI in the SYNERGY group was periprocedural. The remaining 2 NQWMI in the SYNERGY arm were considered unrelated to the study device: one at day 347 due to anemia and a

major GI bleed, and one at day 364 subsequent to respiratory failure in a patient with severe COPD – enzymes were checked indicating that a NQWMI had occurred. The one death was of an

unknown cause at day 472 and adjudicated as a Cardiac Death. Safety Population. All p-values are >0.05.

8,4

5,5 6,1

1,1

3,3 3.3*

1,1

0

2

4

6

8

10

Incid

en

ce

Rate

(%

)

COMPONENTS OF TARGET LESION FAILURE (TLF)

PROMUS Element™ Stent (n = 98) SYNERGY™ Stent (n = 89)

TLF TLR Target Vessel

MI

Target Vessel

Cardiac Death

ARC ST

(Def/Prob)

0 0 0

EVOLVE Clinical Trial 4-Year Clinical Results

0% ARC Stent Thrombosis (ST) (Definite/Probable)

1.1% Target Lesion Revascularization (TLR)


EVOLVE Clinical Trial 4-Year TLR Results

Presented by Ian T. Meredith AM, MBBS, PhD, PCR 2015 Only the “full dose” SYNERGY Stent results are shown.

Numbers

at risk

PROMUS

Element™

Stent

Incid

en

ce R

ate

(%

)

6 Month

protocol-required

angiogram

6.1

1.1

P = 0.07

98 98 93 92 64

92 90 87 84 59 SYNERGY

Stent

No additional TLR from 6 Months to 4 Years with the SYNERGY™ Stent


20

0

0 1 2 3 4 Years

IC-215308-AG OCT2015 61 of 84

EVOLVE II Clinical Trial Design First Successful U.S. Pivotal Trial of a Bioabsorbable Polymer Technology

Randomized Cohort (RCT)

SYNERGY™ Stent

n = 846

PROMUS Element™ Plus

Stent System

n = 838

RCT Design Multicenter noninferiority trial

Pivotal, single-blind, 1:1 randomization

Primary Endpoint: TLF (CD, TV-MI, or TLR)

at 12 months Follow-up through 5 years

Patients with ≤3 native coronary artery lesions in ≤2 major epicardial vessels; lesion length ≤34 mm, RVD

≥2.25 mm ≤4.0, %DS> 50 <100 (excluded LM disease, SVG, CTO, ISR or recent STEMI)

SYNERGY

Stent

n = 21

Diabetes

Substudy

PK

Substudy

125 global sites Single-arm

Diabetes Study

n = 203

SYNERGY

Cohort

EVOLVE II RCT

n = 263

EVOLVE II Diabetes Substudy Design

Consecutive, multicentre, single-arm, non-

randomised

1° Endpoint: TLF at 12 mo

Kereiakes et al. The EVOLVE II Trial. Circ Cardiovasc Interv. 2015.

EVOLVE II DM Substudy. Presented by Stephan Windecker, MD at PCR 2015.wing the index procedure.

Per protocol, patients were treated with one of the following P2Y12 inhibitors (clopidogrel, ticlopidine, prasugrel, or ticagrelor) for at least 6 months follow up

Most complex patient population ever studied in a U.S. Pivotal Trial


EVOLVE II Clinical Trial Baseline Patient Characteristics – A More Comers Study


SY

NE

RG

Y™

Ste

nt A

rm

Po

pu

latio

n (

%)

25,9

33,9

76,8

23,9

31,1

0

20

40

60

80

NSTEMI Unstable Angina B2/C Lesions <2.25 mm DM MedicallyTreated

Broadest and most complex patient population

ever studied in a U.S. Pivotal Trial


96,9

98,3

90

100

PROMUS Element™ Plus Stent System

SYNERGYStent System


1 Technical Success is defined as successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization, and post-procedure diameter

stenosis of <30% in 2 near-orthogonal projections with TIMI 3 flow in the target lesion, as visually assessed by the physician. Summarized per lesion

EVOLVE II Clinical Trial SYNERGY™ Stent System Technical Success

(n = 838) (n = 846)

P = 0.04

Te

ch

nic

al S

ucce

ss (

%)

SYNERGY Stent displayed greater technical success1 with delivery and deployment


6,4

4,7

1,7

0,9

6,4

4,3

2,6

0,5

0,0

5,0

10,0

TLF Target Vessel MI Target Lesion Revascularization (TLR) Cardiac Death

EVOLVE II Clinical Trial 1-Year Results

Kereiakes et al. The EVOLVE II Trial. Circ Cardiovasc Interv. 2015. 1684 patients were randomized 1:1 to SYNERGY or PROMUS Element Plus Stent Systems. Graph shows TLF Per Protocol (PP)

and MI, TLR, CD shown for the Intent-to-Treat (ITT) population. ITT TLF for SYNERGY Stent = 6.7%. and for PROMUS Element Stent = 6.4% respectively (p=0.0005 for non-inferiority).

1 TLF: ischemia-driven TLR, MI related to the target vessel, or any cardiac death. The study primary endpoint was the rate of 12-month TLF by both intent-to-treat and per-protocol analyses.

2 Per protocol spontaneous MI is defined as rise and/or fall of cardiac biomarkers with ≥1 value >99th percentile of the URL + evidence of myocardial ischemia. Peri-PCI Mi is defined as ≥1 of the

following: i) biomarker elevations within 48 hours of PCI (based on CK-MB >3X URL), ii) new pathological Q waves, or iii) autopsy evidence of acute MI

P = 0.34 P = 0.21 P = 0.71

SYNERGY™ Stent System Promus Element™ Plus Stent System

Incid

en

ce R

ate

(%

)

Components of TLF

2

pnoninf =0.0003

P=0.99

Primary Endpoint of Target Lesion Failure1 (TLF) Met


SYNERGY Stent

PROMUSElement Plus Stent

System


*One of the SYNERGY acute ST events involved a patient who was not treated with pre-procedural aspirin

^Occurred on day 6. ST rates were equivalent when analyzed in an intent-to-treat or per protocol manner.

Subacute (2-30 days) Late (30 days – 1 year)

0.6%

(n = 5)

0.4%

(n = 3)

P = 0.50

Acute (≤1 day)

n = 1** (probable)

n = 5 (2 definite/3 probable)

n = 2* (definite)

TM

EVOLVE II Clinical Trial Exceptionally Low Stent Thrombosis

ZERO definite ST events in SYNERGY™ arm after 24 hours


EVOLVE II Diabetes Substudy Primary Endpoint 12-Month TLF

7,5

0

5

10

15

20

ITT

Targ

et L

esio

n F

ailu

re,

%

Performance Goal = 14.5%

1-sided

97.5% UCB*

P<0.0001 In

cid

en

ce R

ate

(%

)

P-value from the one-sided Clopper-Pearson test is <0.025, the 12-month TLF rate from SYNERGY is concluded to be less than the performance goal (14.5%)

*One-sided 97.5% Clopper Pearon Upper Confidence Bound (UCB)

Target lesion failure (TLF) defined as: Cardiac death, or MI related to the target vessel (based on CK-MB >3x URL), or Ischemia-driven target lesion revascularization

EVOLVE II DM Clinical Trial. Presented by Stephan Windecker, MD at PCR 2015.

Primary Endpoint of TLF was Met


Cutlip et al, Circulation. 2007; 115(17):2344;

• Spontaneous MI was defined as the rise and/or fall of cardiac biomarkers with ≥1 value >99th percentile of the upper reference limit (URL) with ≥1 of the following: symptoms of ischemia, ECG

changes, and or evidence of loss of myocardium. Peri-PCI MI was defined by any of the following: i) CK-MB >3X URL within 48 hours, ii) new pathological Q waves, iii) autopsy evidence. All ST

were definite.

• EVOLVE II DM Clinical Trial. Presented by Stephan Windecker, MD at PCR 2015.

1,3 0,4

5,5

7,5

4,4

1,1

0

5

10

15

All

Death

QWMI* Non-

QWMI*

Target Lesion

Failure (TLF)

ARC ST

(Def/Prob)^

Incid

en

ce R

ate

(%

)

Target Lesion

Revascularization

(TLR)

N=466

EVOLVE II Diabetes Substudy 12-Month Clinical Results

Acute (≤ 1 day) 0.9%

Subacute (2-30 days) 0.2%

Late (31-365 days) 0%


BSC is Supporting Research of the SYNERGY™ Stent Studying approximately 15,000 patients

“The SYNERGY stent is an investigational device and not for sale in the US. CE Mark Approved 2012. “Boston Scientific is not responsible for the collection, analysis or reporting of the

investigator-sponsored research output which is the sole responsibility of the investigators. Boston Scientific’s involvement in investigator-sponsored research is limited to providing financial support

for research that advances medical and scientific knowledge about our products. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with

each device. The SYNERGY™ stent is an investigational device and not for sale in the US.”

2 The Greek Platelet study is investigating platelet gene expression and protein levels of α2A-ARs and α2B-ARs in pts. with CAD compared to healthy pts., before and after stent implantation. It is

not evaluating DAPT duration. This material is not for use in the U.S., France or Japan. IC-215308-AG OCT2015 69 of 84

Adapted from Presentation by Stefan James, MD at TCT 2015

SYNERGY™ Stent reported lowest rates of ST in

real-world SCAAR registry

SCAAR October 2015 Stent Thrombosis (%) in Drug-Eluting Stents


Cumulative risk of stent thrombosis in individual stent types beyond 1-Year

*The risk of Stent thrombosis is based on the Kaplan Meier Estimate. For the Ultimaster stent only 9 stent thromboses were reported in 1156 stents. Eight of these in one hospital.

*

*

De

fin

ite

Ste

nt th

rom

bo

sis

(%

)

Time

Ultimaster™ Stent N=1,156

Resolute Integrity™ Stent N=26,235

Xience Xpedition™ Stent N=12,258

Orsiro™ Stent N=5,814

BioMatrix™ Stent N=3,176

Resolute Onyx™ Stent N=6,422

Promus PREMIER™ Stent N=20,393

SYNERGY™ Stent N=7,880

All stents 2007-Oct. 1, 2015

Unadjusted

1.5

1.0

0.5

0.0

0

1

2

3

4

5

IC-215308-AG OCT2015 70 of 84

Survey of ICs support SYNERGY™ Stent showing operational efficiencies

1. Data on File at Boston Scientific. 26 total respondents identified themselves as SYNERGY users from Europe. Based on their experience, they estimated that SYNERGY’S visibility and

deliverability reduced contrast used in a typical PCI compared to other non-PtCr stents by an average of 10%. Average is all users.

2. Data on File at Boston Scientific; 26 total users identified themselves as SYNERGY users from Europe. Based on their experience, we asked “In the last 90 days, has SYNERGY’s deliverability

allowed you to treat additional cases with PCI where the patient would have otherwise gone to surgery or medical management?” We then asked them to quantify by asking: “How many additional

cases in the last 90 days has SYNERGY’s deliverability allowed you to treat with PCI where the patient would have otherwise gone to surgery or medical management?“ The average was 5.2

cases in the past 90 days.

3. Data on File at Boston Scientific. 26 total users identified themselves as SYNERGY users from Europe. Based on their experience, they estimated that SYNERGY’s visibility and deliverability

reduced radiation exposure to the patient and staff in a typical PCI compared to other non-PtCr stents by an average of 2.5 minutes of all users.

4. US IC Blinded Product Perception survey (62 ICs), Increased stent visibility was estimated to decrease stent usage by 14% and balloon usage by 18% during a typical PCI and 5 minutes less

procedure time in IC Perception survey; 95% (59/62) identified the PtCr stent as the most visible.

In a survey of European SYNERGY users,

in a typical PCI as compared to other DES,

SYNERGY users believe SYNERGY

provides the following efficiencies:

In a blinded perception study about

SYNERGY’s visibility, respondents believed

that SYNERGY’s Platinum Chromium could

provide the following efficiencies:

10% reduced

contrast/procedure1

5 Additional cases

delivered in past

90 days2

3 Minutes of

reduced

radiation/procedure3

14% less

stent usage4

18% less

balloon usage4

5 minutes

of reduced

procedure time4


SYNERGY™ Stent System Summary

Thin Abluminal

Coating


1 Wilson, G.J., et al. Catheter Cardiovasc Interv. 2015. 2 OCT Analyses: SORT OUT VIII - Adapted from presentation by Ida Riise Balleby, MD at PCR 2015; OCT Analysis presented by J. M. de la Torre, MD at TCT

2014; TIMELESS - Adapted from presentation by Juan Granada, MD, at CRT 2015; Burgos-Santander Study - Adapted from a presentation by J. M. de la Torre, MD

at PCR 2015. 3 US IC Blinded Product Perception survey (62 ICs), Increased stent visibility was estimated to decrease stent usage by 14% balloon usage by 18% during a typical

PCI and 5 minutes less procedure time in IC Perception survey; 95% (59/62) identified

the PtCr stent as the most visible.

SCAAR October 2015 Stent Thrombosis (%) in Drug-Eluting Stents

Providing operational efficiency, optimal healing, and freedom from

long-term polymer exposure

• SYNERGY™ Stent offers peace of mind

knowing that the polymer is gone shortly after the

drug is completely eluted at 3 months1

• SYNERGY Stent has shown full stent strut

coverage as early as 30-days in humans and

showed 0% stent thrombosis in multiple OCT

analyses.2

• Unmatched acute performance which reduces

procedure time as much as 5 minutes per case.3

IC-215308-AG OCT2015 72 of 84

Back-Up


Lesion entry profile 0.017 inch (0.44 mm)

Average stent profile* 0.039 inch (0.98 mm)

Total catheter length 144 cm

Distal shaft coating Bioslide™ hydrophilic coating

Hypotube coating PTFE

SDS shaft outer diameter ≤0.80 mm (2.1 F) proximally and 2.7F or 2.8F** (≤ 0.95 mm) distally

Guide catheter compatibility 5 F (≥0.056”, 1.42mm)

Delivery system ports Single access port to inflation lumen.

Guide wire exit port located 25 cm from tip.

Designed for guidewire ≤ 0.36 mm (0.014 inch)

Balloon material PEBAX

Balloon fold 5 wings

Marker band material Platinum Iridium

Marker band length 1 mm

Marker band placement Nominally spaced 0.39 mm away from the end of the stent

SYNERGY™ Stent Delivery System Key SDS Specifications

Tip Profile

0.017 inch

(0.44 mm)

Avg. Stent Crossing Profile

0.039 inch (0.98mm) Smaller Distal Outer

2.6F

Proximal Outer

2.1F

Dual-Layer

PEBAX® Balloon Laser-cut Hypotube PTFE-coated Hypotube


SYNERGY™ Stent System Available Sizes

8 mm 12 mm 16 mm 20 mm 24 mm 28 mm 32 mm 38 mm

2.25 mm

2.50 mm

2.75 mm

3.00 mm

3.50 mm

4.00 mm

SYNERGY Stent System 2.25 x 38 mm 96 codes (MR/OTW)

Identical size matrix as Promus PREMIER™ Stent + 2.25 x 38 mm


Synchrony™ Bioabsorbable Coating Unique Synchronized Drug Elution and Polymer Absorption

Less than half the polymer is needed to deliver a similar drug dose to Promus PREMIER™ Stent

Color-enhanced FESEM image showing the

microstructure of the Synchrony

Bioabsorbable Coating

Drug-rich

layer

Drug-rich

domain

Polymer -

rich matrix

Factors

affecting

absorption time

SYNERGY’s PLGA

Polymer

PLA/PLLA

Polymers

Hydrophilicity High Glycolic content

results in accelerated

absorption time

No Glycolic

component

Morphology 100% amorphous

structure facilitates

absorption

Semi-crystalline

structure makes

absorption more

difficult and take

longer

Boston Scientific data on file.

SYNERGY™ Stent’s PLGA Polymer is hydrophilic and 100% amorphous

making it easier for the body to absorb compared to PLA/PLLA polymers


SYNERGY™ Stent Abluminal Coating

Arterial Wall

Promus PREMIER™ Stent Conformal Permanent Polymer

SYNERGY Stent Abluminal PLGA

Bioabsorbable Polymer 74 µm*

81 µm


EVOLVE Lesion Characteristics in Perspective

Po

pu

latio

n (

%)

53,6% 56,0%

0%

20%

40%

60%

B2/C

ACC/NCDR SYNERGY Stent

1 Meredith I, et al JACC, 2012:1362–70.

2 Krone et al, Am J Cardiol 2003;92: 389-394 ; The ACC/NCDR Registry assesses the characteristics, treatments and outcomes of patients receiving diagnostic catheterization and/or PCI.

SYNERGY™ Stent1 EVOLVE Trial %B2 /C Lesion classifications

comparable to ACC/National Cardiovascular Data Registry (NCDR)2


Cardiac Biomarkers Background

Description

CK

(Creatine Kinase)

Enzyme found in both cardiac and skeletal muscle

Release into blood signifies muscle damage and cell death

Elevations can signify injury to cardiac muscle or skeletal muscle

CK-MB

(Creatine Kinase-

Myocardial Band)

Found to a much greater extent in cardiac muscle compared to skeletal muscle

Elevations suggestive of injury to cardiac muscle

Very sensitive for detecting MI (though not as sensitive as troponin)

Small elevations following PCI may have little clinical significance

Cardiac

Troponin

Cardiac troponin I or T are frequently measured

These proteins are essentially found only in cardiac muscle

Most sensitive markers of MI

Small elevations following PCI may have little clinical significance

Several Different Biomarkers Can Be Used to Detect Myocardial Damage


The EVOLVE definitions for MI were as follows:

• Myocardial infarction was defined as either the development of new pathological Q waves in 2 leads (duration 0.04 s) with

elevated levels of creatine kinase-myocardial band (CK-MB) or troponin; or, in the absence of new Q waves

• Elevation of CK 3 times normal (periprocedural MI, occurring within 48 h of the procedure) or 2 times normal

(spontaneous MI) with elevated CK-MB, or troponin 3 times normal (periprocedural MI) or 2 times normal (spontaneous MI),

plus any 1 of the following: 1) electrocardiographic changes indicative of new ischemia (new ST-T changes or left bundle

branch block); 2) imaging evidence of new loss of viable myocardium; or 3) new regional wall motion abnormality.

The EVOLVE II definitions for MI were mandated by the FDA and are as follows:

• Per protocol spontaneous MI is defined as rise and/or fall of cardiac biomarkers with ≥1 value >99th percentile of the URL +

evidence of myocardial ischemia.

• Peri‐PCI MI is defined as ≥1 of the following: i) biomarker elevations of CK-MB >3x URL within 48 hours of PCI, ii) new

pathological Q waves, or iii) autopsy evidence of acute MI

EVOLVE and EVOLVE II Trial Complete MI Definitions

The MI rate in the EVOLVE II Study based on the study’s MI definitions was 4.7% for PROMUS Element™

Stent and 4.3% for the SYNERGY™ Stent. Most MIs were peri-procedural Non-Q-wave events utilizing this

more sensitive MI definition, and there were no additional clinical sequelae in these patients through 30

days follow-up.


EVOLVE II Trial NQWMI and QWMI Data

4,7 4,5

0,2

4,3 4,1

0,2 0,0

5,0

10,0

Target Vessel MI Target Vessel NQW MI Target Vessel QW MI

EVOLVE II Clinical Trial presented by Dean Kereiakes, MD at AHA 2014. 1684 patients were randomized 1:1 to SYNERGY or PROMUS Element Plus Stent Systems. Graph shows MI rates per the

Intent-to-Treat (ITT) population. The SYNERGY Stent is an investigational device and not for sale in the U.S. or Japan.

1 Per protocol spontaneous MI is defined as rise and/or fall of cardiac biomarkers with ≥1 value >99th percentile of the URL + evidence of myocardial ischemia. Peri-PCI Mi is defined as ≥1 of the

following: i) biomarker elevations within 48 hours of PCI (based on CK-MB >3X URL), ii) new pathological Q waves, or iii) autopsy evidence of acute MI

SYNERGY™ Stent System Promus Element™ Plus Stent System

P = 1.00 P = 0.71 In

cid

en

ce R

ate

(%

) P = 0.71

1

Majority of Target Vessel MI was attributed to Peri-procedural NQWMI

• The EVOLVE II Clinical Trial

utilized a more sensitive MI

definition1 relying principally

on a cutoff of CK-MB > 3x

ULN

• This definition detected mild

periprocedural elevations -

generally not considered

clinically significant

• The trial patient population

included:

• 25% NSTEMI patients

• >75% B2/C lesions

• Even in this complex patient

population, both products

demonstrated outstanding

results

n = 838 n = 838


MI Rates Based on CK-MB >3x ULN Definition1

17,9%

5,3% 6,8% 6,6% 7,1%

6,1% 4,7% 4,3%

0%

5%

10%

15%

20%

WashingtonHospital

Acuity BVS StentABSORB III

Xience StentABSORB III

BVS -ABSORB II

Xience -ABSORB II

PE -EVOLVE II

SYNERGY -EVOLVE II

Results from different studies are not directly comparable. Information provided for educational purposes only.

1. Per EVOLVE II protocol spontaneous MI is defined as rise and/or fall of cardiac biomarkers with ≥1 value >99th percentile of the URL + evidence of myocardial ischemia. Peri‐PCI MI is

defined as ≥1 of the following: i) biomarker elevations within 48 hours of PCI (based on CK‐MB >3X URL), ii) new pathological Q waves, or iii) autopsy evidence of acute MI.

2. Stone, G MD, et al. Differential Impact on Survival of Electrocardiographic Q-Wave Versus Enzymatic Myocardial Infarction After Percutaneous Intervention. Circulation: 2001: 104: 642-

647.

3. Prasad A. MD, et al. Prognostic Significance of Periprocedural Versus Spontaneously Occurring Myocardial Infarction After Percutaneous Coronary Intervention in Patients With Acute

Coronary Syndromes An Analysis From the ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) Trial JACC 2009;54:477-486.

4. ABSORB III Presented by Dean J. Kereiakes, MD at TCT 2015

5. ABSORB II Presented by Patrick W. Surreys, MD at TCT 2014

6. Kereiakes et al. The EVOLVE II Trial. Circ Cardiovasc Interv. 2015

Washington

Hospital Center2

(n = 7,147)

BVS Stent

ABSORB II5

(n = 324)

ACUITY3

(n = 7,773)

BVS Stent

ABSORB III4

(n = 1,322)

Xience Stent

ABSORB III4

(n = 686)

Xience Stent

ABSORB II5

(n = 163)

PROMUS

Element™ Stent

EVOLVE II6

(n = 838)

SYNERGY™

Stent

EVOLVE II6

(n = 838)

P = 0.69 P = 0.71

B2/C-45.5% B2/C-49.4% B2/C-74.3% B2/C-76.8% B2/C-tbd B2/C-tbd B2/C-68.7% B2/C-72.5%

Incid

en

ce R

ate

(%

)

Event Rates Across Multiple Studies


P = 0.89

IC-215308-AG OCT2015 82 of 84

SYNERGY™ Stent System Balloon Overhang Bench Test Comparison

IC-338001-AA SEPT2015

Testing Completed by Boston Scientific. Data on file. 2.5 mm x 28 or 30 mm stent products tested. n=3. Bench test results may not necessarily be indicative of

clinical performance.

Negative overhang High Overhang (>2.0mm)

Balloon Overhang

Measurements (mm)

n=3

SYNERGY™

Stent

PROMUS

Element™

Plus Stent

Xience

Prime™

Stent

Resolute

Integrity™

Stent

Nobori™

Stent

BioMatrix

Flex™

Stent

Orsiro™

Stent

Distal overhang

at 11 ATM 0.37 0.44 0.58 1.17 0.79 1.47 -0.30

Proximal overhang

at 11 ATM 0.68 0.49 0.60 0.15 1.22 1.13 0.49

Total overhang

at 11 ATM / 1117 kPa 1.05 0.93 1.18 1.32 2.01 2.60 0.19

Distal overhang

at 18 ATM 0.40 0.53 0.57 1.75 1.31 1.69 -0.22

Proximal overhang

at 18 ATM 1.00 0.58 0.69 -0.27 1.63 1.23 0.71

Total overhang

at 18 ATM / 1827 kPa 1.40 1.12 1.25 1.48 2.94 2.92 0.49

Minimal Balloon Overhang to help Minimize Vessel Trauma


Glossary

CAUTION: Law restricts this device to sale by or on the order of a physician. Indications,

contraindications, precautions, and warnings can be found with product labeling supplied

with each device. Information for the use only in countries with applicable health authority

product registrations. Information herein not intended for distribution in France.

SYNERGY is an unregistered or registered trademark of Boston Scientific Corporation or

its affiliates. All other trademarks are the property of their respective owners.

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


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