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Abstract
<p class="first" id="P1">Biodegradable magnesium (Mg) alloy stents are the most promising
next generation of
bio-absorbable stents. In this article, we summarized the progresses on the
<i>in vitro</i> studies, animal testing and clinical trials of biodegradable Mg alloy
stents in the
past decades. These exciting findings led us to propose the importance of the concept
“bio-adaption” between the Mg alloy stent and the local tissue microenvironment after
implantation. The healing responses of stented blood vessel can be generally described
in three overlapping phases: inflammation, granulation and remodeling. The ideal bio-adaption
of the Mg alloy stent, once implanted into the blood vessel, needs to be a reasonable
function of the time and the space/dimension. First, a very slow degeneration of mechanical
support is expected in the initial four months in order to provide sufficient mechanical
support to the injured vessels. Although it is still arguable whether full mechanical
support in stented lesions is mandatory during the first four months after implantation,
it would certainly be a safety design parameter and a benchmark for regulatory evaluations
based on the fact that there is insufficient human
<i>in vivo</i> data available, especially the vessel wall mechanical properties during
the healing/remodeling
phase. Second, once the Mg alloy stent being degraded, the void space will be filled
by the regenerated blood vessel tissues. The degradation of the Mg alloy stent should
be 100% completed with no residues, and the degradation products (e.g., ions and hydrogen)
will be helpful for the tissue reconstruction of the blood vessel. Toward this target,
some future research perspectives are also discussed.
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