IC AG OCT of 84

Transcription

1 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 AG OCT of 84

2 Stent SYNERGY PEWNE GOJENIE Konstrukcja pokrycie abluminalne 1 Szybkie gojenie 2 Skrócona obecność polimeru 3 Thin Abluminal Coating 1. Eppihimer M, PhD. Impact of Polymer Type and Location on Stent Thrombogenicity and Endothelial Cell Coverage. EuroPCR 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 This material is not for use in the U.S., France or Japan. IC AF MAY2015.

3 Stent SYNERGY This material is not for use in the U.S., France or Japan. IC AF MAY2015.

4 Stent SYNERGY DES SYNERGY zapewnia gojenie w ciągu trzech miesięcy 3 Możliwość przeprężenia 1, siła radialna 2 i szybkie gojenie 3 powodują że stent SYNERGY jest świetną opcją do CTO 4 i pnia LTW. 1. Labeled Post-Dilatation Limits. SYNERGY Stent DFU 2. 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. 3. EVOLVE Clinical trial at 4 year. Presented by Ian T. Meredith AM, MBBS, PhD, PCR Only the full dose SYNERGY Stent results are shown. EVOLVE II Clinical Trial. Presented by Dean J. Kereiakes, MD at AHA EVOLVE II DM Clinical Trial. Presented by Stefann Windecker, MD at PCR Adapted from a presentation by J. M. de la Torre, MD at PCR Wilson G, MD. ACC 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 AA JUL of 13

5 Stent SYNERGY Stent SYNERGY zapewnia gojenie w ciągu trzech miesięcy 3 Dzięki unikalnej geometrii DES SYNERGY jest optymalnym stentem do bifurkacji 5 1. Labeled Post-Dilatation Limits. SYNERGY Stent DFU 2. 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. 3. EVOLVE Clinical trial at 4 year. Presented by Ian T. Meredith AM, MBBS, PhD, PCR Only the full dose SYNERGY Stent results are shown. EVOLVE II Clinical Trial. Presented by Dean J. Kereiakes, MD at AHA EVOLVE II DM Clinical Trial. Presented by Stefann Windecker, MD at PCR Adapted from a presentation by J. M. de la Torre, MD at PCR Wilson G, MD. ACC For treatment of occluded vessels, contrast visualization of the distal vessel to confirm position of guidewire within the lumen is recommended 5. 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 AA JUL of 13

6 SYNERGY Nowe zarejestrowane wskazania CE Mark Diabetycy Zmiany ostialne Niezabepieczony pień lewej tętnicy wieńcowej Okluzje 1 Restenoza w stencie 2 Zawał Bifurkacje 3 1. For treatment of occluded vessels, contrast visualization of the distal vessel to confirm position of guidewire within the lumen is recommended. 2. 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 AA JUL of 13

7 SYNERGY zakres postdylatacji 1 4,00mm 5,75mm (mm) to 2.75 SYNERGY Stent System 3.00 to Promus PREMIER Stent System to to Xience Xpedition /Alpine Stent System 2.25 to to to 4.00 Resolute Integrity Stent System 2.25 to to 4.00 Resolute Onyx Stent System 2.25 to to 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 Boston Scientific Corporation or its affiliates. All rights reserved. This material is not for use in the U.S., France or Japan. IC AA JUL of 13

8 Stent SYNERGY Szybkie gojenie DES SYNERGY zapewnia gojenie w ciągu 3 miesięcy oraz niskie ryzyko MACE u pacjentów złożonych 1,2,3,4 Pokrycie 94% powierzchni stentu w ciągu 3 miesięcy u pacjentów z chorobą wielonaczyniową 1 1. Adapted from a presentation by J. M. de la Torre, MD at PCR 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 EVOLVE Clinical trial at 4 year. Presented by Ian T. Meredith AM, MBBS, PhD, PCR Only the full dose SYNERGY Stent results are shown. 3. EVOLVE II Clinical Trial. Presented by Dean J. Kereiakes, MD at AHA EVOLVE II Diabetes Substudy. Presented by Stefann Windecker, MD at PCR Boston Scientific Corporation or its affiliates. All rights reserved. This material is not for use in the U.S., France or Japan. IC AA JUL of 13

9 Stent SYNERGY Szybkie gojenie DES SYNERGY zapewnia gojenie w ciągu 3 miesięcy oraz niskie ryzyko MACE u pacjentów złożonych 1,2,2,4 0% zakrzepicy po 4 latach w EVOLVE 2 0% zakrzepicy po 24 godzinach w badaniu klinicznym EVOLVE II 3 1. Adapted from a presentation by J. M. de la Torre, MD at PCR 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 EVOLVE Clinical trial at 4 year. Presented by Ian T. Meredith AM, MBBS, PhD, PCR Only the full dose SYNERGY Stent results are shown. 3. EVOLVE II Clinical Trial. Presented by Dean J. Kereiakes, MD at AHA EVOLVE II Diabetes Substudy. Presented by Stefann Windecker, MD at PCR Boston Scientific Corporation or its affiliates. All rights reserved. This material is not for use in the U.S., France or Japan. IC AA JUL of 13

10 Stent SYNERGY Szybkie gojenie DES SYNERGY zapewnia gojenie w ciągu 3 miesięcy oraz niskie ryzyko MACE u pacjentów złożonych 1,2,3,4 1,1% zakrzepicy w EVOLVE II u diabetyków 4 po 12 miesiącach 1. Adapted from a presentation by J. M. de la Torre, MD at PCR 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 EVOLVE Clinical trial at 4 year. Presented by Ian T. Meredith AM, MBBS, PhD, PCR Only the full dose SYNERGY Stent results are shown. 3. EVOLVE II Clinical Trial. Presented by Dean J. Kereiakes, MD at AHA EVOLVE II Diabetes Substudy. Presented by Stefann Windecker, MD at PCR Boston Scientific Corporation or its affiliates. All rights reserved. This material is not for use in the U.S., France or Japan. IC AA JUL of 13

11 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 AG OCT of 84