Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements...
Transcript of Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements...
![Page 1: Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements of the Biotronik Orsiro Drug Eluting Stent Peter Monteleone MD, FACC, FSCAI 11.2020](https://reader036.fdocuments.us/reader036/viewer/2022071419/611806fac2727c2df8264c35/html5/thumbnails/1.jpg)
Engineering Drives Performance:
Design Elements of the Biotronik Orsiro Drug Eluting Stent
Peter Monteleone MD, FACC, FSCAI
11.2020
![Page 2: Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements of the Biotronik Orsiro Drug Eluting Stent Peter Monteleone MD, FACC, FSCAI 11.2020](https://reader036.fdocuments.us/reader036/viewer/2022071419/611806fac2727c2df8264c35/html5/thumbnails/2.jpg)
Orsiro Ultrathin Strut (BP‐SES) Clinical Evidence – Selected Trials
For internal use only.
Orsiro Competitor
![Page 3: Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements of the Biotronik Orsiro Drug Eluting Stent Peter Monteleone MD, FACC, FSCAI 11.2020](https://reader036.fdocuments.us/reader036/viewer/2022071419/611806fac2727c2df8264c35/html5/thumbnails/3.jpg)
Why???
![Page 4: Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements of the Biotronik Orsiro Drug Eluting Stent Peter Monteleone MD, FACC, FSCAI 11.2020](https://reader036.fdocuments.us/reader036/viewer/2022071419/611806fac2727c2df8264c35/html5/thumbnails/4.jpg)
innovation..
![Page 5: Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements of the Biotronik Orsiro Drug Eluting Stent Peter Monteleone MD, FACC, FSCAI 11.2020](https://reader036.fdocuments.us/reader036/viewer/2022071419/611806fac2727c2df8264c35/html5/thumbnails/5.jpg)
innovation..
![Page 6: Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements of the Biotronik Orsiro Drug Eluting Stent Peter Monteleone MD, FACC, FSCAI 11.2020](https://reader036.fdocuments.us/reader036/viewer/2022071419/611806fac2727c2df8264c35/html5/thumbnails/6.jpg)
![Page 7: Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements of the Biotronik Orsiro Drug Eluting Stent Peter Monteleone MD, FACC, FSCAI 11.2020](https://reader036.fdocuments.us/reader036/viewer/2022071419/611806fac2727c2df8264c35/html5/thumbnails/7.jpg)
seatbelt legislation
![Page 8: Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements of the Biotronik Orsiro Drug Eluting Stent Peter Monteleone MD, FACC, FSCAI 11.2020](https://reader036.fdocuments.us/reader036/viewer/2022071419/611806fac2727c2df8264c35/html5/thumbnails/8.jpg)
seatbelt legislationairbag implementation, 55 mph national speed limit
![Page 9: Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements of the Biotronik Orsiro Drug Eluting Stent Peter Monteleone MD, FACC, FSCAI 11.2020](https://reader036.fdocuments.us/reader036/viewer/2022071419/611806fac2727c2df8264c35/html5/thumbnails/9.jpg)
seatbelt legislationairbag implementation, 55 mph national speed limit
NHTSA crashworthiness vehicle ratings
![Page 10: Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements of the Biotronik Orsiro Drug Eluting Stent Peter Monteleone MD, FACC, FSCAI 11.2020](https://reader036.fdocuments.us/reader036/viewer/2022071419/611806fac2727c2df8264c35/html5/thumbnails/10.jpg)
seatbelt legislationairbag implementation, 55 mph national speed limit
NHTSA crashworthiness vehicle ratingstexting!!
![Page 11: Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements of the Biotronik Orsiro Drug Eluting Stent Peter Monteleone MD, FACC, FSCAI 11.2020](https://reader036.fdocuments.us/reader036/viewer/2022071419/611806fac2727c2df8264c35/html5/thumbnails/11.jpg)
stentingdrug eluting stent
cobalt chromium
HYPOTHETICAL
freedom from TLF
year
![Page 12: Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements of the Biotronik Orsiro Drug Eluting Stent Peter Monteleone MD, FACC, FSCAI 11.2020](https://reader036.fdocuments.us/reader036/viewer/2022071419/611806fac2727c2df8264c35/html5/thumbnails/12.jpg)
HYPOTHETICAL
freedom from TLF
year
![Page 13: Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements of the Biotronik Orsiro Drug Eluting Stent Peter Monteleone MD, FACC, FSCAI 11.2020](https://reader036.fdocuments.us/reader036/viewer/2022071419/611806fac2727c2df8264c35/html5/thumbnails/13.jpg)
Why?
![Page 14: Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements of the Biotronik Orsiro Drug Eluting Stent Peter Monteleone MD, FACC, FSCAI 11.2020](https://reader036.fdocuments.us/reader036/viewer/2022071419/611806fac2727c2df8264c35/html5/thumbnails/14.jpg)
Biotronik Orsiroengineering OPTIMIZATION
![Page 15: Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements of the Biotronik Orsiro Drug Eluting Stent Peter Monteleone MD, FACC, FSCAI 11.2020](https://reader036.fdocuments.us/reader036/viewer/2022071419/611806fac2727c2df8264c35/html5/thumbnails/15.jpg)
Biotronik Orsiroengineering OPTIMIZATION
• sirolimus• ultrathin struts• BIOlute active coating• ProBIO passive coating• catheter characteristics
![Page 16: Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements of the Biotronik Orsiro Drug Eluting Stent Peter Monteleone MD, FACC, FSCAI 11.2020](https://reader036.fdocuments.us/reader036/viewer/2022071419/611806fac2727c2df8264c35/html5/thumbnails/16.jpg)
Biotronik Orsiroengineering OPTIMIZATION
• sirolimus• ultrathin struts• BIOlute active coating• ProBIO passive coating• catheter characteristics
![Page 17: Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements of the Biotronik Orsiro Drug Eluting Stent Peter Monteleone MD, FACC, FSCAI 11.2020](https://reader036.fdocuments.us/reader036/viewer/2022071419/611806fac2727c2df8264c35/html5/thumbnails/17.jpg)
![Page 18: Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements of the Biotronik Orsiro Drug Eluting Stent Peter Monteleone MD, FACC, FSCAI 11.2020](https://reader036.fdocuments.us/reader036/viewer/2022071419/611806fac2727c2df8264c35/html5/thumbnails/18.jpg)
![Page 19: Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements of the Biotronik Orsiro Drug Eluting Stent Peter Monteleone MD, FACC, FSCAI 11.2020](https://reader036.fdocuments.us/reader036/viewer/2022071419/611806fac2727c2df8264c35/html5/thumbnails/19.jpg)
EES Abbott Xience VSES Cordis Cypher Select +
![Page 20: Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements of the Biotronik Orsiro Drug Eluting Stent Peter Monteleone MD, FACC, FSCAI 11.2020](https://reader036.fdocuments.us/reader036/viewer/2022071419/611806fac2727c2df8264c35/html5/thumbnails/20.jpg)
EES Abbott Xience VSES Cordis Cypher Select +
![Page 21: Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements of the Biotronik Orsiro Drug Eluting Stent Peter Monteleone MD, FACC, FSCAI 11.2020](https://reader036.fdocuments.us/reader036/viewer/2022071419/611806fac2727c2df8264c35/html5/thumbnails/21.jpg)
EES Abbott Xience VSES Cordis Cypher Select +
![Page 22: Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements of the Biotronik Orsiro Drug Eluting Stent Peter Monteleone MD, FACC, FSCAI 11.2020](https://reader036.fdocuments.us/reader036/viewer/2022071419/611806fac2727c2df8264c35/html5/thumbnails/22.jpg)
SORT‐OUT IV
BIOFLOW V
![Page 23: Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements of the Biotronik Orsiro Drug Eluting Stent Peter Monteleone MD, FACC, FSCAI 11.2020](https://reader036.fdocuments.us/reader036/viewer/2022071419/611806fac2727c2df8264c35/html5/thumbnails/23.jpg)
Biotronik Orsiroengineering OPTIMIZATION
• sirolimus• though a well proven drug for DES• the benefit of Orsiro “is (probably) not about the drug…”
![Page 24: Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements of the Biotronik Orsiro Drug Eluting Stent Peter Monteleone MD, FACC, FSCAI 11.2020](https://reader036.fdocuments.us/reader036/viewer/2022071419/611806fac2727c2df8264c35/html5/thumbnails/24.jpg)
Biotronik Orsiroengineering OPTIMIZATION
• sirolimus• ultrathin struts• BIOlute active coating• ProBIO passive coating• catheter characteristics
![Page 25: Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements of the Biotronik Orsiro Drug Eluting Stent Peter Monteleone MD, FACC, FSCAI 11.2020](https://reader036.fdocuments.us/reader036/viewer/2022071419/611806fac2727c2df8264c35/html5/thumbnails/25.jpg)
ultrathin struts• PRO‐Kinetic Energy BMS scaffold• Cobalt‐chromium L605• “ultrathin”
• 60 micrometers for stents <=3.0 mm in diameter• 80 micrometers for stent diameters >3.0 mm
• 81 Abbott Xience• 74 Boston Scientific's Synergy • 81 Medtronic Resolute Onyx is 81
![Page 26: Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements of the Biotronik Orsiro Drug Eluting Stent Peter Monteleone MD, FACC, FSCAI 11.2020](https://reader036.fdocuments.us/reader036/viewer/2022071419/611806fac2727c2df8264c35/html5/thumbnails/26.jpg)
• 1. BIOTRONIK Data on file• *Synergy is a registered trademark of Boston Scientific.• Disclaimer: Information on devices manufactured at companies other than BIOTRONIK was gathered from multiple sources. However, it has not been verified by the vendors
and we cannot guarantee its accuracy.
Double Helix Stent Design for a Smooth Outer Contour and Improved Flexibility
26
Smooth outer contour
Two helical meandersExcellent flexibility andsmooth crimped profile
Wedge shaped transitionsConsistent scaffolding through entire stent
Ring elementDefined stent length
Three longitudinal connectors per helixDesigned to minimize foreshortening and resist longitudinal compression
Orsiro
SynergyBoston Scientific
![Page 27: Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements of the Biotronik Orsiro Drug Eluting Stent Peter Monteleone MD, FACC, FSCAI 11.2020](https://reader036.fdocuments.us/reader036/viewer/2022071419/611806fac2727c2df8264c35/html5/thumbnails/27.jpg)
ultrathin struts • Preclinical studies demonstrate a 1.5x increase in thrombogenicity of thick-strut
stents (162 micrometer) versus identical thinner strut stents (81 micrometer). 1,2
• In vivo, flow stagnation and neointimal fibrin deposition drive a 60% increase in thrombus formation and neointimal fibrin deposition at 3 days in thick versus thin strut stent systems.2
• Stent endothelialization occurs faster with thin struts likely due simply to a smaller area needed requiring coverage. 1,3
• Thick-strut scaffolds induce greater inflammation, vessel injury, internal elastic lamina disruption, in-stent neointmal growth and hyperplasia. 1,4,5
• ISAR-STEREO-1 and 2 demonstrated that angiographic and clinical restenosis could be reduced with utilization of thin strut stents.6,7
![Page 28: Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements of the Biotronik Orsiro Drug Eluting Stent Peter Monteleone MD, FACC, FSCAI 11.2020](https://reader036.fdocuments.us/reader036/viewer/2022071419/611806fac2727c2df8264c35/html5/thumbnails/28.jpg)
engineering OPTIMIZATION• sirolimus• ultrathin struts• BIOlute active coating• ProBIO passive coating• catheter characteristics
![Page 29: Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements of the Biotronik Orsiro Drug Eluting Stent Peter Monteleone MD, FACC, FSCAI 11.2020](https://reader036.fdocuments.us/reader036/viewer/2022071419/611806fac2727c2df8264c35/html5/thumbnails/29.jpg)
BIOlute active coating• The outermost cover of the Orsiro stent is the BIOlute active coating made of biodegradable poly‐L‐lactic acid (PLLA) loaded with sirolimus
• PLLA undergoes metabolism via the Krebs cycle into carbon dioxide and water, and completely degrades over 12–15 months
• The slow degradation of PLLA allows for the controlled release of sirolimus
• It is this attribute that categorizes the Orsiro device as a biodegradable polymer DES
![Page 30: Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements of the Biotronik Orsiro Drug Eluting Stent Peter Monteleone MD, FACC, FSCAI 11.2020](https://reader036.fdocuments.us/reader036/viewer/2022071419/611806fac2727c2df8264c35/html5/thumbnails/30.jpg)
BIOlute active coating• Histopathology studies demonstrate decreased inflammation, improved re‐endothelialization, reduced neointimal growth and adequate drug sirolimus tissue concentration with PLLA biodegradable by comparison to permanent polymer‐based sirolimus‐eluting platforms
• Direct comparative clinical studies remain to be completed
Koppara T, Joner M, Bayer G, Steigerwald K, Diener T, Wittchow E. Histopathological comparison of biodegradable polymer and permanent polymer based sirolimus eluting stents in a porcine model of coronary stent implantation. Thromb Haemost. 2012;107(6):1161‐1171.
![Page 31: Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements of the Biotronik Orsiro Drug Eluting Stent Peter Monteleone MD, FACC, FSCAI 11.2020](https://reader036.fdocuments.us/reader036/viewer/2022071419/611806fac2727c2df8264c35/html5/thumbnails/31.jpg)
• 1. BIOTRONIK data on file.• 2. TittelbachM, Diener T. Orsiro – The First Hybrid Drug‐eluting Stent, Opening Up a New Class of Drug‐eluting Stents for Superior Patient Outcomes. Interventional Cardiology. 2011; 6(2): 1‐5.
Coating Composition
1) Controlled drug release1,2
• Drug elution from BIOlute starts immediately following implantation
• Majority of sirolimus is released within three months
• Nearly complete elution is achieved within 1 year
2) Bioabsorption1,2
• The BIOlute drug matrix is gradually absorbed by the body
• A substantial amount of the polymer is degraded within two years
Controlled drug release, gentle absorption and low ion release
![Page 32: Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements of the Biotronik Orsiro Drug Eluting Stent Peter Monteleone MD, FACC, FSCAI 11.2020](https://reader036.fdocuments.us/reader036/viewer/2022071419/611806fac2727c2df8264c35/html5/thumbnails/32.jpg)
engineering OPTIMIZATION• sirolimus• ultrathin struts• BIOlute active coating• ProBIO passive coating• catheter characteristics
![Page 33: Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements of the Biotronik Orsiro Drug Eluting Stent Peter Monteleone MD, FACC, FSCAI 11.2020](https://reader036.fdocuments.us/reader036/viewer/2022071419/611806fac2727c2df8264c35/html5/thumbnails/33.jpg)
• 1. BIOTRONIK data on file.• 2. TittelbachM, Diener T. Orsiro – The First Hybrid Drug‐eluting Stent, Opening Up a New Class of Drug‐eluting Stents for Superior Patient Outcomes. Interventional Cardiology. 2011; 6(2): 1‐5.
Coating Composition
3) Inert backbone1,2
• proBIO passive coating encapsulates the stent, reducing interaction between the metal stent and the surrounding tissue
• In vitro studies have shown up to a 98% reduction of metal ion release when the stent surface is coated with proBIO
Controlled drug release, gentle absorption and low ion release
![Page 34: Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements of the Biotronik Orsiro Drug Eluting Stent Peter Monteleone MD, FACC, FSCAI 11.2020](https://reader036.fdocuments.us/reader036/viewer/2022071419/611806fac2727c2df8264c35/html5/thumbnails/34.jpg)
proBIO passive coating• 80 nanometer-thin layer seals the scaffold surface and eliminates
interaction between the metal and the surrounding tissue of the treated artery
• composed of an amorphous hydrogen-rich silicon carbide that is deposited onto the stent through a plasma-enhanced chemical vapor deposition technique that bonds the inert coating to the metal surface
• lowers the rate of corrosion of the stent and decreases tissue inflammation including from allergic reactions to the metal.
• the semi-conductive silicon carbide coating has demonstrated up to a 98% reduction of allergenic metal ion release
• ProBIO coating does not biodegrade and is thus considered passive
![Page 35: Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements of the Biotronik Orsiro Drug Eluting Stent Peter Monteleone MD, FACC, FSCAI 11.2020](https://reader036.fdocuments.us/reader036/viewer/2022071419/611806fac2727c2df8264c35/html5/thumbnails/35.jpg)
TM
1. Rzany A, et al. Smart Material Silicon Carbide: Reduced Activation of Cells and Proteins on a‐SiC:H‐coated Stainless Steel. Progress in Biomedical Research 2001; May: 182‐194
proBIO Passive Coating
50.8
14.9
6.40.9
0
10
20
30
40
50
60
CoNi PtCr CoCr CoCr withproBIO
Mass o
f Nickel release per su
rface area
[ng/cm
2 ]
-98%
-94%
-68%
Reduced nickel ion release compared to other stent platforms1
![Page 36: Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements of the Biotronik Orsiro Drug Eluting Stent Peter Monteleone MD, FACC, FSCAI 11.2020](https://reader036.fdocuments.us/reader036/viewer/2022071419/611806fac2727c2df8264c35/html5/thumbnails/36.jpg)
engineering OPTIMIZATION• sirolimus• ultrathin struts• BIOlute active coating• ProBIO passive coating• catheter characteristics
![Page 37: Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements of the Biotronik Orsiro Drug Eluting Stent Peter Monteleone MD, FACC, FSCAI 11.2020](https://reader036.fdocuments.us/reader036/viewer/2022071419/611806fac2727c2df8264c35/html5/thumbnails/37.jpg)
delivering the engineering• Longer length monorail catheter redesign versus
competitor devices• Improved “push,” “cross” and “crossing profile”
Kalnins U, Erglis A, Dinne I, Kumsars I, Jegere S. Clinicaloutcomes of silicon carbide coated stents in patients withcoronary artery disease. Med Sci Monit. 2002;8(2):PI16‐20.
BIOTRONIK data on file. IIB (P) 24/2018.
![Page 38: Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements of the Biotronik Orsiro Drug Eluting Stent Peter Monteleone MD, FACC, FSCAI 11.2020](https://reader036.fdocuments.us/reader036/viewer/2022071419/611806fac2727c2df8264c35/html5/thumbnails/38.jpg)
44.0
36.4
29.7
51.2
20.0 25.0 30.0 35.0 40.0 45.0 50.0 55.0
Better Push
• 1. BIORONIK data on file. IIB (P) 24/2018
OrsiroBIOTRONIK
Resolute OnyxMedtronic
SynergyBoston Scientific
Xience SierraAbbott
Better Push72%
+72%
Transmits up to 72% more force from hub to tip1
Relative force transmitted (%)
![Page 39: Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements of the Biotronik Orsiro Drug Eluting Stent Peter Monteleone MD, FACC, FSCAI 11.2020](https://reader036.fdocuments.us/reader036/viewer/2022071419/611806fac2727c2df8264c35/html5/thumbnails/39.jpg)
Easier Cross
0.14
0.15
0.24
0.05
0.00 0.05 0.10 0.15 0.20 0.25 0.30Resistance (N)
-79%Orsiro
BIOTRONIK
SynergyBoston Scientific
Resolute OnyxMedtronic
Xience SierraAbbott
Less Force79%
Up to 79% less force needed to successfully cross demanding anatomies1
![Page 40: Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements of the Biotronik Orsiro Drug Eluting Stent Peter Monteleone MD, FACC, FSCAI 11.2020](https://reader036.fdocuments.us/reader036/viewer/2022071419/611806fac2727c2df8264c35/html5/thumbnails/40.jpg)
Lower Crossing Profile
Improved acute performance – up to 7% lower crossing profile1
1.01
1.01
1.02
0.95
0.90 0.92 0.94 0.96 0.98 1.00 1.02 1.04Crossing profile (mm)
-7%Orsiro
BIOTRONIK
Resolute OnyxMedtronic
SynergyBoston Scientific
Xience SierraAbbott
Lower Crossing Profile7%
![Page 41: Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements of the Biotronik Orsiro Drug Eluting Stent Peter Monteleone MD, FACC, FSCAI 11.2020](https://reader036.fdocuments.us/reader036/viewer/2022071419/611806fac2727c2df8264c35/html5/thumbnails/41.jpg)
HYPOTHETICAL
freedom from TLF
year
![Page 42: Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements of the Biotronik Orsiro Drug Eluting Stent Peter Monteleone MD, FACC, FSCAI 11.2020](https://reader036.fdocuments.us/reader036/viewer/2022071419/611806fac2727c2df8264c35/html5/thumbnails/42.jpg)
• 153 clinical sites• 21 states and Washington DC
CV Service Line
![Page 43: Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements of the Biotronik Orsiro Drug Eluting Stent Peter Monteleone MD, FACC, FSCAI 11.2020](https://reader036.fdocuments.us/reader036/viewer/2022071419/611806fac2727c2df8264c35/html5/thumbnails/43.jpg)
• * TLF components as per respective definitions in trials.
Orsiro Ultrathin Strut (BP‐SES) Clinical Evidence – Selected Trials
Randomized controlled trials Bioabsorbable Polymer (BP) SES compared to Durable Polymer (DP) EES/ZES
For internal use only.
• Absolute risk reduction = 1.6%• NNT = 63• For Ascension’s 8181 annual STEMI
volume that would mean 130 TLF prevented in 1 year in the highest risk PCI cohort of STEMI
![Page 44: Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements of the Biotronik Orsiro Drug Eluting Stent Peter Monteleone MD, FACC, FSCAI 11.2020](https://reader036.fdocuments.us/reader036/viewer/2022071419/611806fac2727c2df8264c35/html5/thumbnails/44.jpg)
• * TLF components as per respective definitions in trials.
Orsiro Ultrathin Strut (BP‐SES) Clinical Evidence – Selected Trials
Randomized controlled trials Bioabsorbable Polymer (BP) SES compared to Durable Polymer (DP) EES/ZES
For internal use only.
• Absolute risk reduction = 3.4%• NNT = 29• For Ascension’s 16212 annual PCI
volume that would mean 559 TLF prevented in 1 year
![Page 45: Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements of the Biotronik Orsiro Drug Eluting Stent Peter Monteleone MD, FACC, FSCAI 11.2020](https://reader036.fdocuments.us/reader036/viewer/2022071419/611806fac2727c2df8264c35/html5/thumbnails/45.jpg)
72yoM presented with lateral STEMI
![Page 46: Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements of the Biotronik Orsiro Drug Eluting Stent Peter Monteleone MD, FACC, FSCAI 11.2020](https://reader036.fdocuments.us/reader036/viewer/2022071419/611806fac2727c2df8264c35/html5/thumbnails/46.jpg)
Residual serial LAD lesions staged
![Page 47: Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements of the Biotronik Orsiro Drug Eluting Stent Peter Monteleone MD, FACC, FSCAI 11.2020](https://reader036.fdocuments.us/reader036/viewer/2022071419/611806fac2727c2df8264c35/html5/thumbnails/47.jpg)
12.6.19
![Page 48: Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements of the Biotronik Orsiro Drug Eluting Stent Peter Monteleone MD, FACC, FSCAI 11.2020](https://reader036.fdocuments.us/reader036/viewer/2022071419/611806fac2727c2df8264c35/html5/thumbnails/48.jpg)
OCT
![Page 49: Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements of the Biotronik Orsiro Drug Eluting Stent Peter Monteleone MD, FACC, FSCAI 11.2020](https://reader036.fdocuments.us/reader036/viewer/2022071419/611806fac2727c2df8264c35/html5/thumbnails/49.jpg)
![Page 50: Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements of the Biotronik Orsiro Drug Eluting Stent Peter Monteleone MD, FACC, FSCAI 11.2020](https://reader036.fdocuments.us/reader036/viewer/2022071419/611806fac2727c2df8264c35/html5/thumbnails/50.jpg)
2.5x26 Orsiro DES
![Page 51: Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements of the Biotronik Orsiro Drug Eluting Stent Peter Monteleone MD, FACC, FSCAI 11.2020](https://reader036.fdocuments.us/reader036/viewer/2022071419/611806fac2727c2df8264c35/html5/thumbnails/51.jpg)
2.5x12 NC post-dilatation
![Page 52: Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements of the Biotronik Orsiro Drug Eluting Stent Peter Monteleone MD, FACC, FSCAI 11.2020](https://reader036.fdocuments.us/reader036/viewer/2022071419/611806fac2727c2df8264c35/html5/thumbnails/52.jpg)
3.0x35 Orsiro DES proximal LAD
![Page 53: Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements of the Biotronik Orsiro Drug Eluting Stent Peter Monteleone MD, FACC, FSCAI 11.2020](https://reader036.fdocuments.us/reader036/viewer/2022071419/611806fac2727c2df8264c35/html5/thumbnails/53.jpg)
Post OCT
![Page 54: Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements of the Biotronik Orsiro Drug Eluting Stent Peter Monteleone MD, FACC, FSCAI 11.2020](https://reader036.fdocuments.us/reader036/viewer/2022071419/611806fac2727c2df8264c35/html5/thumbnails/54.jpg)
![Page 55: Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements of the Biotronik Orsiro Drug Eluting Stent Peter Monteleone MD, FACC, FSCAI 11.2020](https://reader036.fdocuments.us/reader036/viewer/2022071419/611806fac2727c2df8264c35/html5/thumbnails/55.jpg)
3.0x12 NC post-dilatation distal stent
![Page 56: Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements of the Biotronik Orsiro Drug Eluting Stent Peter Monteleone MD, FACC, FSCAI 11.2020](https://reader036.fdocuments.us/reader036/viewer/2022071419/611806fac2727c2df8264c35/html5/thumbnails/56.jpg)
4.0x12 NC post-dilatation proximal
![Page 57: Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements of the Biotronik Orsiro Drug Eluting Stent Peter Monteleone MD, FACC, FSCAI 11.2020](https://reader036.fdocuments.us/reader036/viewer/2022071419/611806fac2727c2df8264c35/html5/thumbnails/57.jpg)
![Page 58: Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements of the Biotronik Orsiro Drug Eluting Stent Peter Monteleone MD, FACC, FSCAI 11.2020](https://reader036.fdocuments.us/reader036/viewer/2022071419/611806fac2727c2df8264c35/html5/thumbnails/58.jpg)
![Page 59: Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements of the Biotronik Orsiro Drug Eluting Stent Peter Monteleone MD, FACC, FSCAI 11.2020](https://reader036.fdocuments.us/reader036/viewer/2022071419/611806fac2727c2df8264c35/html5/thumbnails/59.jpg)
thank you!
![Page 60: Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements of the Biotronik Orsiro Drug Eluting Stent Peter Monteleone MD, FACC, FSCAI 11.2020](https://reader036.fdocuments.us/reader036/viewer/2022071419/611806fac2727c2df8264c35/html5/thumbnails/60.jpg)
references1. Iglesias JF, Roffi M, Degrauwe S, et al. Orsiro cobalt‐chromium sirolimus‐eluting stent: present and future perspectives. Expert Rev Med Devices. 2017;14(10):773‐788.2. Prabhu S, Schikorr T, Mahmoud T, Jacobs J, Potgieter A, Simonton C. Engineering assessment of the longitudinal compression behaviour of contemporary coronary stents. EuroIntervention. 2012;8(2):275‐281.3. Barragan P, Garitey V, Mouneimne K, Rieu R. Longitudinal compression behaviour of coronary stents: a bench‐top comparative study. EuroIntervention. 2014;9(12):1454‐1462.4. Kolandaivelu K, Swaminathan R, Gibson WJ, et al. Stent thrombogenicity early in high‐risk interventional settings is driven by stent design and deployment and protected by polymer‐drug coatings. Circulation. 2011;123(13):1400‐1409.5. Soucy NV, Feygin JM, Tunstall R, et al. Strut tissue coverage and endothelial cell coverage: a comparison between bare metal stent platforms and platinum chromium stents with and without everolimus‐eluting coating. EuroIntervention. 2010;6(5):630‐637.6 Farb A, Weber DK, Kolodgie FD, Burke AP, Virmani R. Morphological predictors of restenosis after coronary stenting in humans. Circulation. 2002;105(25):2974‐2980.7. Timmins LH, Miller MW, Clubb FJ, Jr., Moore JE, Jr. Increased artery wall stress post‐stenting leads to greater intimal thickening. Lab Invest. 2011;91(6):955‐967.
![Page 61: Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements of the Biotronik Orsiro Drug Eluting Stent Peter Monteleone MD, FACC, FSCAI 11.2020](https://reader036.fdocuments.us/reader036/viewer/2022071419/611806fac2727c2df8264c35/html5/thumbnails/61.jpg)