A Novel Bioresorbable Septal Occluder

DESCRIPTION (provided by applicant): There is a significant body of evidence that links patent foramen ovale with cryptogenic stroke. Furthermore, closure of the patent foramen ovale has been shown to reduce the risk of stroke in high-risk patients. Closure of a patent foramen ovale is currently done by percutaneous device closure using a septal occluder. This procedure has become standard for very high-risk patients. Additionally, research on the merits of performing this procedure to lower-risk cryptogenic stroke patients is ongoing. While available septal occluders have been shown to be safe and effective, the foreign body material of the device remains in the body long after complete ingrowth of the occluding device by endogenous tissue has occurred. This foreign material leads to a number of adverse effects, such as perforations, erosions, and metal fatigue fractures, which have been known to occur well past the timeframe where the metallic framework is actually providing a necessary clinical function; NMT Medical, Inc. has designed a bioresorbable septal occluder to address this concern. This Phase I STTR project will demonstrate feasibility by implanting the devices in an ovine animal model with a created septal defect in a chronic study.