Brave Decisions with premier stent

Yasser Ahmed Sadek, MD

NHI

CLINICAL HISTORY

• Male pt 46 ys old.

• Diabetic(IDDM) for more than 20 ys,ex-smoker and hyperlipidemic.

• He complained of exertional chest pain with effort 2 months ago with (CCS II).

• He started medical treatment and 2 weeks later he developed severe chest pain and diagnosed as NSTEMI.

LAB

• HB 13.2 gm/dl

• Urea 48 , cretinine 1.4mg/dl

• Troponin: 0.2 ng/dl

• ECG: ST segment depression at anterolateral leads

• ECHO:SWMA at the entire apex and inferolateral wall with preserved LV global systolic function

1st Coronary angiography

CA continued

Trial of PCI

Multiple Balloon Inflations(8 balloons)and failed to cross two different types of the stents

Tight proximal focal calcific lesion resistant to high pressure balloon inflation

Follow up

• The patient chest pain related procedure controlled on maximal medical treatment.

• The patient refused surgery and he insisted to do PCI again after recurrence of exertional chest pain.

• What we need……….

Equipment's needed

• High pressure balloon.

• Cutting balloon.

• Rotablator.

• IVUS.

• the exceptional pushability, trackability and flexibility stents.

EPU guiding catheter3.5/6f via transradialapproach

SION 0.014 guiding wire

The guiding wire changed by rota wire via microcatheter then Rotablator 1.5 burr

10 min to cross by Rota then Quantum balloon 2.75x20mm

Quantum NC 3.25x20mm and 3.5x20mm also failed to fully inflated at the same lesion

IVUS Catheter

IVUS

Finally Flextome cutting balloon 3.25x15mm fully inflated successfully

Premier stent 2.75x24mm distally overlapped by premier stent 2.75x32mm

Wiring of 1st OM by Sion wire

Body wire by PT(LS)wire and premier stent 2.75x38mm after the predilation

The ostial LAD showed significant lesion!!!!!!!

IVUS for LAD

Stenting ostial LAD by premier stent 3.5X12mm and postdilation by NC balloon 4x20mm

Just ostial

Final angio

Final angio, continued

• What is the Rotablator System?

• Rotational Atherectomy System• Diamond-tipped burr designed to preferentially ablate calcium and fibrous

plaque

• System includes both capital equipment and disposable components

• Capital Equipment• Console

• Foot Pedal

• Air Tank

• Disposables• Wires

• Advancer

• Burr

RotablatorTM

Rotational Atherectomy System

Prior to use, please see the complete ‘Directions For Use’ for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events and Operator’s Instructions.

Clinical Application

• Why use Rotational Atherectomy?

• Calcium is out there.

• The prevalence of severe calcium, defined as superficial in nature with greater than 180° arc, is estimated to present itself in 12% of cases using angiographic imaging. When IVUS guidance is used, it’s seen in approximately 26% of cases.1

• Calcium can preclude optimal stenting.

• Asymmetrical stent expansion occurs in up to 50% of cases where calcium is not treated before stent deployment.2

• With DES, rotational atherectomy is an important tool for calcified lesions.

• Lesion preparation with compliance change for a calcified lesion can substantially facilitate stent delivery and symmetrical stent expansion for more homogeneous drug delivery.3

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1. Mintz et al. Patterns of Calcification in Coronary Artery Disease. Circulation April 1995, Volume 91, No 7

2. Moussa, Moses, Columbo et al. Coronary Stenting After Rotational Atherectomy in Calcified and Complex Lesions. Circulation 1997; 96:128-136

3. Iakovou, I. et. al. J Am Coll Cardiol 2005;46:1446-55

Prior to use, please see the complete ‘Directions For Use’ for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events and Operator’s Instructions.

• Porcine Model*

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RotablatorTM System result with minimal vessel injuryAngioplasty result with vessel injury

Intended PTCRA benefits• Minimize vessel wall stretch and elastic recoil • Eliminate vessel barotrauma• Produce a smooth lumen/channel• Facilitate stent delivery and expansion

Mechanism of Action

*Porcine model results may not necessarily be indicative of clinical performance.

Prior to use, please see the complete ‘Directions For Use’ for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events and Operator’s Instructions.

Key Procedural Steps

Important reminder on Burr movement

• The directions for use (DFU) for the RotablatorTM RotalinkTM Burr Catheters specify to always keep the burr advancing or retracting while it is rotating.

• Maintaining the burr in one location while it is rotating may lead to excessive tissue removal or damage to the Rotablator system.

• System damage could include wire damage or fracture.

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Illustration by Boston Scientific

Prior to use, please see the complete ‘Directions For Use’ for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events and Operator’s Instructions.

FlextomeTM Cutting BalloonTM Device in Complex Lesions

33*When treating lesions at a bifurcation, the Cutting Balloon Device can be used prior to placing a stent, but should not be taken through the side cell of a stent to treat theside branch of a lesion at a bifurcation.

*

FlextomeTM Cutting BalloonTM Device in Complex Lesions

In-Stent Restenosis Lesions - Avoid balloon slippage• Lesions with a high composition of neo-intimal hyperplasia which offer greater resistance to

dilatation and cause balloon slippage1,2

• The scoring mechanism of action of the Cutting BalloonTM device allows controlled dilatation while preventing balloon slippage3.

Ostial and Bifurcation* Lesions - Avoid Plaque shift• Challenging lesion subsets with a higher degree of recoil and potential of plaque shift effect

• The Cutting BalloonTM device successfully dilates while reducing elastic recoil4 and allowing more plaque compression with minimal plaque shift and less vessel stretching5,6,7

Fibrotic lesions - Change lesion compliance• Resistant lesions with a higher concentration of elastin and muscle fibers

• Cutting BalloonTM atherotomes gently score through fibrotic plaque providing a novel and simple strategy for coronary lesions resistant to conventional balloon dilatation15

34

The FlextomeTM Cutting BalloonTM device is a unique** and effective*** tool for the mechanical challenges of complex lesions that are often resistant to conventional

balloon angioplasty

*When treating lesions at a bifurcation, the Cutting Balloon Device can be used prior to placing a stent, but should not be taken through the side cell of a stent to treat the side branch of a lesion at a bifurcation.**As know to date on the market****Compared to Cutting Balloon Ultra²TMBench testing and cadaver testing conducted by Boston Scientific Corporation. N=3, 3.0mmx15mm balloons. Data on file. Bench test results may not necessarily be indicative of clinical performance.Please refer to Glossary for references

Flextome is better than Ultra 2

35

• 30% more Deliverable*

• 50% better Re-cross*

• Distal shaft PEBAX® - better tracking and flexibility

• Mid shaft nylon blend vs. braid -better flexibility

• Atherotome Flexpoints every 5 mm for more flexibility • Catheter shaft MaverickTM platform

• Rated Burst Pressure increased from 10ATM (1013kPa) to 12ATM (1216kPa)

• Non-compliant Nylon balloon material provides improved

flexibility, better re-wrap and puncture resistance*

Performance improvement*

Minor enhancements

Major enhancements

Based on bench testing

Differences from Cutting Balloon Ultra2™ Device

* Compared to Cutting Balloon Ultra²TMBench testing and cadaver testing conducted by Boston Scientific Corporation .N=3, 3.0mmx15mm balloons. Data on file. Bench test results may not necessarily be indicative of clinical performance.Pebax is a registered trademark of Arkema.

Deliverability

Flexibility

Cutting BalloonTM Device Clinical Benefits

• Precise dilatation

• Scoring the plaque by severing the elastic and fibrotic continuity of the vesselwall

• Lesion dilatation at lower pressures with less recoil compared to POBA

• Lumen gain through plaque compression instead of vessel wall expansion

• Successful vessel preparation prior to stent placement to avoid under expansion and malapposition

• Lower residual percent diameter stenosis with Cutting BalloonTM Device plus stent Versus POBA plus stent at post procedure and at 6 month follow-up.11

• High rate of delivery and deployment success

• Excellent acute outcomes when used as a primary therapy device

• No slippage on deployment – controlled vessel injury zone3

• Minimal plaque shift

• Low rates of acute complications, total dissections and severe dissection and perforations compared to POBA.

• Please refer to Glossary for references36

Technical ConsiderationsIndications/ Contraindications/Warnings

• Indications:

• The Flextome Cutting Balloon Device is indicated for use in patients with coronary vessel disease who are acceptable candidates for coronary artery bypass graft surgery, should it be urgently needed. In addition, the target lesion should possess the following characteristics:

• Discrete (<15 mm in length), or tubular (10 to 20 mm in length)

• Reference vessel diameter (RVD) of 2.00 mm - 4.00 mm

• Readily accessible to the device

• Light to moderate tortuosity of proximal vessel segment

• Nonangulated lesion segment (< 45°)

• Smooth angiographic contour

• Absence of angiographically visible thrombus

• Contraindications:• Use of the Cutting Balloon Device is contraindicated in situations where the Cutting Balloon Device would

be passed through the side cell of a previously placed stent as the deflated Cutting Balloon Device could become entangled in the stent.

• Coronary artery spasm in the absence of significant stenosis

• Warnings:• Exercise extreme care when treating a lesion distal to a stent. If the guidewire has passed through the

stent cell rather than down the axis of the stent, the deflated Cutting Balloon Device could become entangled in the stent. When treating lesions at a bifurcation, the Cutting Balloon Device can be used prior to placing a stent, but should not be taken through the side cell of a stent to treat the side branch of a lesion at a bifurcation

NEW Contraindication and Warning will also included in Cutting Balloon Ultra²TM DFU37

1. See Directions for Use for clinical outcomes – PLATINUM Clinical Trial Program.

2. Deliverability bench testing performed by Boston Scientific Corporation on 2.50 mm stents (n = 3). Data on file at Boston Scientific.

stent architecture for strength & flexibility

clinical outcomes1

deliverability2

Promus PREMIER™ Stent SystemCustomized for Premier Outcomes

CUSTOMIZED

OUTSTANDING

UNMATCHED

Procedural and Clinical ImpactAlloy and Design

Stent Platform

(BMS / DES)Alloy Deliverability

Radial

StrengthAxial Strength Radiopacity Conformability

Fracture

Resistance

Post-Dilatation

CapabilityRecoil

Velocity / Cypher

Platform

Stainless

Steel

(316L)

Vision / Xience

MultiLink / Xience

Xpedition™

Platform

Cobalt

Chromium

(L605)

Driver / Endeavor

Integrity / Resolute

Platform

Cobalt

Nickel

(MP35N®)

PREMIER

Platform

Platinum

Chromium

(PtCr)

Least Capable Capable Most Capable

1. Based on scientific properties of alloy and stent design. Data on file at Boston Scientific.

Promus PREMIER™ Stent System has several performance advantages1

Visibility ComparisonPlatinum has over 2x the density of Iron or Cobalt1

1. Data on file at Boston Scientific. Based on 2.50 mm stents. Copper phantom to simulate body mass. Photographs taken by Boston Scientific. Bench test results may not necessarily be indicative of clinical performance.

PtCr

Promus

PREMIER™

Stent

0.081 mm

(0.0032”)

CoCr

Xience V™

Stent

0.081 mm

(0.0032”)

CoCr

Xience

Xpedition™

Stent

0.081 mm

(0.0032”)

CoNi

Resolute

Integrity™

Stent

0.089 mm

(0.0035”)

PtCr

PROMUS

Element™

Stent

0.081 mm

(0.0032”)

CoCr

Orsiro™

Stent

0.060 mm

(0.0024”)

SS

Nobori™

Stent

0.112 mm

(0.0044”)

SS

BioMatrix

Flex™

Stent

0.112 mm

(0.0044”)

(Post Expansion - Percentage a stent diameter decreases after balloon deflation)

Exceptionally Low Recoil

Rec

oil (

%)

Less R

eco

il

Promus PREMIER™ Stent has up to 40% Less Recoil

than Cobalt Alloy Stents tested1

1. Bench testing performed by Boston Scientific Corporation. Data on file at Boston Scientific. All stents 2.50 mm; Promus PREMIER Stent n = 15, PROMUS Element Stent n = 15, Orsiro Stent n = 3, Xience Xpedition Stent n = 3,

Xience V Stent n = 10, Resolute Integrity Stent n = 3, Nobori Stent n = 3, BioMatrix Flex Stent n = 3.

Bench test results may not necessarily be indicative of clinical performance.

Exceptionally Low Acute Lumen Loss

Exceptionally Low Acute Lumen Loss

Exceptionally Low Acute Lumen Loss

Enhanced Design for Easier Deliverability

Pro

mu

s P

RE

MIE

R™

Ste

nt

Syste

m

Strong outer layer (72D)

Flexible inner layer (63D)

Features Advantages

Shorter Tip Improves tip flexibility

Red Tip Colorant Improves tip visibility when loading on a guidewire

PTFE Coating vs.

Nylon on Proximal

Shaft Hypotube

Reduced friction

Kink resistance

Proximal shaft profile and lubricity

Bi-Segment™ Inner

Lumen Catheter

Pushable proximal segment

Flexible distal segment

Dual-layer

PEBAX™ Balloon

Optimal compliance

Minimal balloon growth

1. Deliverability bench testing performed by Boston Scientific Corporation on 2.50 mm stents (n = 3). Data on file at Boston Scientific. Illustrations are not indicative of clinical performance.

Low Stent and Tip Profile

1.13 mm

(0.044”)

0.457 mm

(0.018”)

Xience Xpedition™

Stent System

1 mm

1.03 mm

(0.041”)

0.457 mm

(0.018”)

PROMUS Element™ Plus Stent System

1 mm

1.09 mm

(0.043”)

0.452 mm

(0.018”)

Xience V™

Stent System

1 mm

Crossing Profile Tip ProfileMarker Bands

1.02 mm

(0.040”)

0.455 mm

(0.018”)

Promus PREMIER™

Stent System

1 mm

1.10 mm

(0.043”)

0.500 mm

(0.020”)

Resolute Integrity™

Stent System

1 mm

1.17 mm

(0.046”)

0.465 mm

(0.018”)

Biomatrix Flex™

Stent System

1 mm

1. Data on file at Boston Scientific. All 2.50 mm stent systems, n = 3. Images by Boston Scientific. Cognex Test Method (crimped: distal, mid, proximal).

1.12 mm

(0.044”)

0.450 mm

(0.018”)

Nobori™

Stent System

1 mm

0.98 mm

(0.038”)

0.465 mm

(0.018”)

Orsiro™

Stent System

1 mm

PRESSURES 11

1115

15

1517

10

1013

9

912

8

811

16

1620

18

1827

17

1724

12

1213

13

1317

14

1420

6

608

2.50 – 2.75 mm

3.00 – 2.75 mm

ATM

kPa

2.25 – 2.75 mm

3.00 – 4.00 mm

4.00 mm

2.25 – 3.50 mm

2.25 – 2.50 mm

3.00 – 4.00 mm

Nominal and Rated Burst Pressures

Promus PREMIER™ Stent has exceptional compliance and low balloon growth

Promus PREMIER

Stent System

Xience V™

Stent System

Xience Xpedition™

Stent System

Resolute Integrity™

Stent System

2.25 – 2.75 mm

3.00 – 4.00 mm

2.25 – 3.00 mm

3.50 – 4.00 mm

2.25 – 3.00 mm

3.50 – 4.00 mm

Orsiro™

Stent System

Biomatrix Flex™

Stent System

Nobori™

Stent System

1. Promus PREMIER Stent System, Xience V Stent System, Xience Xpedition Stent System, Resolute Integrity Stent System, Orsiro Stent System, Biomatrix Flex Stent System and Nobori Stent System Directions for Use.

Total: 1.12 mm

0.53 mm

Total: 0.93 mm

0.44 mm

Total: 1.38 mm

0.55 mm

Inflated to 1114.575 kPa (11 ATM)

Total: 1.63 mm

0.65 mm

Inflated to 1823.25 kPa (18 ATM)

Minimal balloon overhang to help minimize vessel trauma or damage outside the stent

Low Balloon Overhang

Total: 1.14 mm

0.53 mm

Total: 1.01 mm

0.45 mm

Total: 1.24 mm

0.72 mm

Total: 1.43 mm

0.82 mm

Promus PREMIER™

Stent System

PROMUS Element™

Plus Stent System

Xience V™

Stent System

Xience Xpedition™

Stent System

Promus PREMIER

Stent System

PROMUS Element

Plus Stent System

Xience V

Stent System

Xience Xpedition

Stent System

Total: 1.32 mm

1.17 mm

Total: 1.48 mm

1.75 mmResolute Integrity™

Stent System

Resolute Integrity

Stent System

Total: 2.60 mm

1.47 mm

Total: 2.01 mm

0.79 mm

Total: 2.92 mm

1.69 mm

Total: 2.94 mm

1.31 mm

Biomatrix Flex™

Stent System

Nobori™

Stent System

Biomatrix Flex

Stent System

Nobori

Stent System

1. Data on file at Boston Scientific. Images taken by Boston Scientific. All 2.50 mm stent systems; n = 3. Bench test results may not necessarily be indicative of clinical performance..

Take Home Message

• Complex PCI needs all tools to be there.• The rotablator is a very helpful tool in heavily calcific

stentic arteries.• Oversized burr in diffuse calcium and too much pressure

can jam.• Cutting balloon providing a novel and simple strategy for

coronary lesions resistant to conventional balloon dilatation to prepare the vessel prior to stent placement.

• Premier stent has improved the tip flexibility ,the exceptional

pushability and also has outstanding trackability.

Thank You