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In this paper we describe our coronary stent (INC-1) design and development, the way that we found the specific characteristics needed for our device including biophysics aspects, design, finite element testing, manufacturing and mechanic trials we submitted and animal models experiences. The stent platform was cobalt-chromium L605 (Co-Cr), with struts thickness of 80 µm, balloon expandable. We placed the coronary stent INC-1 on a rabbit and dog models so we can evaluate efficacy and security of the device in relationship to its biomechanical properties including navigation capacity, traceability, symmetric expansion and safety. As well as endothelial attachment, thrombogenicity and lack of involvement of secondary branches in these models. We succeeded in efficacy and safety of the device after fluoroscopy-guided implant proving excellent capacity of release system, traceability, fluoroscopic visualization, symmetric expansion and complete endothelial attach. Also, we obtained a good post-implant balloon withdrawal, functional integrity and no vascular complications. We observed adequate clinical evolution 3 weeks after the stent implantation.

Diseño y fabricación del stent coronario INC-1 y pruebas iniciales en animales de experimentación