abbott vascular bifurcation program€¦ · ap2932524 rev a june 2010 1 xience sba is currently a...

AP2932524 Rev A June 2010

XIENCE SBA is currently a pipeline product at Abbott Vascular. Not available for sale. Information contained herein for presentation outside of the U.S. and outside Japan. Not to be reproduced, distributed, or excerpted.

© 2010 Abbott Laboratories

Abbott Vascular Bifurcation Program XIENCE SBA

1AP2932524 Rev A June 2010



XIENCE SBA Continuing to Innovate Based on the Superiority1 of XIENCE V

Consistently Exploring the Next Generation DES

2006 2009 ---- --------

XIENCE SBA2 BVS2New Alloy

DES2

2. Pipeline products currently in development. Not available for sale.

1. Xience V has demonstrated statistical superiority against Taxus Express in the primary endpoints of SPIRIT IV, SPIRIT III, and SPIRIT II in target lesion failure, in-segment late loss, and in-stent late loss, respectively. Source: SPIRIT IV 1-Year results and data on file at Abbott Vascular.

Human Hai

r

PrésentateurCommentaires de présentationABT Analyst Presentation 3/24/07

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DRUG/ DOSE

POLYMER/ RELEASE RATE

STENT MATERIAL

STENT DELIVERY SYSTEM (SDS)

STENT DESIGNPRODUCT

XIENCE V®

XIENCE PRIME

New Alloy DES *

Bioresorbable Vascular Scaffold * Polylactide

Fluorinated Copolymer

Cobalt Chromium

Polylactide ML VISION® NEW

ML VISION®ML VISION®

NEW

NEW

NEW

NEW

NEW

Everolimus

*Note: Pipeline products. Currently in development at Abbott Vascular. Not available for sale. Pictures on file at Abbott Vascular.

XIENCE SBA Building Upon Proven “Ingredients”

XIENCE SBA * NEWNEW

FluorinatedCopolymer

CobaltChromium

PrésentateurCommentaires de présentationKey Messages:Our future products will be built on the leadership established by XIENCE V®In today’s regulatory environment, companies need to be more thoughtful than ever when developing productsYou shouldn’t see a company flitting from stent to stent (read: BSX) or from polymer to polymer (read: MDT)This slide illustrates how we’re improving our products:We continue our fundamental tenets of Multi-Link development (e.g., thinner struts are better); we have found that our everolimus drug dose and release profile are effective, so we are not changing themAlthough the stent design says it’s new, it is actually an improvement based upon the Multi-Link designThe delivery system is an area that deserves continual improvementOur bioresorbable device holds a lot of promise for a stent that will not remain in the vessel foreverIt will leverage everolimus and the VISION delivery system, but the stent and the drug coating are made from polylactic acid, a fully bioresorbable polymer that goes through the Krebs Cycle and results in CO2 and H2O, which are absorbed mostly into the tissue

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XIENCE V – Superiority in Clinical Endpoints in SPIRIT IV, the largest RCT to have presented primary endpoint data

SOURCE: Gregg Stone, SPIRIT IV 1 year, TCT-09. Data from Kaplan Meier curves. TLF Components = Target Vessel MI, ID-TLR and Cardiac Death.

• XIENCE V had a 39% reduction in TLF compared to TAXUS, driven by reductions in target vessel MI and ischemia-driven TLR.

XIENCE V has demonstrated statistical superiority against TAXUS Express in the primary endpoints of SPIRIT IV, SPIRIT III, and SPIRIT II in target lesion failure, in- segment late loss, and in-stent late loss, respectively. Source: SPIRIT IV 1-Year Results and data on file at Abbott Vascular.

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XIENCE V: Significant Reductions in Stent Thrombosis

• XIENCE V had a 74% reduction in Definite/Probable Stent Thrombosis compared to TAXUS in both SPIRIT IV and COMPARE

“The simultaneous reduction of stent thrombosis, MI, and TLR with XIENCE V demonstrates that ‘low late loss’ may be achieved with a DES without sacrificing safety.” – Dr. Gregg Stone

SOURCE: Gregg Stone, SPIRIT IV 1 year, TCT-09 SOURCE: P. Smits, COMPARE 1 year, TCT-09.

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XIENCE V – Low Event Rates Continue Long Term

SOURCE: David Cox, SPIRIT III 3-Year Results, TCT-09.MACE Components = cardiac death, MI, or ischemia-driven TLR.

• Difference in MACE between XIENCE V and TAXUS continues to separate out to 3 years• XIENCE V Definite/Probable Stent Thrombosis from 1 to 3 years is a low 0.3%

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XIENCE V: Stent Thrombosis Rates Consistently Below 1% in Multiple All Comers Trials

XIENCE V ARC Def/Prob Stent Thrombosis Rates at 1 Year in All Comer Trials

Source: Eberhard Grube, SPIRIT V, 1-Year Results, PCR 2009.Source: Kedhi et al, COMPARE, Lancet 2010; 375: 174-6. Source: Patrick Serruys, RESOLUTE AC 1-Year Results, PCR 2010.Source: James Hermiller, XIENCE V USA 1-Year Results, PCR 2010.

Results from clinical trials are not directly comparable. Information provided for educational purposes only.

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XIENCE V in Bifurcations Clinical Data from SPIRIT V Real World Study

• 19% of SPIRIT V patient population presented with bifurcations• Low observed rates of Target Lesion Failure and Stent Thrombosis

• No statistical difference compared to patients without bifurcations

Results at 1-Year*

Hierarchical

Patients with Bifurcations**

N=502

Patients without

Bifurcations

N=2098

P-Value

Composite of Cardiac Death, MI not clearly attributed to a non- target vessel and TLR (%) (Target Lesion Failure / TLF)

6.6 4.7 0.090

*CEC adjudicated according to Academic Research Consortium (ARC) Definitions

** Patients with at least one bifurcation lesion treatment

Stent Thrombosis Rates*(Definite and Probable)

Patients with Bifurcations**

N=508

Patients without Bifurcations

N=2155P-Value

Acute 0.0 0.2 1.000Subacute 0.4 0.2 0.625Late 0.0 0.3 0.603

Cumulative to 1 year 0.4 0.7 0.552

*CEC adjudicated according to Academic Research Consortium (ARC) Definitions

** Patients with at least one bifurcation lesion treatment

89% of patients on Clopidogrel or Ticlopidine at one year97% of patients on ASA at one year

Source: V. Dzavik, Safety and Efficacy of the XIENCE V Everolimus Eluting Stent in Patients with Bifurcation Lesions: A Subgroup Analysis from the SPIRIT V Single Arm Study, CRT 2010.

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XIENCE SBA Design Objective: Overcome Limitations of Current Workhorse Bifurcation Techniques

Elegant, intuitive designMake side branch access ‘easy’

• Maintain wire access to the side branch• Reduce or eliminate wire wrap

Ease of Use

Procedural Success

Long Term Safety and

Efficacy

Minimize variation in procedure times Increase the frequency of successful outcomesPreserve the side branch

Same long term safety and efficacy equivalent to best-in-class workhorse DES

Objectives:

PrésentateurCommentaires de présentationStart 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.

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Single Tip Delivery

MULTI-LINK® FRONTIER™ Deployment Concept

XIENCE Coating Technology

MULTI-LINK VISION®

CoCr Design

Flexible MULTI-LINK

VISION® Catheter

XIENCE SBAXIENCE SBA Dual Balloon Inflation

XIENCE V Coating and Materials Redesigned Delivery System Based on MULTI-LINK® FRONTIER™ Concept

XIENCE SBA Program Builds on XIENCE Coating Technology and MULTI-LINK® FRONTIER™ Concept

PrésentateurCommentaires de présentationIn 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.

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XIENCE SBA Design Components

• Side branch access

• Single tip delivery

• Ease of use

Redesigned MULTI-LINK® FRONTIER™

Delivery System

Cobalt Chromium Stent Material

FluorinatedCopolymer Everolimus

• Thin 0.0032” struts, same as XIENCE V

• Radiopaque

• Controlled drug release

• Biocompatible fluorinated copolymer

• Excellent mechanical integrity

• Similar dose and release rate to XIENCE V

11AP2932524 Rev A June 2010



XIENCE SBA Stent Design

Distal ProximalSide Branch Portal

Main Branch ID Side Branch Access ID Stent Length

2.5 mm 2.0 mm 18 mm

3.0 mm 2.5 mm 18 mm

12AP2932524 Rev A June 2010



XIENCE SBA Delivery System Based Upon MULTI-LINK® FRONTIER™ Concept

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

Dual lumen tip

Joining mandrel inserted through OTW inner member

Main Branch (RX)

Side Branch (OTW)

13AP2932524 Rev A June 2010



1. Advance system into the main branch, over conventional RX wire

1. Advance system into the main branch, over conventional RX wire

XIENCE SBA Deployment Sequence

2. Retract joining mandrel to release the OTW side-branch tip. Insert exchange length guide 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

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

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

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XIENCE SBA Deployment Sequence

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XIENCE SBA – Deployment In Vivo Ovine Animal Model

1. XIENCE SBA delivered to bifurcation via conventional RX wire

Tests performed by and data on file at Abbott Vascular.

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XIENCE SBA – Deployment In Vivo Ovine Animal Model2. Joining mandrel retracted and wired into side branch.

4. XIENCE SBA advanced to carina.


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XIENCE SBA – Deployment In Vivo Ovine Animal Model4. XIENCE SBA stent deployed via single inflation kissing balloons.

5. Final result after XIENCE SBA delivery system retracted.


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XIENCE SBA Ovine Study Acute Performance vs. Provisional T

0

2

4

6

8

10

12

Procedure Time

min

utes

ML VISION

XIENCE SBA

37% Reduction

p = 0.013

N = 6 N = 6

XIENCE SBA led to a statistically significant reduction in total procedure time


19AP2932524 Rev A June 2010




0

1

2

3

4

5

6

7

Fluoroscopy Time

min

utes

ML VISION

XIENCE SBA

44% Reduction

p = 0.12

N = 6 N = 6

XIENCE SBA requires less fluoroscopy time compared to provisional T stenting


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0

10

20

30

40

50

60

70

80

Contrast Volume

mill

ilite

rs

ML VISION

XIENCE SBA

51% Reduction

p = 0.092

N = 6 N = 6

XIENCE SBA requires half the contrast volume compared to provisional T


21AP2932524 Rev A June 2010



XIENCE SBA Porcine Study Full Deployment with Side Branch Preservation

• XIENCE SBA allows for easy crossing of additional stent into side branch

• Portal structure is well apposed to the side branch ostium

• Max post-dilatation diameters• 3.75 mm main branch• 3.0 mm side branch

Photo taken by and data on file at Abbott Vascular.

22AP2932524 Rev A June 2010



XIENCE SBA In Vitro Deployment with Side Branch Stent

Minimal protrusion of side branch stent into main branchXIENCE SBA provides side branch

ostial coverage where it is required

SOURCE: Rizik, et al. Evaluation of a Bifurcation Drug-Eluting Stent System versus Provisional T-Stenting in a Perfused Synthetic Coronary Artery Model, Journal of Interventional Cardiology, Vol 22, No. 6, 2009 537-546.

AP2932524 Rev A June 2010



Diapositive numéro 1XIENCE SBA�Continuing to Innovate Based on the Superiority1 of XIENCE VXIENCE SBA�Building Upon Proven “Ingredients”Diapositive numéro 4XIENCE V: Significant Reductions in Stent ThrombosisXIENCE V – Low Event Rates Continue Long TermXIENCE V: Stent Thrombosis Rates Consistently �Below 1% in Multiple All Comers TrialsXIENCE V in Bifurcations�Clinical Data from SPIRIT V Real World StudyXIENCE SBA Design Objective: Overcome Limitations of Current Workhorse Bifurcation TechniquesXIENCE SBA Program Builds on XIENCE Coating Technology and MULTI-LINK® FRONTIER™ ConceptXIENCE SBA Design ComponentsXIENCE SBA �Stent DesignXIENCE SBA Delivery System�Based Upon MULTI-LINK® FRONTIER™ ConceptXIENCE SBA�Deployment SequenceXIENCE SBA�Deployment SequenceXIENCE SBA – Deployment In Vivo �Ovine Animal ModelXIENCE SBA – Deployment In Vivo �Ovine Animal ModelDiapositive numéro 18XIENCE SBA Ovine Study�Acute Performance vs. Provisional TXIENCE SBA Ovine Study�Acute Performance vs. Provisional TXIENCE SBA Ovine Study�Acute Performance vs. Provisional TXIENCE SBA Porcine Study�Full Deployment with Side Branch PreservationXIENCE SBA �In Vitro Deployment with Side Branch StentDiapositive numéro 24

abbott vascular bifurcation program€¦ · ap2932524 rev a june 2010 1 xience sba is currently a...

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