Accepted to2way special stitches may be absorbed after wound healing is underway, the new generation of coronary stents will fulfill their role as vascular scaffolding
and then proceed to beabsorbed by the body. Quite stringent corrosion and mechanical benchmarks apply to anymaterials considered for use in an absorbable stent for reasons related to deployment, efficacy,and device safety. Specific design considerations that have been suggested in the scientificliterature are compiled in
. It is important to note that the research community has notyet reached a consensus on some criteria presented in this table. For example, there are atleast two different ideal grain size ranges proposed in the literature,
and there is stilldisagreement on the subject of aluminum as an allowable alloying addition.
General design constraints and criteria for a bioabsorbable metal stent
Criterion Constraints Ref.
BioabsorptionMechanical integrity for 3-6 monthsMechanical integrity for 4 monthsMechanical integrity for 6
12 monthsFull absorption in 12
BiocompatibilityNon-toxic, non-inflammatory, hypoallergenicNo harmful release or retention of particlesNo aluminum or zirconium content
MechanicalpropertiesYield strength > 200 MPaTensile strength > 300 MPaElongation to failure > 15
18%Elastic recoil on expansion < 4%
MicrostructureMaximum grain size of ~30
mMaximum grain size of 10
Evolution < 10 μL H
Penetration rate < 20 μm
Research spanning the last decade has focused on iron
and their alloys as bioabsorbable stent materials. Over the past two years, the authors have assessed the
corrosion behavior of iron and magnesium using a specialized, rat-based method of evaluation.
These analyses, in combination with characterization of samples corroded
have proven that iron is an unsuitable material for coronary stent application. Thecorrosion product not only reduces the cross sectional area of the lumen and compromises theintegrity of the arterial wall, but it appears to be stable in the physiological environment