1. Abbott Vascular Bifurcation Program

2. Charles A. Simonton, MD DISCLOSURES
Chief Medical Officer Abbott Vascular Santa Clara, CA

3. Long Term Safety and Efficacy
Design Objective: Bifurcation Device that Overcomes Limitations of Current Workhorse Bifurcation Techniques
Objectives:
Ease of Use
Has elegant, intuitive design
Makes side branch access ‘easy’
Reduces or eliminates wire wrap
Helps maintain wire access to the side branch
Procedural Success
Minimizes variation in procedure times
Increases the frequency of successful outcomes
Preserves the side branch
Start off by talking about the rationale behind our bifurcation development program. In speaking with a lot of physicians about how to treat bifurcation and their needs for a bifurcation-specific stent, several needs became apparent. Physicians wanted three things in an ideal bifurcation stent:
- Side branch preservation (maintaining wire access throughout the procedure, prevent SB jailing, simultaneous kissing)
- A predictable procedure (many WH techniques are operator dependant, technique dependant, we wanted to reduce this unpredictability. We also wanted to support a provisional T approach so that you don’t have to stent the SB unless you needed to). We also wanted to minimize procedure time as they tend to vary for bifurcations widely from hospital to hospital, MD to MD.
- Safety and Efficacy Finally, given the complexities of the design, we have to make sure first and foremost that this has good safety and efficacy. And perhaps offers a benefit than the current WH technique they use.
Long Term Safety and Efficacy
Has same long term safety and efficacy equivalent to best-in-class workhorse DES

4. Abbott Vascular Bifurcation Drug-Eluting Stent Program: Objectives
Redesigned MULTI-LINK® FRONTIER™ Delivery System
Cobalt Chromium Stent Material
Fluorinated Co-Polymer Coating
Everolimus
Side branch access
Single tip delivery
Ease of Use
Thin struts – same as XIENCE V
Radiopaque
Controlled drug release
Biocompatible fluorinated copolymer
Excellent mechanical integrity
Similar dose and release rate to XIENCE™ V
CAUTION: XIENCETM V is an investigational device. Limited by Federal (US) law to investigational use only.
ML Frontier™ is neither approved nor available in the US.

5. Redesigned Delivery System Based on MULTI-LINK® FRONTIER™ Concept
Bifurcation DES Program Builds on XIENCE™ Coating Technology and MULTI-LINK® FRONTIER™ Concept
XIENCE™ V Coating and Materials
Redesigned Delivery System Based on MULTI-LINK® FRONTIER™ Concept
XIENCE™
Coating Technology
Single Tip Delivery
Abbott Bifurcation DES
Dual Balloon Inflation
MULTI-LINK VISION®
CoCr Design
In designing a DES for bifurcations, we are building on the proven Frontier platform. This stainless steel stent is uniquely designed to allow for straightforward provisional T stenting and maintaining side branch access throughout the procedure. The stent is delivered over an RX catheter with the two tips joined together. After crossing the main branch lesion, the wire joining the tips is removed and the side branch is wired. The main branch and side branch balloons inflate simultaneously. We are coupling this desing with 6th generation stent technology, based on the Multi Link Vision platform. The new product will be a Cobalt Chromium stent mounted on a modified Vision delivery system and incorporates the Xience V drug formulation coating.
MULTI-LINK® FRONTIER™ Deployment Concept
Flexible MULTI-LINK VISION® Catheter
CAUTION: XIENCETM V is an investigational device. Limited by Federal (US) law to investigational use only.
ML Frontier™ is neither approved nor available in the US.

6. Abbott Vascular Bifurcation Stent Design
Distal
Side Branch Portal
Proximal
MCUSA: 1.9 mm2

7. Abbott Vascular Bifurcation Stent - Sizes
Main Branch Stent ID
Side branch Stent access ID
Stent Length
2.5 mm
2.0 mm
18 mm
3.0 mm

8. Based Upon MULTI-LINK® FRONTIER™ Concept
Main Branch (RX)
Dual lumen tip
Side Branch (OTW)
Joining mandrel inserted through OTW inner member
Design Features
Objectives
Single Tip Delivery
Ease of use
Avoid wire wrap
7F guide catheter compatible
Two Kissing Balloons
Deploy stent quickly
Minimize plaque shift
Side-Branch Portal
Provides ostial scaffolding
Enable side branch preservation
ML Frontier™ is neither approved nor available in the US.

9. Deployment Sequence
1. Advance system into the main branch, over conventional RX wire
2. Retract joining mandrel to release the OTW side-branch tip. Insert exchange length guide wire
3. Position guide wire in the side branch and advance system to the carina
4. With a single inflation device, stent is deployed with a single simultaneous inflation
Following deflation, the delivery system is retracted, preserving access to both branches
Source: John Ormiston, 2007
ML Frontier™ is neither approved nor available in the US.

10. Photos taken by and on file at Abbott Vascular.
Acute Placement of 3.0 x 12 mm Abbott Bifurcation DES in Porcine Coronary Vasculature
Photos taken by and on file at Abbott Vascular.

11. Porcine Study: Full Deployment with Side-Branch Preservation
On file at Abbott Vascular.

12. Bench Test with Side Branch Stent Placed
Courtesy, David Rizik MD

13. GLP Studies: PK Results – Drug Released
The analysis for this study is still ongoing. The available data for Pathfinder – up to 60 days – are comparable to the historical XIENCE™ V data up to this point. ™
Tests performed by and data on file at Abbott Vascular
CAUTION: XIENCETM V is an investigational device. Limited by Federal (US) law to investigational use only.

14. GLP Studies: PK Results – Tissue Concentration
Tests performed by and data on file at Abbott Vascular ™
On the same note, the arterial tissue concentration is similar in Pathfinder and XIENCE as well – the graph shows that data for Pathfinder up to 28 day which is what we have at this point.
CAUTION: XIENCETM V is an investigational device. Limited by Federal (US) law to investigational use only.

15. 28 Day Pre-Clinical Results – Fibrin and Inflammation
Fibrin Score (0-3)
Inflammation Score (0-4) ™ ™
n = 18
n = 11
n = 10
n = 18
n = 11
n = 10
Similar Drug Effect with Abbott Bifurcation DES and XIENCE™ V
Minimal Inflammation observed with Abbott Bifurcation DES
Tests performed by and data on file at Abbott Vascular.
CAUTION: XIENCETM V is an investigational device. Limited by Federal (US) law to investigational use only.

16. 28 Day Pre-Clinical Results – Percent Area Stenosis™
n = 18
n = 11
n = 10
% Area Stenosis of Abbott Bifurcation DES Comparable to XIENCE™ V and Is Overall Low (mean 20%)
Tests performed by and data on file at Abbott Vascular.
CAUTION: XIENCETM V is an investigational device. Limited by Federal (US) law to investigational use only.

17. Abbott Vascular Bifurcation DES (longitudinal section)
28-Day Porcine Model
Abbott Vascular Bifurcation DES
Proximal
(x-section)
Mid Stent Placement
(longitudinal section)
Distal
(x-section)
Photos on file at Abbott Vascular.

18. 28 Day Pre-Clinical Results – Representative Images
V. Giessen Elastic 2x
H&E 10x
XIENCE™ V
Abbott Bifurcation DES
In both stents all stent struts are incorporated in a thin SMC rich neointimal with near complete luminal endothelial coverage. Comparable drug effect is visible through the presence of mild to moderate para-strut fibrin as expected at 28-days
Thin, smooth muscle cell rich neointima
Photos taken by and on file at Abbott Vascular.
CAUTION: XIENCETM V is an investigational device. Limited by Federal (US) law to investigational use only.

19. 28 Day Pre-Clinical Results – SEM of Porcine Model
Complete luminal coverage
with Endothelial Cells
Photos taken by and on file at Abbott Vascular

20. GLP Summary
In animal models, Abbott Bifurcation DES demonstrated equivalent safety results to XIENCE™ V:
Drug released and tissue concentration equivalent to XIENCE™ V ( % of everolimus released at 28 days)
Neointimal composition comparable to XIENCE™ V
Near complete to complete luminal endothelialization
Equivalent vascular response and pharmacokinetics
CAUTION: XIENCETM V is an investigational device. Limited by Federal (US) law to investigational use only.