orsiro 2013
TRANSCRIPT
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Dr. José Alfredo Merino Rajme
Cardiología clínica e intervencionista CMN 20 de Noviembre ISSSTE, México
BIOTRONIK VI
Orsiro
Orsiro. Primer Stent liberador de fármaco Hibrido
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Declaración de conflicto de intereses
• Astra Zeneca Advisory Board
• Pfizer Advisory board
• Novartis Speaker
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Orsiro DES
“Historia de una nueva plataforma que transporta a un viejo amigo”
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Industry’s first hybrid drug-eluting stent with a bioabsorbable polymer
PK Energy (60μm) stent strut
PROBIO® passive coating BIOlute® active coating
An ideal combination of passive and active components
Hybrid design
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El Stent: Orsiro Hybrid Drug Eluting Stent
• PROBIO® recubrimiento pasivo que encapsula al stent y minimiza la interacción entre el stent y el endotelio
• BIOlute® recubrimiento activo con un polímero biocompatible que libera un sirolimus a través de una matriz biodegradable
• Excelente navegavilidad que le confiere la plataforma de PRO-Kinetic Energy Stent System para tratar lesiones complejas.
BIOlute® logra una liberación controlada del fármaco
The BIOlute®gentilmente se degrada a CO2 y H2O
Solo queda el recubrimiento de PROBIO® sellando el stent que está en contacto con la arteria
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Passive: PROBIO es un aislante siliconado del stent
PROBIO Reduce de manera significativa la interacción entre tejidos y metal.
Reducción del 96% de iones alergénicos
with ease
Competitor A
cobalt nickel alloy
Competitor B
cobalt chromium alloy
Cobalt Nickel Tungsten Chromium
PRO-Kinetic Energy
with PROBIO® coating
25 000
20 000
15 000
10 000
5 000
0
Con
cen
trati
on
in n
g/l
PROBIO® sil icon carbide coating
PROBIO® acts as a diffusion barrier, sealing the bare metal surface and
reducing ion release. In vitro studies have shown up to a 96 % reduction
of allergic metal ions when the stent surface is coated with silicon carbide.
Passive components
Our market leading PRO-Kinetic
Energy stent system provides
superior deliverability with state-of-
the-art design, encapsulated within
our PROBIO® passive coating that
eliminates interaction between the
metal stent and the surrounding tissue.
Active component
Our active bioabsorbable polymer
coating BIOlute® , contains a Limus
drug and utilizes the advantage of
controlled drug release from a highly
biocompatible polymer matrix. In the
long term, the patient is l eft with only
a PROBIO® coated stent.
hybrid
coating
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BIOlute permite control preciso de las propiedades mecánicas y farmacológicas
La cinética de la liberación es controlada por el proceso de recubrimiento, no son necesarios recubrimientos adicionales
Concentración de fármaco en superficie del strut de 1.4 µg/mm2.
Las propiedades mecánicas son adecuadas debido a la fuerza del polímero
60μm
7.4μm
3.5μm
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BIOlute
Estudios en vivo muestran completa liberacón del sirolimus entre 90 y 100 días.
La curva de liberación se encuentra adecuada en comparación con otros DES
* Residual drug remaining of stent after explantation. Data on file, BIOTRONIK AG.
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Degradación en tiempo real
BIOlute se degraga gentilmente en 2 años para evital inflamación
In vitro degradation of BIOlute, real-time data
Time (days)
Mo
lecu
lar w
eig
ht
[a.u
.]
0.0
0.5
1.0
1.5
2.0
2.5
3.0
3.5
4.0
0 50 100 150 200 250 300 350 400 450 500
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12-Month Histology
Appearance of different morphology; however, analysis shows that there is no residual PLLA
Similar to the other absorbable platforms, there is only a morphometric imprint left
Polymer coating visible at one year
BIOlute muestra beneficios a nivel histológico vascular.
Mínima respuesta inflamatoria en tejido vascular
24-Month Histology 36-Month Histology
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PK Energy Características Que se traducen en “performance”
La plataforma de Pro-kinetic Energy ofrece una navegabilidad ecepcional y adecuada conformabilidad
Podemos esperar las características de Pro-kinetic en orsiro.
El diseño del stnet permite integridad del recubrimiento incluso a la máxima expansión del stent
Diseño de doble hélice que le confiere excelente flexibilidad sin fatiga de la resistencia o la fuerza radial.
La aleación cromo-cobalto permite struts mas delgados que resularan en mejoría en la navegabilidad.
La tecnología de montaje del stent permite mejor perfil de cruce (0.99 mm)
Sistema de entrega òptimo basado en la plataforma Pantera.
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En comparación tenemos uno de los menores grosores de strut para un DES
140 μm Strut thickness
Polymer thickness*
Total thickness
SEM images
Orsiro Hybrid DES
91 μm 81 μm 60 μm
12.6 μm
153 μm
4.8 μm
99 μm
7.8 μm
95 μm
7.4 μm
71 μm
*Only abluminal coating thickness represented
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La estrategia clínica de Orsiro va enfocada a recolectar los datos clínicos necesariospara compararlo a corto y largo plazo
Study design
A prospective, multi-centre, single treatment clinical trial
Endpoint: LLL 9 months, N=30
A prospective, multi-center, non-inferiority, randomized study, Orsiro vs. Xience Prime
Endpoint: LLL at 9 months, N=400+
A prospective, multi-centre, single treatment clinical registry
Endpoint: LLL at 9 months, N=100
A prospective, multi-centre, single treatment clinical registry
Endpoint: MACE at 9 months, with long term follow-up, N=1500+
To prove non-inferiority to the market leader DES
Pivotal Trial for market approval in India
Data can be pooled with other trials
Post marketing surveillance required from notified body
Study long term outcomes
FIM study, results used by TÜV in the CE-mark approval process.
Clinical strategy
Study design
Clinical strategy
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Bioflow I
Angiographic follow-up results
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Bioflow I
Cumulative Frequency of In-Stent Late Lumen Loss
Mean In-Stent LLL: 4 Months 0.12 ± 0.21 9 Months 0.05 ± 0.22
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Bioflow I
IVUS results
Mean net volume obstruction:
0.00% @ 4 months
0.07% @ 9 months
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Bioflow I
Clinical outcomes at 9 months
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Orsiro Specifications
Stent Material Cobalt Chromium, L-605
Passive Coating PROBIO® amorphous silicon carbide coating
Active Coating
BIOlute® High molecular weight Poly-L-Lactic Acid (PLLA) eluting sirolimus
Drug dose 1.4 μg/mm2
Strut Thickness 2.25-3.0 mm 71 µm/0.0030"
3.5-4.0 mm 91 µm/0.0031"
Foreshortening Minimal
Stent/artery ratio 11-18%
Crimped profile 0.99 mm / 0.039”
Catheter type Rapid exchange
Balloon material Semi crystalline polymer
Coating (distal shaft) Hydrophilic coating
Guiding catheter size 5F (min. I.D. 0.056")
Usable catheter length 140 cm
Nominal pressure 8 atm
Rated Burst Pressure 2.25-4.0 mm 16 atm
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Pressure (atm) Stent inner diameter (mm)
2.25 2.5 2.75 3.0 3.5 4.0
6 2.19 2.43 2.68 2.92 3.40 3.89
7 2.22 2.47 2.71 2.96 3.45 3.95
8 (NP) 2.25 2.50 2.75 3.00 3.50 4.00
9 2.28 2.53 2.79 3.04 3.55 4.05
10 2.31 2.57 2.82 3.08 3.6 4.11
11 2.34 2.60 2.84 3.12 3.64 4.16
12 2.37 2.64 2.9 3.16 3.69 4.22
13 2.40 2.67 2.94 3.20 3.74 4.27
14 2.43 2.70 2.97 3.25 3.79 4.33
15 2.46 2.74 3.01 3.29 3.83 4.38
16 (RBP) 2.50 2.77 3.05 3.33 3.88 4.44
17 2.53 2.81 3.09 3.37 3.93 4.49
18 2.56 2.84 3.12 3.41 3.98 4.55
19 2.59 2.87 3.16 3.45 4.02 4.60
Compliance Chart
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We are… … a USD >1 billion global cardiovascular leader thanks to 4 years as the fastest growing CRM & VI company
… pioneers of the paradigm shifting innovations of CLS, Fractal Coating, Home Monitoring, and DX
… steadfastly committed to providing high quality solutions and clinical excellence
… a highly professional, passionate, and motivated team who truly believes in 'excellence for life'
Orsiro… …Ofrece una nueva estrategia de tratar las arterias
coronarias sustentada en nueva tecnología (Probio y Biolute) garantizando máxima difusión de fármaco y mínima inflamación vascular.
…Entrega un fármaco con evidencia médica robusta y suficiente como es el sirolimus.
…Confiere excelente navegabilidad y perfil de cruce basados en la plataforma del Prokinetic.
…Ha demostrado evidencia contundente en términos de eficacia y seguridad tanto en puntos angiográficos como en puntos duros clínicos.
Introducing Orsiro, the world’s first hybrid drug eluting stent with biodegradable polymer
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Muchas Gracias!!!!!!!