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Orsiro
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
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.
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.
The most proven class of drugs for use 100 Orsiro (n=10)
90
on DES is the limus family. BIOTRONIK 80
Percent drug released
60
component of BIOlute. 50
40
30
The elution kinetic of Orsiro was 20
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.
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
Compliance chart
Inflation pressure (atm) Stent inner diameter (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