Vascular Intervention

Drug Eluting Stents

Orsiro

Orsiro Hybrid Drug Eluting Stent

Industry's first hybrid DES
Orsiro
An ideal combination of passive and active components

The Orsiro Hybrid Drug Eluting Stent brings the

optimal combination of effortless deliverability,
coupled with a hybrid coating for treating coronary
artery stenosis.

This unique concept opens a new generation of drug

eluting stents for improving patient outcomes.
 hybrid
drug eluting stent

Industry's first hybrid stent design

with passive and active components

PROBIO passive coating encapsulates

the stent and reduces interaction between
the metal stent and the surrounding tissue

BIOlute active coating consists of a limus drug

and a bioabsorbable polymer matrix which achieves
a controlled drug release

PRO-Kinetic Energy Stent System brings exceptional

deliverability for reaching complex lesions

unique
innovation
Hybrid
design
Controlled drug release
Immediately following implantation
the drug elution from BIOlute starts.
In vivo studies show complete drug
release in approximately 100 days.

Bioabsorption
The gentle break down of the
BIOlute polymer matrix into
CO2 and H2O causes minimal
tissue burden and avoids
inflammation.

Inert backbone
When the BIOlute coating
is gone only a PROBIO
sealed stent is left in the
arterial wall.
passive
protection
Sealed with a semi conductive barrier
Once the stent is introduced into the body, water can immediately interact with the
metal surface. PROBIO coating is a silicon carbide, semi conductive sealant, that
reduces the interaction between tissue or blood with the metallic surface of the stent.

In vivo studies have shown up to a 96 % reduction of allergenic metal ions when the stent
surface is coated with silicon carbide.1

25 000

20 000
Concentration in ng/l

15 000

Competitor A
10 000 cobalt nickel alloy

Competitior B
5 000 cobalt chromium alloy

PRO-Kinetic Energy
0 with PROBIO coating

Cobalt Nickel Tungsten Chromium

1
Data on file at BIOTRONIK.

Quick facts
BIOlute is based on a bioabsorbable high molecular weight
Poly-L-Lactide (PLLA). The absorbtion process starts with
a reduction of polymer chain lengths and ends up in
the production of CO2 and water following the Krebs cycle.
There is a long history of using PLLA in medical applications.
 active
effectiveness
Bioabsorption
The polymer matrix of BIOlute consists of Poly-L-Lactide (PLLA). This highly biocompatible
material is gently absorbed over time, keeping inflammatory response below a critical level
throughout the process.

Histopathological preclinical results,

inflammation score2
3.0
Inflammation Score

2.0
28 days
1.0 90 days
0.49 0.51 0.50
0.3 0.33 0.31 0.16 0.17
0.12 180 days
0.0
PRO-Kinetic Energy PRO-Kinetic Energy Orsiro with PROBIO
with PROBIO coating with PROBIO and and BIOlute coating
PLLA coating

2
Overstretched minipig coronary artery model. Number of vessels 88. Data on file at BIOTRONIK.

Optimal release kinetics In vivo drug release in pig coronaries3

The most proven class of drugs for use 100 Orsiro (n=10)

90
on DES is the limus family. BIOTRONIK 80
Percent drug released

has chosen to use this as the therapatic 70

60
component of BIOlute. 50

40

30
The elution kinetic of Orsiro was 20

designed to maximize luminal diameter. 10

0
In vivo studies show complete drug
0 20 40 60 80 100
release in approximately 100 days. Time (days)

3
Data on file at BIOTRONIK.
 arrive
with ease
New DES specific crimping
An advanced crimping technique
ensures a low crossing profile
and secure stent retention without
affecting the BIOlute coating.

Advanced stent delivery system

Expect exceptional deliverability
and optimal stent deployment
from the Orsiro delivery system,
based on our Pantera PTCA
balloon technology.

Rugged and biocompatible matrix surface

The BIOlute polymer is a thin circumferential
coating. It keeps the stent profile low and does
not stick to the underlying balloon material.

During expansion, the

BIOlute coating stays
intact. 500x magnification.
advanced
stent design
The Orsiro Hybrid DES uses our PRO-Kinetic Energy platform that offers
exceptional bending flexibility without compromising scaffolding or fatigue
resistance. This advanced stent design allows for expansion of the stent
without affecting the BIOlute coating.

Powerful cobalt chromium alloy Ultra thin strut design (60 m)

Our advanced alloy material allow
engineers to push the limits of
design with novel concepts for
thinner struts and lower crossing
profile without compromising other
aspects of the stent.
Struts of only 60 micron (0.0024")4
result in exceptional flexibly and
ensure minimal vessel wall injury,
leading to better patient outcomes.
4
3.0 mm stent.
Technical data

Stent
Balloon diameter (mm) 2.25 2.5 2.75 3.0 3.5 4.0
Stent material Cobalt chromium, L-605
Passive coating PROBIO amorphous silicon carbide coating
Active coating BIOlute bioabsorbable Poly-L-Lactide (PLLA) eluting a limus drug
Drug dose 1.4 g/mm2
Strut thickness5 60 m (0.0024") 80 m (0.0031")
Foreshortening6 0% -0.7 %
Recoil6 4.7 % 4.6 %
Stent/artery ratio 18 % 16 % 14 % 13 % 12 % 11 %

5
Without active coating
6
Based on reference sizes 3.0/13, 4.0/15

Delivery system
Catheter type Rapid exchange
Shaft/balloon material Semi Crystalline Polymer material
Coating (distal shaft) Hydrophilic coating
Marker bands Two swaged platinum-iridium markers
Guide wire diameter 0.014"
Recommended guide catheter 5F (min. I.D. 0.056")
Lesion entry profile 0.017"
Usable catheter length 140 cm
Proximal shaft diameter 2.0F
Distal shaft diameter 2.6F: 2.25 3.5 mm
2.8F: 4.0 mm
Nominal pressure (NP) 8 atm
Rated burst pressure (RBP) 16 atm

Specifications

Atraumatic tip EFT (Enhanced Force Transmission) shaft

PROBIO coating Shaft markers

Bioabsorbable BIOlute
coating eluting a limus drug
 new
generation

Compliance chart
Inflation 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
NP 8 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 3.60 4.11
11 2.34 2.60 2.86 3.12 3.64 4.16
12 2.37 2.64 2.90 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
RBP 16 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 -

NP: Nominal Pressure

RBP: Rated Burst Pressure
Product ordering information
Stent diameter (mm) Stent length (mm)

9 13 15 18 22 26 30
2.25 364469 364475 364481 364487 364499 364505 364511
2.5 364470 364476 364482 364488 364500 364506 364512
2.75 364471 364477 364483 364489 364501 364507 364513
3.0 364472 364478 364484 364490 364502 364508 364514
3.5 364473 364479 364485 364491 364503 364509 364515
4.0 364474 364480 364486 364492 364504 364510 364516
 Orsiro Hybrid Drug Eluting Stent
Industry's first hybrid DES

BIOTRONIK AG
Ackerstrasse 6
8180 Blach Switzerland
380085/C/303

BIOTRONIK AG Tel +41 (0)44 8645111

All rights reserved. Specifications Fax +41 (0)44 8645005
are subject to modification, revision info.vi@biotronik.com
and improvement. www.biotronik.com