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since the introduction of drug-eluting stents (Des), physicians have
tried to find a delicate balance between achieving a highly effective
result without compromising the safety of the patient. Various
concepts have been introduced into the marketplace in the attempt to
identify the optimal combination of characteristics; however, until
now very little attention has been paid to combining a temporary drug
therapy with passivation of the metallic stent that is left in the
coronary artery. The orsiro Des (Biotronik Ag, Bülach, switzerland) is
the first hybrid Des, offering a unique hybrid coating consisting of
passive and active components. The ProBio passive coating
encapsulates the stent and eliminates interaction between the metal
stent and the surrounding tissue.
The Biolute active component is a bioabsorbable polymer matrix
combined with a -limus drug that is released in a controlled manner,
leaving only the ProBio-coated stent in the long term. The hybrid
solution with the ProBio and Biolute coatings is delivered using the
underlying Pro-Kinetic energy stent system with its thin strut design.
This combination of effortless deliverability with a hybrid structure
opens up a new generation of devices for improved
patient outcomes.
PROBIO Passive Coating
The ProBio passive coating
1
seals the stent surface and greatly
reduces interaction between the metal stent and the surrounding
tissue and blood by acting as a diffusion barrier (see
Figure 1
). This
thin-layer, amorphous silicon carbide coating is deposited onto the
surface of the stent through a plasma-enhanced chemical vapour
deposition technique.
2
This process covalently bonds the inert coating
to the metallic surface.
surface passivation aims to improve the biocompatibility of the
material by reducing thrombogenicity and encouraging re-
endothelialisation. The ProBio coating achieves this passivation
through its semi-conductive properties by reducing the interactions of
protein/cell constituents with the stent surface. Lower diffusion of
ions also leads to a lower rate of corrosion and a lower risk of tissue
inflammation response as a result of allergic reactions. in vitro studies
have shown up to a 96 % reduction of allergenic metal ion release
when the stent surface is coated with silicon carbide.1,2 ProBio
is well known as it has been used for more than 15 years on all
BioTroniK-manufactured stents and has been implanted in more
than one million patients.
in the short term the passive ProBio coating is covered by the active
absorbable polymer coating, but nevertheless ProBio serves a
purpose since ion release can take place through the degrading
polymer. After the active polymer coating has been absorbed, ProBio
keeps the stent surface sealed indefinitely and thereby minimises the
risk of late adverse events.
BIOlute Active Coating
The Biolute polymer base is made of poly-L-lactide (PLLA), a
well-characterised bioabsorbable polymer that has been approved for
medical use in a multitude of applications since the 1960s. The
selection of this polymer was made after thorough screening of
various polymer materials, both permanent and biodegradable. There
are four essential requirements for a carrier polymer:
3
• biocompatibility;
• controlled release of the drug;
Abstract
The orsiro device is a hybrid drug-eluting stent that represents a new strategy in the treatment of coronary artery stenosis. orsiro
features a hybrid coating of passive and active components: the ProBio passive coating seals the metal surface of the stent and prevents
interaction with the surrounding blood and tissue, while the Biolute active coating contains a highly biocompatible polymer that delivers
a -limus drug over 12–14 weeks and degrades gently over one to two years, thereby avoiding increased inflammation. The stent backbone
is the Pro-Kinetic energy platform, which has a double-helix stent design and thin struts, bringing flexibility and ease of deliverability.
Keywords
orsiro, hybrid, drug-eluting stent, coronary artery stenosis, ProBio passive coating, Biolute active coating, Pro-Kinetic energy platform
Disclosure:
The authors are employees of Biotronik.
Received:
8 July 2011
Accepted:
21 July 2011
Citation:
Interventional Cardiology
, 2011;6(2):142–4
Correspondence:
Michael Tittelbach, senior Director r&D combination Products, BioTroniK, switzerland. e: michael.tittelbach@biotronik.com
Support:
The publication of this article was funded by BioTroniK.
Orsiro – The First Hybrid Drug-eluting Stent, Opening Up a New Class of
Drug-eluting Stents for Superior Patient Outcomes
Mi chae l T i t te l bach
1
and Tob i as Di ener
2
1. Programme Manager for Combination Products, BIOTRONIK; 2. Head, Product Development Team, Drug-eluting Stents, BIOTRONIK
3
© T o u c h B r i e f i n g s 2 0 1 1
Drug-eluting Stents