BioSTAR® bioabsorbable septal repair implant

Abstract

Thousands of patients have had congenital defects of their intra-atrial septa successfully closed via percutaneous techniques in the cardiac catheterization laboratory for hemodynamic correction, stroke, migraine and decompression illness. However, currently available closure technologies leave a permanent cardiac implant in a relatively young patient population. As the first device incorporating a bioabsorbable material for the treatment of structural heart disease, BioSTAR® is uniquely designed to remodel into native tissue following closure, providing a more natural method of defect repair. This paper reviews atrial morphology, with a focus on patent foramen ovale, indications both present and emerging, and the development of technologies that promote a healthy natural healing response, with a focus on the design, testing and clinical experience with BioSTAR.