BVS: History & Current Limitations

Richard J Rapoza, PhD Divisional Vice President, R&D

Product and Therapy Innovation Abbott Vascular

Absorb is authorized for sale in CE Mark and certain independently regulated countries outside the United States.

Please check the regulatory status of the device in your geographic location prior to distribution.

Not to be reproduced, distributed or excerpted. ©2013 Abbott. All rights reserved AP2939100-OUS Rev. A 10/13 2

Balloon

Angioplasty

(PTCA)

Bare

Metal Stents

(BMS)

Coronary Drug

Eluting Stents

(DES)

XIENCE

Durable

Polymer

DES

Absorb

Fully

Bioresorbable

Vascular

Scaffold (BVS)

Advancements in PCI

With Every Evolution There is a Learning Curve

Absorb is authorized for sale in CE Mark and certain independently regulated countries outside the United States.

Please check the regulatory status of the device in your geographic location prior to distribution.

Not to be reproduced, distributed or excerpted. ©2013 Abbott. All rights reserved AP2939100-OUS Rev. A 10/13 3

The Absorb Bioresorbable Vascular Scaffold

Note: the struts are not visible under fluoroscopy. Photos taken and data on file at Abbott Vascular.

Markers on

back side

of scaffold

0.7 mm

There are two pairs of platinum marker beads – one pair at each end of the scaffold

Each end of the scaffold is aligned with markers on the delivery catheter

– Scaffold markers lie

near the inner edge of

each marker on the

delivery catheter

Absorb is authorized for sale in CE Mark and certain independently regulated countries outside the United States.

Please check the regulatory status of the device in your geographic location prior to distribution.

Not to be reproduced, distributed or excerpted. ©2013 Abbott. All rights reserved AP2939100-OUS Rev. A 10/13 4

Expansion Limits Must be Respected

When expanding the scaffold, be sure to stay within the expansion limits of the device:

Nominal

Scaffold Diameter

CAUTION

Do not dilate the scaffold beyond the maximum dilatation limit.

Expansion beyond the dilatation limits listed above, may result in scaffold damage.

2.5 mm

3.0 mm

3.5 mm

3.00 mm

3.50 mm

4.00 mm

Maximum

Dilatation Limit

This is consistent with the Absorb IFU, Section 10.7

Absorb is authorized for sale in CE Mark and certain independently regulated countries outside the United States.

Please check the regulatory status of the device in your geographic location prior to distribution.

Not to be reproduced, distributed or excerpted. ©2013 Abbott. All rights reserved AP2939100-OUS Rev. A 10/13 5

3.0 mm 3.1 mm 3.0 mm 2.8 mm

Actual OCT IVUS QCA

Visual

Estimate

2.7 – 3.3 mm

over-estimates under-estimates inter/intra-observer

variability

Margin of Error*

Use pre-dilatation to help guide and confirm vessel size

Proper Vessel Sizing

Limitations of Various Vessel Sizing Techniques

*Margin of error estimates based on resolution for each imaging modality: Resolution of OCT and IVUS:

Bezerra, H.G., J Am Coll Cardiol.: Cardiovasc Interv. 2009; 2: 1035. Resolution of QCA: Dahm, J. and van

Buuren, F. Int J Vasc Med. 2012. Offset and variability of visual estimate: data on file at Abbott Vascular.

Recognize risk of underestimating vessel size by visual estimation

Absorb is authorized for sale in CE Mark and certain independently regulated countries outside the United States.

Please check the regulatory status of the device in your geographic location prior to distribution.

Not to be reproduced, distributed or excerpted. ©2013 Abbott. All rights reserved AP2939100-OUS Rev. A 10/13 6

X-Ray Considerations on Polymeric Scaffolds

• Radiopaque metallic stents may enhance the

contrast density at the lumen edges

X-ray

Path

The treated segment may appear slightly smaller than it actually is, simply due to non-radiopaque struts reducing contrast density

Images are artistic renderings and not to be considered engineering drawings.

Absorb is authorized for sale in CE Mark and certain independently regulated countries outside the United States.

Please check the regulatory status of the device in your geographic location prior to distribution.

Not to be reproduced, distributed or excerpted. ©2013 Abbott. All rights reserved AP2939100-OUS Rev. A 10/13 7

Do’s and Don’ts

• Properly and carefully size

the vessel

• Prep the lesion thoroughly

• Pay attention to expansion

limits

• Leave scaffolds under-

expanded

• Re-insert the device after

it has been removed from

the body

• Push against resistance during

delivery, or when passing

other catheters through a

deployed scaffold

DO DON’T

Absorb is authorized for sale in CE Mark and certain independently regulated countries outside the United States.

Please check the regulatory status of the device in your geographic location prior to distribution.

Not to be reproduced, distributed or excerpted. ©2013 Abbott. All rights reserved AP2939100-OUS Rev. A 10/13 8

Resorption M

n (

kD

a)

Months

Ma

ss

Lo

ss

(%

)

Months

Molecular Weight (Mn) and Mass Loss: Resorption by 36 Months

Images and data on file with Abbott Vascular. Histology images are porcine arteries.

1 month 12 months 18 months 24 months 30 months 36 months 42 months

Absorb is authorized for sale in CE Mark and certain independently regulated countries outside the United States.

Please check the regulatory status of the device in your geographic location prior to distribution.

Not to be reproduced, distributed or excerpted. ©2013 Abbott. All rights reserved AP2939100-OUS Rev. A 10/13 9

1 month 12 months 18 months 24 months 30 months 36 months 42 months 6 months 3 months

Remodeling R

efe

ren

ce V

ess

el L

um

en

Are

a (

mm

2)

Model Inherent Arterial Growth

Lu

me

n A

rea

(m

m2)

Lumen Gain with Absorb BVS

Results obtained by IVUS. Data presented as Mean ± SD. Data and images on file with Abbott Vascular.

Benign Lumen Gain via Arterial Growth

Absorb is authorized for sale in CE Mark and certain independently regulated countries outside the United States.

Please check the regulatory status of the device in your geographic location prior to distribution.

Not to be reproduced, distributed or excerpted. ©2013 Abbott. All rights reserved AP2939100-OUS Rev. A 10/13 10

Post-Dilatation Kissing Balloon

• Simultaneous balloon inflations will cause mechanical disruption of

proximal scaffold rings, if kissing balloons are over-sized

• Mechanical Disruption of Ring = impact radial strength

• Mechanical Disruption of Link = no impact on radial strength

Example:

D1 = 3.32 mm

D2 = 2.81 mm

R = 4.36 mm

Main Branch Balloon

Side Branch Balloon

Kissing Balloons

SEVERE OVER-EXPANSION

Morino, Y., et al. Circ J. 2008; 72: 886-892.

DO NOT PERFORM THIS TECHNIQUE!

*Kissing balloon technique is considered off-label and techniques referenced must be indicated by physician only.

Absorb is authorized for sale in CE Mark and certain independently regulated countries outside the United States.

Please check the regulatory status of the device in your geographic location prior to distribution.

Not to be reproduced, distributed or excerpted. ©2013 Abbott. All rights reserved AP2939100-OUS Rev. A 10/13 11

Various Approaches to Estimate Diameters

Perimeter Limits ( p*D)

3.5 = 11 mm

Example:

D1 = 3.32 mm

D2 = 2.81 mm

Finet Dm = 4.156 mm

Perimeter = 13 mm

From Stankovic, G, Treatment of Bifurcation Lesions: General Perspective, EBC 2011, Paris, FR

The Absorb IFU precautions the operator against scaffolding across side branches ≥ 2.0 mm in diameter.

Absorb is authorized for sale in CE Mark and certain independently regulated countries outside the United States.

Please check the regulatory status of the device in your geographic location prior to distribution.

Not to be reproduced, distributed or excerpted. ©2013 Abbott. All rights reserved AP2939100-OUS Rev. A 10/13 12

Protecting a Side Branch

• Protecting a side branch with a wire while deploying a scaffold in

the main branch

• Side Branch Protection

– HI-TORQUE BALANCE MIDDLEWEIGHT wires in main branch and side branch

– 3.0 x 18 mm BVS in main branch deployed at 16 atm for 30 seconds

Impressions on the coating denoting the location of the wire

but no structural or signifcant coating integrity defects.

Photos taken by and on file with Abbott Vascular.

The Absorb IFU precautions the operator against scaffolding across side branches ≥ 2.0 mm in diameter.

Absorb is authorized for sale in CE Mark and certain independently regulated countries outside the United States.

Please check the regulatory status of the device in your geographic location prior to distribution.

Not to be reproduced, distributed or excerpted. ©2013 Abbott. All rights reserved AP2939100-OUS Rev. A 10/13 13

Side Branch Dilatation ONLY

Malapposition

2.5 mm balloon in side branch taken to nominal pressure

Photos taken by and on file with Abbott Vascular.

The Absorb IFU precautions the operator against scaffolding across side branches ≥ 2.0 mm in diameter..

Absorb is authorized for sale in CE Mark and certain independently regulated countries outside the United States.

Please check the regulatory status of the device in your geographic location prior to distribution.

Not to be reproduced, distributed or excerpted. ©2013 Abbott. All rights reserved AP2939100-OUS Rev. A 10/13 14

SB Dilatation with Sequential MB Post-Dilatation

No Malapposition

2.5 mm balloon in side branch taken to nominal pressure, deflated, then 3.0 x 18 mm delivery system balloon taken to 16 atm for post-dilatation

Photos taken by and on file with Abbott Vascular.

The Absorb IFU precautions the operator against scaffolding across side branches ≥ 2.0 mm in diameter..

Absorb is authorized for sale in CE Mark and certain independently regulated countries outside the United States.

Please check the regulatory status of the device in your geographic location prior to distribution.

Not to be reproduced, distributed or excerpted. ©2013 Abbott. All rights reserved AP2939100-OUS Rev. A 10/13 15

Side Branch Dilatation ONLY

= Mechanical Disruption of Link

Photos taken by and on file with Abbott Vascular.

The Absorb IFU precautions the operator against scaffolding across side branches ≥ 2.0 mm in diameter.

Absorb is authorized for sale in CE Mark and certain independently regulated countries outside the United States.

Please check the regulatory status of the device in your geographic location prior to distribution.

Not to be reproduced, distributed or excerpted. ©2013 Abbott. All rights reserved AP2939100-OUS Rev. A 10/13 16

Summary – the Do’s and Don’ts

• Properly and carefully size

the vessel

• Prep the lesion thoroughly

• Pay attention to expansion

limits

• Never use the kissing

balloon technique*

• Leave scaffolds under-

expanded

• Re-insert the device after

it has been removed from

the body

• Push against resistance

during delivery, or when

passing other catheters

through a deployed scaffold

*Kissing balloon technique is considered off-label and techniques referenced must be indicated by physician only.

DO DON’T

Abbott Vascular International BVBA, Park Lane, Culliganlaan 2B, B-1831 Diegem, Belgium, Tel:

+32 2 714 14 11.

Absorb and HI-TORQUE BALANCE MIDDLEWEIGHT are trademarks of the Abbott Group of

Companies. Absorb is authorized for sale in CE Mark and certain independently regulated

countries outside of the U.S.. Please check

the regulatory status of the device in your geographic location prior to distribution. Not to be

reproduced, distributed or excerpted.

For more information, visit our web site at www.abbottvascular.com.

©2013 Abbott. All rights reserved.

AP2939100-OUS Rev A 10/13