Kamel Shibbani¹, Daniel McLennan², Dunbar Ivy³, Gareth Morgan^3,*

Congenital Heart Disease, Vol.17, No.3, pp. 269-280, 2022, DOI:10.32604/chd.2022.019973

Abstract Objective: The Atrial Flow Regulator (AFR) is a double disc device made of self-expanding Nitinol wire mesh, structured around a central lumen. Once deployed via the transfemoral route, the device stents the atrial septum leaving a preselected fixed diameter atrial communication. We sought to evaluate the mid-term performance of the AFR by implanting the device in 5 healthy porcine hearts to assess safety and patency of the device fenestration over a period of 150 days. Method: Five AFR devices were implanted in 5 female Yucatan adult minipigs. The animals were survived to 150 days with periodic assessments at days +3,… More > Graphic Abstract

Daniel McLennan, Dunbar Ivy, Gareth J. Morgan

Congenital Heart Disease, Vol.14, No.5, pp. 819-831, 2019, DOI:10.1111/chd.12816

Abstract Aims: To evaluate in domestic pigs the histopathological processes after implanting the Occlutech Atrial Flow Regulator (AFR).
Methods and Results: Eleven pigs were chosen and had successful implantation of the AFR. Five pigs were sacrificed at 28 days, and 5 pigs at 90 days. One pig was sacrificed at day 3 after device embolization. Each pig had echocardiography performed at 3 weeks to check patency. Post mortem evaluation included Gross evaluation, radiographic evaluation, histology, and electron microscopy. Nine of the 10 devices implanted remained patent at time of autopsy with no thrombus and minimal inflammation. One device placed in the… More >