Transvenous implantation of the Occlutech Atrial Flow Regulator: Preliminary results from swine models

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 PFO closed by day 28 and the other embolized on day 3. CONCLUSION: The Occlutech AFR has shown to be safe and easy to implant with good results [Krizanic et al. J Invasive Cardiol. 2010;22(4):182.]. This study has further shown that histologically the device does not cause any end organ damage, causes minimal inflammation, with almost no thrombus formation and can remain patent and secure in the atrial septum.