Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements...
Transcript of Engineering Drives Performance · 2020. 11. 14. · Engineering Drives Performance: Design Elements...
Engineering Drives Performance:
Design Elements of the Biotronik Orsiro Drug Eluting Stent
Peter Monteleone MD, FACC, FSCAI
11.2020
Orsiro Ultrathin Strut (BP‐SES) Clinical Evidence – Selected Trials
For internal use only.
Orsiro Competitor
Why???
innovation..
innovation..
seatbelt legislation
seatbelt legislationairbag implementation, 55 mph national speed limit
seatbelt legislationairbag implementation, 55 mph national speed limit
NHTSA crashworthiness vehicle ratings
seatbelt legislationairbag implementation, 55 mph national speed limit
NHTSA crashworthiness vehicle ratingstexting!!
stentingdrug eluting stent
cobalt chromium
HYPOTHETICAL
freedom from TLF
year
HYPOTHETICAL
freedom from TLF
year
Why?
Biotronik Orsiroengineering OPTIMIZATION
Biotronik Orsiroengineering OPTIMIZATION
• sirolimus• ultrathin struts• BIOlute active coating• ProBIO passive coating• catheter characteristics
Biotronik Orsiroengineering OPTIMIZATION
• sirolimus• ultrathin struts• BIOlute active coating• ProBIO passive coating• catheter characteristics
EES Abbott Xience VSES Cordis Cypher Select +
EES Abbott Xience VSES Cordis Cypher Select +
EES Abbott Xience VSES Cordis Cypher Select +
SORT‐OUT IV
BIOFLOW V
Biotronik Orsiroengineering OPTIMIZATION
• sirolimus• though a well proven drug for DES• the benefit of Orsiro “is (probably) not about the drug…”
Biotronik Orsiroengineering OPTIMIZATION
• sirolimus• ultrathin struts• BIOlute active coating• ProBIO passive coating• catheter characteristics
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
• 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
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
engineering OPTIMIZATION• sirolimus• ultrathin struts• BIOlute active coating• ProBIO passive coating• catheter characteristics
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
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.
• 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
engineering OPTIMIZATION• sirolimus• ultrathin struts• BIOlute active coating• ProBIO passive coating• catheter characteristics
• 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
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
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
engineering OPTIMIZATION• sirolimus• ultrathin struts• BIOlute active coating• ProBIO passive coating• catheter characteristics
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.
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 (%)
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
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%
HYPOTHETICAL
freedom from TLF
year
• 153 clinical sites• 21 states and Washington DC
CV Service Line
• * 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
• * 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
72yoM presented with lateral STEMI
Residual serial LAD lesions staged
12.6.19
OCT
2.5x26 Orsiro DES
2.5x12 NC post-dilatation
3.0x35 Orsiro DES proximal LAD
Post OCT
3.0x12 NC post-dilatation distal stent
4.0x12 NC post-dilatation proximal
thank you!
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.