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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.
Financial & competing interests disclosure
Dr Mullen was Chief Investigator for the BEST study and has received payments for consultancy and teaching from NMT Medical. Carol Devellian is an employee and shareholder of NMT Medical. Dr Jux has received payment for teaching (clinical proctoring) from NMT Medical. His preclinical work reviewed in this article was funded in part by the German Federal Ministry of Education and Research (BMBF No. 03N4023) and NMT Medical. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
No writing assistance was utilized in the production of this manuscript.