Atrial Septum defect occurs when the separating wall between heart chambers does not develop properly allowing communication and mixing of the oxygen-rich blood with the oxygen-poor blood supplying blood with lower oxygen levels to the rest of the body. A similar condition called Patent Ductus Arteriosus that results in blood contamination between the descending thoracic aorta and the pulmonary artery. Both conditions can be currently treated with medical devices that attempt to create a blockage between the chambers or vessels. However, current devices available are expensive and public health institutes are not able to treat their patients with them. The National Institute of Cardiology Ignacio Chávez wanted a low-cost solution to be able to treat all of its patients. Together with company GSE Biomedical we worked on the solution to make it accessible to the population.


We designed an occlusion device along with its low-cost manufacturing process without sacrificing performance of the implant. We worked on checking different geometries of the implant, utilizing finite element analysis to verify that the new occlusion implant developed in Mexico complied with the requirements established by the group of clinical advisors and could be manufactured at a low cost.


The final iteration was selected validating the configuration of the opening process through computer simulation and by evaluating the accumulated stresses and the plastic behavior of the device once it reached the final “bell-shaped” geometry for better attachment to the vessel walls.



“Bioana team, you guys are simply amazing. Thanks so much for all your team’s hard work on this. We remain impressed beyond measure.”

Mark Lee

CEO, Ocumetics

"Our experience with Bioana had been outstanding. Their commitment, eye for detail, punctuality, proactivity and understanding manufacturing principles, workflow, quality and resourcefulness has been beyond our expectations."

Frank Harder

CRO , Bolb Inc.

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