Electroformed pure iron as a new biomaterial for degradable stents: in vitro degradation and preliminary cell viability studies.

In the search for a metallic material showing moderate and uniform degradation for application as degradable cardiovascular stents, electroformed iron (E-Fe) was evaluated by in vitro degradation and cell viability tests. Static immersion and dynamic degradation were used to evaluate degradation rate and mechanism, while cell viability assay was used to assess cytotoxicity. The results were compared with those of iron fabricated by casting and thermomechanical treatment previously investigated as a stent material. Electroformed iron showed faster degradation than iron fabricated by casting (0.25 vs. 0.14 mm year(-1)), with a uniform degradation mechanism. Cell viability results showed that E-Fe did not result in a decrease in metabolic activity when exposed to primary rat smooth muscle cells. However, it caused a decrease in cell proliferation activity which could be beneficial for the inhibition of in-stent restenosis.

Electroformed iron as new biomaterial for degradable stents: development process and structure-properties relationship.

An electroforming technique was developed for fabricating iron foils targeted for application as biodegradable cardiovascular stent material. The microstructure, mechanical properties and corrosion of electroformed iron (E-Fe) foils were evaluated and compared with those of pure iron made by casting and thermomechanical treatment (CTT-Fe), with 316L stainless steel (316L SS) and with other candidate metallic materials for biodegradable stents. Electron backscattered diffraction revealed an average grain size of 4 microm for E-Fe, resulting in a high yield (360 MPa) and ultimate tensile strength (423 MPa) being superior to those of other metallic biodegradable stent materials. Annealing at 550 degrees C was found to improve the ductility of the E-Fe from 8% to 18%. The corrosion rate of E-Fe in Hanks' solution, measured by potentiodynamic polarization, was higher than that of CTT-Fe, which had been found to have a slow in vivo degradation. The results showed that E-Fe possesses fine-grain microstructure, suitable mechanical properties and moderate corrosion rate as a degradable stent material.