2. Introduction
In medicine, a stent is any device which is inserted
into a blood vessel or other internal duct in order to expand the
vessel to prevent or alleviate a blockage.
A bioresorbable, biodegradable, or bioabsorbable
stent serves the same purpose,
but is manufactured from a
material that may dissolve or be
absorbed in the body.
Bioabsorbable scaffolds have been
heralded as the fourth revolution
interventional cardiology----a novel
concept in the treatment of coronary
artery disease.
3. Introduction
Unique ability to permit the restoration of vascular physiology
and integrity as they provide a temporary scaffold.
That is necessary to maintain the patency of the vessel after
intervention, and then they gradually dissolve, liberating the
vessel from its cage.
Thus, it is expected that Bioabsorbable stents will potentially
overcome the limitations of the traditional stents, such as the
risk of late stent thrombosis, and the local inflammation caused
by the presence of a foreign body.
4. Material
Characteristic
s for Stents
The material for bioabsorbable stents is requested to
have at least the following characteristics:
It must be biocompatible.
Degradation products of the material must also be
biocompatible.
The material must stay in the place for several months before
its complete bioabsorption.
5. Bioabsorbable
Stent Design
The ideal design should have:
Mechanical properties
Must be biocompatible and would be made of biocompatible
Adequate degradation time,
have good deliverability.
Ideally, it should be able to carry an antiproliferative drug in
order to reduce restenosis.
6. Mechanism of
Absorption
Degradation of polymers generally refers to cleavage
of covalent bonds between repeating units. During this chemical
process, long backbones break into smaller oligomers (or
monomers) by hydrolysis, oxidation, and enzymatic mechanisms.
7. Types of
Stents
Regarding the material, there are two possibilities that
are being tested:
Polymer-based materials Among the polymers, the one
that has been used more frequently is Poly-L-lactic acid
(PLLA).
Absorbable metals such as magnesium-based alloys.
8. Bioabsorbable
Polymeric
Stents
They employ a wide variety of polymers, such as those made
from lactic acid, glycolic and caprolactone.
The most used polymer for is composed of poly-L-lactic acid
(PLLA). PLLA is already found in many medical items,
including dissolvable sutures and various implants, and itself has
a degradation time of 12-18 months.
Another polymer used is the polymer-tyrosine derived
polycarbonate and it primarily degrades into L-tyrosine.
9.
10. Dissolvable
Metallic Stents
The biodegradable or dissolvable metallic stents consist of
either magnesium-based (Mg) or iron-based (Fe) alloys.
These metals are alloyed with calcium (Ca), zinc (Zn) and
manganese (Mn) as they are well tolerated in the human body.
The alloying of Fe with other metals is necessary to alter its
ferromagnetism which can reduce MRI compatibility.
As for magnesium, it is alloyed to decrease its degradation rate
and increase its ductility and strength.
11. Magnesium based
Bioabsorbable Stent
• Mg has low
thrombogenicity + good
compatibility
• The first metallic
bioabsorbable stent
implanted in humans was
studied in the
PROGRESS-AMS trial
where 71 magnesium
stents, were implanted in
63 patients…no
thrombosis, heart attack
12. Iron based
Bioabsorbable
Stents
This stent is made of 41mg pure iron and was
implanted in New Zealand white rabbits into its
descending aorta.
The results from the implantation showed no significant
evidence of inflammatory response or neointimal (scar tissue
formation) proliferation.
Iron is also an interesting candidate……
Mechanical properties.
It has a high radial strength and high ductility because of its
higher elastic modulus.
Iron can interconvert between ferric (Fe2+) and ferrous (Fe3+)
,making it a useful component for cytochromes, oxygen-binding
molecules (hemoglobin and myoglobin), and many enzymes
13. Bioabsorbable
Coronary
Stents:
Current Status
& Clinical
Trials
Presently, 14 different bioabsorbable stents are in preclinical
and clinical testing worldwide.
As bioabsorbable stents receive FDA approval, the US will
acquire market share and steadily become the largest market
through 2018 and beyond.
Global Data estimates bioabsorbable stent sales to be US$4.2m
in 2012 across the US, France, Germany, Italy, Spain and the
UK, growing to over US$700m by the end of 2018.
14. Conclusion
Bioabsorbable Scaffold have been announced as the fourth
revolution in interventional cardiology, introduce
a new concept in the treatment of coronary artery
disease.
Since metallic stents provide better treatment but it is required to
last for 6–12 months. After this period, the presence of stent
within the body cannot provide any beneficial effects. Thus, the
development of bioabsorbable stents, which can fulfill the
mission and step away, is the logical approach.
The advantages of the BAS are manifold, with the most key being
that it provides no triggers for stent thrombosis.
Lastly, the use of this stent will allow a level of psychological
relief of concern to patients who dislike the idea of having a
foreign material in their bodies for the rest of their lives.
15. Put down the remote and go for walk…………
Thanks…..
Notas do Editor
Both the selection of the material and the design are going to influence the success of the device.
Mechanical properties----provide the necessary vessel support during the required period.
Must be biocompatible and would be made of biocompatible material to prevent vessel irritation, and should have an
Adequate degradation time,
disappearing without creating an intense inflammatory response.
have good deliverability.
Ideally, it should be able to carry an antiproliferative drug in order to reduce restenosis.
The majority of bioabsorbable materials have low radio-opacity, but the visualization of the device under fluoroscopy can be increased by the use of radio-opaque markers in the balloon or in the device itself
Degradation of polymers (fig.4) generally refers to cleavage of covalent bonds between repeating units. During this chemical process, long backbones break into smaller oligomers (or monomers) by hydrolysis, oxidation, and enzymatic mechanisms. The small oligomers are phagocytosed by macrophages and further metabolized to carbon dioxide and water by the human body. The polymerization byproducts (initiators, stabilizers, and catalysts) are also released into surrounding tissues, which may cause an adverse response. Increased toxicity due to elevated local concentrations of acid has been reported.
The degradation rate is accelerated as water accessibility into the polymer matrix becomes feasible. Water accessibility depends on the chemical structure (hydrophobicity of the polymer, molecular weight), dimension, morphology (crystallinity and porosity), and the local tissue environment.
These degradation products are natural metabolites and finally degrade to carbon dioxide and water via the Krebs cycle.
Rezolve….sirolimus or paclitaxel
IDEAL…….both properties anti proliferative anf inflammatory
DESolve….plla based polymer drug matrix
There were no deaths, myocardial infarctions, or stent thrombosis, and the stent was no longer.
Magnesium is another attractive metal for biodegradable implants because of its low thrombogenicity and well-known biocompatibility. It is an essential trace element and has a high systemic toxic level which is about 7 to 10 millimols per liter of serum [16]. The use of magnesium as a biodegradable stent material was also based on the fact that it is a structural constituent of the tissue and essential element in the living organism. Magnesium is a substantial intercellular cation which is involved in more than 300 biological reactions of cell. Magnesium is also regarded as a non-carcinogenic element [31]. However, magnesium has a rapid degradation in aggressive chloride environments like body fluid. Rapid degradation of magnesium implant results in tissue overload with degradation prTherefore, magnesium is alloyed with other elements such as aluminum, manganese and rare earth elements in order to decrease the degradation rate oducts and this can lead to neointimal formation
Iron can interconvert between ferric (Fe2+) and ferrous (Fe3+) ions by accepting and donating electrons quite readily, which makes it a useful component for cytochromes, oxygen-binding molecules (hemoglobin and myoglobin), and many enzymes
Since metallic stents provide better treatment but it is required to last for 6–12 months during which arterial remodeling and healing is achieved. After this period, the presence of stent within the body cannot provide any beneficial effects. Thus, the development of bioabsorbable stents, which can fulfill the mission and step away, is the logical approach