SYNERGY - Genodynamic · INTRODUCING THE SYNERGY TM Everolimus-Eluting Stent System featuring the...
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Transcript of SYNERGY - Genodynamic · INTRODUCING THE SYNERGY TM Everolimus-Eluting Stent System featuring the...
B I O a B S O R B a B L E R E D E F I N E D
SYNERGYTM
Everolimus-Eluting Platinum Chromium Coronary Stent System
INTRODUCING THE
SYNERGYTM Everolimus-Eluting Stent System featuring the innovative SynchronyTM Bioabsorbable Coating
The result:
Freedom from Long-Term Polymer Exposure, Optimal Healing and Easier, More Confident Deliverability.*
The SYNERGY Stent System redefines bioabsorbable
drug-eluting stent technology by delivering the safety and
efficacy of Everolimus with synchronized drug release
and polymer absorption over an optimal 3-month period.*
It does this on an ultra-thin Platinum Chromium platform
and high-performance stent delivery system.
*Boston Scientific Data on File
Freedom from Long-Term Polymer Exposure
Drug elution is complete at 3 months*
Polymer gone shortly after drug elution is complete*
anti-Inflammatory benefit of Everolimus remains in tissue during entire time of polymer absorption*
Other bioabsorbable polymers take 3 to 10 times longer to absorb, causing long gaps between full drug elution and full polymer absorption
1 PLGA = Polylactic Glycolic Acid2 Garg, S, J Am Coll Cardiol. 2010;56(10s1):S43-S78. doi:10.1016 3 World J Cardiol 2011 March 26; 3(3): 84-924 Presented by Stephen Windecker, MD, TCT2012* Boston Scientific Data on File
The SYNERGY stent‘s Synchrony™ Bioabsorbable Coating is made up of a hydrophilic
PLGA1 polymer and Everolimus drug which absorb and elute in a synchronized manner
– making it the only DES with 3-month drug release and polymer absorption.
POlymER IS GONE WhEN NO lONGER NEEDED
Time (months)
Mas
s Re
mai
ning
(%)
100 -
80 -
60 -
40 -
20 -
0 -0 3 6 9 12 18
- - - - - -
PLGAEverolimus
Time (months)
Mas
s Re
mai
ning
(%)
100 -
80 -
60 -
40 -
20 -
0 -0 3 6 9
- - - -
PLABA9
Time (months)
Mas
s Re
mai
ning
(%)
100 -
80 -
60 -
40 -
20 -
0 -0 3 6 9
- - - -
PLLASirolimus
Time (months)
Mas
s Re
mai
ning
(%)
100 -
80 -
60 -
40 -
20 -
0 -0 3 6 9
- - - -
PLLAEverolimus
BioMatrix Flex™2 + Nobori™3 Orsiro™4 Absorb™ BVS3 Polymer Coating: PLAAbsorption Time: > 9 months
Polymer Coating: PLLAAbsorption Time: > 12 months
Polymer Scaffold: PLLAPolymer Coating: PDLLAAbsorption Time: > 2 years
Bioabsorbable Polymer-Coated Stents Bioabsorbable Scaffold
B i o a B s o r B a B l e R E D E F I N E D
SYNERGY™ + Synchrony™
Optimal HealingFUNCTIONAl ENDOThElIAlIzATION AND PASSIvE vASCUlAR RESPONSE
Three design features function in synergy to allow for healthy endothelialization
and passive vascular response comparable to a Platinum Chromium (PtCr) OMEGATM
Bare Metal Stent (BMS) at 3 months.1
1 Presented by Gregory J. Wilson, MD. ACC 20112 Presented by Ian T. Meredith, MBBS, PhD, EuroPCR 20133 From SYNERGY DFU. Indications, contraindications, warnings, precautions and instructions for use can be found in the product labeling supplied with each device.* Boston Scientific Data on File
OMEGA™ Bare Metal
Stent
SYNERGY™ Stent
B i o a B s o r B a B l e R E D E F I N E D
23
1
30 days 90 days
1. Everolimus drug: similar drug dose and release kinetics as PROMUS Element™ Stent Safety and efficacy shown in the EvOlvE trial 2-year outcomes2:
•1.1 %TLR •0 %StentThrombosis •0.10mm6-monthIn-StentLateLoss
2. Ultra-thin Synchrony™ Bioabsorbable Coating Only on abluminal side, bare PtCr surface in the lumen 4 μm thin low polymer load
3. Thin-strut, 74μm PtCr platform highly flexible and conformable high resistance to fracture Exceptional radial strength for good strut apposition*
In preclinical studies Complete endothelialization by 30 days Similar vascular response to SyNERGy™
Stent and OmEGA BmS at 3 months*
3-month DaPT Labeling3
In selected patients, it may be reasonable to interrupt or discontinue P2y12 inhibitor therapy after 3 months.
Easier, More Confident DeliverabilityImPROvED PROCEDURAl PERFORmANCE
The SYNERGY™ Stent offers a new PtCr architecture with thinner struts to improve
endothelialization, deliverability, and conformability while maintaining the strength,
visibility, flexibility and fracture resistance of the current Element™ design.*
Rounder, thinner PtCr struts1
reduce crossing profiles while maintaining strength and radiopacity
additional connectors on the end-most proximal and distal segments increase strength while maintaining flexibility, conformability, and fracture resistance
New stent delivery system with laser-cut hypotube for improved pushability and trackability*
Most extensive size matrixAvailable in 48 monorail sizes
Hypotube with variable pitch Laser-cuts
Laser-cut section
End Tab
1 Synergy Stent strut thickness 2.25 - 3.50 mm: 74 μm, 4.00 mm: 81 μm* Boston Scientific Data on File
PROMUS Element™81 μm
SYNERGY™74 μm
All cited trademarks are the property of their respective owners. CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. Information for the use only in countries with applicable health authority product registrations.
Information contained herein is for distribution outside the U.S. only. Illustrations for information purposes – not indicative of actual size or clinical outcome.
IC-147814-AB May 2013 Printed in Germany by medicalvision.
www.bostonscientific-international.com
© 2013 Boston Scientific Corporationor its affiliates. All rights reserved.DINCAR2613EB
ømm
Stent Length (mm)
8 12 16 20 24 28 32 38
2.25 H7493919808220 H7493919812220 H7493919816220 H7493919820220 H7493919824220 H7493919828220 H7493919832220 H7493919838220
2.50 H7493919808250 H7493919812250 H7493919816250 H7493919820250 H7493919824250 H7493919828250 H7493919832250 H7493919838250
2.75 H7493919808270 H7493919812270 H7493919816270 H7493919820270 H7493919824270 H7493919828270 H7493919832270 H7493919838270
3.00 H7493919808300 H7493919812300 H7493919816300 H7493919820300 H7493919824300 H7493919828300 H7493919832300 H7493919838300
3.50 H7493919808350 H7493919812350 H7493919816350 H7493919820350 H7493919824350 H7493919828350 H7493919832350 H7493919838350
4.00 H7493919808400 H7493919812400 H7493919816400 H7493919820400 H7493919824400 H7493919828400 H7493919832400 H7493919838400
SYNERGYTM Everolimus–Eluting Coronary Stent System – Product Ordering Information
SYNERGY Stent Monorail® | Available in 48 sizes
SYNERGYTM Stent Delivery System
Dual-Layer PEBAX® Balloon Laser-Cut Hypotube
Platinum Iridium Markerbands PTFE Coated Hypotube
0.018 inch (0.46 mm) Tip Profile