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active
effectiveness
Biocompatible degradation
One component of the BIOlute
®
coating is a Poly-L-Lactic Acid (PLLA), as the base
polymer material. This highly biocompatible material gentle degrades over time,
keeping inflammatory response below a critical level throughout the process.
Inflammation Score
0.0
1.0
0.3 0.33
0.12
0.31
0.49
0.16
PRO-Kinetic Energy
with PROBIO
®
coating
PRO-Kinetic Energy
with PROBIO
®
and
PLLA coating
2.0
3.0
0.17
0.51 0.50
Orsiro with PROBIO
®
and BIOlute
®
coating
28 days
90 days
180 days
Histopathological preclinical results,
inflammation score
2
Optimal release kinetics
From all drugs, sirolimus is the
most proven therapeutic and
BIOTRONIK has chosen this drug
to be one component of BIOlute
®
.
The elution kinetic of Orsiro was
designed to maximize luminal
diameter. In vivo studies show that
drug is eluted over 12 - 14 weeks.
In vivo pharmacokinetic, residual drug on stent after explantation
Time (days)
100
0
10
20
30
40
50
60
70
80
90
Percent drug released
0
20
40
60
80
100
2
Overstretched minipig coronary artery model. Number of vessels 88. Data on file at BIOTRONIK.
Orsiro (n=10)