Xtrace: Novel Bioresorbable Device for Patent Foramen Ovale Closure

Sara Ajamieh, Diana Mindroc-Filimon, Irene Mozo, Isabel Rocha

Abstract

Patent foramen ovale (PFO) is a congenital cardiac lesion, affecting about 25% to 30% of the adult population. It is associated with several serious complications, including cryptogenic strokes, transient ischemic attacks, and migraine. The prevalence of PFO has significantly increased in patients with cryptogenic stroke; up to 40% of ischemic strokes with an unknown cause have a PFO. Recently, technical advancements in medical engineering have made the percutaneous transcatheter closure of PFO a feasible treatment option. However, current PFO closure devices may lead to complications such as the need for replacing the device after several years, sudden migration of the implant, erosion, infection, or arrhythmias. Attempts are needed to produce a safer and more effective closure devices. Here, we propose an innovative medical device called Xtrace. It consists of a biodegradable material that will be partially degraded by the host body while substituted by autologous host tissue. This innovative device will potentially fulfill the essential unmet clinical need, as well as provide a safe and effective delivery of therapy for the general population.

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