Stent SYNERGY

Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Information for the use only in countries with applicable health authority product registrations.
SYNERGY and Promus PREMIER are unregistered or registered trademarks of Boston Scientific or its affiliates. All other trademarks are property of their respective owners..
This material is not for use in the U.S., France or Japan.
IC-215308-AG OCT2015 1 of 84
Stent SYNERGY™
PEWNE GOJENIE
Konstrukcja – pokrycie abluminalne1
Szybkie gojenie2
Skrócona obecność polimeru3
Thin Abluminal
Coating
1. Eppihimer M, PhD. Impact of Polymer Type and Location on Stent Thrombogenicity and Endothelial Cell Coverage. EuroPCR 2013.
2. Image provided by Jose M. De la Torre Hernandez, MD, PhD.
3. Chen YL, PhD, Foss A, PhD, Eppihimer M, PhD, et al. Characterization of In Vivo Poly (DL-lactic-co-glycolic acid) Bioabsorption from a Drug-Eluting Stent. EuroPCR 2012.
This material is not for use in the U.S., France or Japan.
IC-215303-AF MAY2015.
Stent SYNERGY™
This material is not for use in the U.S., France or Japan.
IC-215303-AF MAY2015.
Stent SYNERGY™
DES SYNERGY™
zapewnia gojenie
w ciągu trzech
miesięcy3
• Możliwość przeprężenia1,
siła radialna2 i szybkie
gojenie3 powodują że stent
SYNERGY™
jest świetną opcją do
CTO4 i pnia LTW.
1.
2.
3.
4.
Labeled Post-Dilatation Limits. SYNERGY Stent DFU
Bench testing performed by Boston Scientific Corporation. Data on file at Boston Scientific. All stents 2.5mm. SYNERGY Stent n=5, all other stents are n=3. Bench test results
not necessarily indicative of clinical performance.
EVOLVE Clinical trial at 4 year. Presented by Ian T. Meredith AM, MBBS, PhD, PCR 2015. Only the “full dose” SYNERGY Stent results are shown. EVOLVE II Clinical Trial.
Presented by Dean J. Kereiakes, MD at AHA 2014. EVOLVE II DM Clinical Trial. Presented by Stefann Windecker, MD at PCR 2015. Adapted from a presentation by J. M. de
la Torre, MD at PCR 2015. Wilson G, MD. ACC 2011.
For treatment of occluded vessels, contrast visualization of the distal vessel to confirm position of guidewire within the lumen is recommended
The expanded indications (bifurcation, ISR, LM, OL and CTO) are for CE Mark countries only
© 2015 Boston Scientific Corporation or its affiliates. All rights reserved. This material is not for use in the U.S., France or Japan. IC-332103-AA JUL 2015 2 of 13
Stent SYNERGY™
Stent SYNERGY™
zapewnia gojenie
w ciągu trzech
miesięcy3
• Dzięki unikalnej geometrii
DES SYNERGY™ jest
optymalnym stentem do
bifurkacji5
1.
2.
3.
4.
5.
Labeled Post-Dilatation Limits. SYNERGY Stent DFU
Bench testing performed by Boston Scientific Corporation. Data on file at Boston Scientific. All stents 2.5mm. SYNERGY Stent n=5, all other stents are n=3. Bench test results
not necessarily indicative of clinical performance.
EVOLVE Clinical trial at 4 year. Presented by Ian T. Meredith AM, MBBS, PhD, PCR 2015. Only the “full dose” SYNERGY Stent results are shown. EVOLVE II Clinical Trial.
Presented by Dean J. Kereiakes, MD at AHA 2014. EVOLVE II DM Clinical Trial. Presented by Stefann Windecker, MD at PCR 2015. Adapted from a presentation by J. M. de
la Torre, MD at PCR 2015. Wilson G, MD. ACC 2011.
For treatment of occluded vessels, contrast visualization of the distal vessel to confirm position of guidewire within the lumen is recommended
When treating Bifurcations, care must be exercised to access the secondary vessel via the repeating geometry in the body of the stent within the primary vessel.
The expanded indications (bifurcation, ISR, LM, OL and CTO) are for CE Mark countries only
© 2015 Boston Scientific Corporation or its affiliates. All rights reserved. This material is not for use in the U.S., France or Japan. IC-332103-AA JUL 2015 2 of 13
SYNERGY™
Nowe zarejestrowane wskazania
CE Mark
Diabetycy
Zmiany ostialne
Niezabepieczony pień lewej tętnicy
wieńcowej
Okluzje1
Restenoza w stencie2
Zawał
Bifurkacje3
1.
2.
For treatment of occluded vessels, contrast visualization of the distal vessel to confirm position of guidewire within the lumen is recommended.
For in stent restenosis, where details of the original stent are known, the expanded inner diameter of the new stent should not exceed the dilation limits of the original stent.
Where details of the original stent are not known, the expanded inner diameter of the new stent should not exceed the reference vessel diameter.
3. When treating Bifurcations, care must be exercised to access the secondary vessel via the repeating geometry in the body of the stent within the primary vessel.
Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Information for the use only in countries with
applicable health authority product registrations.
The expanded indications (bifurcation, ISR, LM, OL and CTO) are for CE Mark countries only
© 2015 Boston Scientific Corporation or its affiliates. All rights reserved. This material is not for use in the U.S., France or Japan. IC-332103-AA JUL 2015 3 of 13
SYNERGY™ zakres postdylatacji1
4,00mm → 5,75mm
(mm)
2.25
2.50
2.75
3.00
3.25
3.50
3.75
4.00
4.25
4.50
4.75
5.00
5.25
5.50
5.75
2.25 to 2.75
SYNERGY
Stent System
3.00 to 3.50
4.00
2.25
Promus
PREMIER™ Stent
System
2.50 to 2.75
3.00 to 3.50
4.00
2.25 to 2.50
Xience
Xpedition™/Alpine™
Stent System
Resolute
Integrity™
Stent System
2.75 to 3.25
3.50 to 4.00
2.25 to 2.75
3.00 to 4.00
2.25 to 2.50
Resolute Onyx™
Stent System
2.75 to 3.00
3.50 to 4.00
Labeled Nominal:
Labeled Post-Dil Limit:
1.
SYNERGY Stent, Promus PREMIER Stent, Xience Xpedition Stent, Xience Alpine Stent, Resolute Integrity Stent and Resolute Onyx Stent Systems DFU.
© 2015 Boston Scientific Corporation or its affiliates. All rights reserved. This material is not for use in the U.S., France or Japan. IC-332103-AA JUL 2015 7 of 13
Stent SYNERGY™
Szybkie gojenie
DES SYNERGY™ zapewnia gojenie w ciągu 3 miesięcy oraz
niskie ryzyko MACE u pacjentów złożonych1,2,3,4
Pokrycie 94% powierzchni stentu
w ciągu 3 miesięcy u pacjentów
z chorobą wielonaczyniową1
1.
2.
3.
4.
Adapted from a presentation by J. M. de la Torre, MD at PCR 2015. The safety and performance of the SYNERGY Stent System
have not been established in patients with multi-vessel diseases. And pre-clinical study Wilson G, MD. ACC 2011.
EVOLVE Clinical trial at 4 year. Presented by Ian T. Meredith AM, MBBS, PhD, PCR 2015. Only the “full dose” SYNERGY Stent results are shown.
EVOLVE II Clinical Trial. Presented by Dean J. Kereiakes, MD at AHA 2014.
EVOLVE II Diabetes Substudy . Presented by Stefann Windecker, MD at PCR 2015.
© 2015 Boston Scientific Corporation or its affiliates. All rights reserved. This material is not for use in the U.S., France or Japan. IC-332103-AA JUL 2015 11 of 13
Stent SYNERGY™
Szybkie gojenie
DES SYNERGY™ zapewnia gojenie w ciągu 3 miesięcy oraz
niskie ryzyko MACE u pacjentów złożonych1,2,2,4
0% zakrzepicy po 4 latach w EVOLVE2
0% zakrzepicy po 24 godzinach
w badaniu klinicznym EVOLVE II3
1.
2.
3.
4.
Adapted from a presentation by J. M. de la Torre, MD at PCR 2015. The safety and performance of the SYNERGY Stent System
have not been established in patients with multi-vessel diseases. And pre-clinical study Wilson G, MD. ACC 2011.
EVOLVE Clinical trial at 4 year. Presented by Ian T. Meredith AM, MBBS, PhD, PCR 2015. Only the “full dose” SYNERGY Stent results are shown.
EVOLVE II Clinical Trial. Presented by Dean J. Kereiakes, MD at AHA 2014.
EVOLVE II Diabetes Substudy . Presented by Stefann Windecker, MD at PCR 2015.
© 2015 Boston Scientific Corporation or its affiliates. All rights reserved. This material is not for use in the U.S., France or Japan. IC-332103-AA JUL 2015 11 of 13
Stent SYNERGY™
Szybkie gojenie
DES SYNERGY™ zapewnia gojenie w ciągu 3 miesięcy oraz
niskie ryzyko MACE u pacjentów złożonych1,2,3,4
1,1% zakrzepicy w EVOLVE II
u diabetyków4 po 12 miesiącach
1.
2.
3.
4.
Adapted from a presentation by J. M. de la Torre, MD at PCR 2015. The safety and performance of the SYNERGY Stent System
have not been established in patients with multi-vessel diseases. And pre-clinical study Wilson G, MD. ACC 2011.
EVOLVE Clinical trial at 4 year. Presented by Ian T. Meredith AM, MBBS, PhD, PCR 2015. Only the “full dose” SYNERGY Stent results are shown.
EVOLVE II Clinical Trial. Presented by Dean J. Kereiakes, MD at AHA 2014.
EVOLVE II Diabetes Substudy . Presented by Stefann Windecker, MD at PCR 2015.
© 2015 Boston Scientific Corporation or its affiliates. All rights reserved. This material is not for use in the U.S., France or Japan. IC-332103-AA JUL 2015 11 of 13
Stent SYNERGY™
Możliwość skrócenia DAPT do 1 miesiąca
Thin Abluminal Coating
^ The updated Directions for Use will also include an update on the current “Pre-and Post-Procedure Antiplatelet Regimen”:
In selected higher risk patients where the physician determines that the risks outweigh the benefits of continued DAPT, it may be reasonable to interrupt or discontinue therapy after 1
month based on low stent thrombosis rates and no observed increased risk for stent thrombosis as shown in the current literature. Patients who require premature discontinuation of
antiplatelet therapy should be monitored closely and have their antiplatelet therapy restarted as soon as possible per the discretion of their treating physicians
This material is not for use in the U.S., France or Japan.
IC-215308-AG OCT2015 11 of 84