Two new randomized clinical trials of percutaneous patent foramen ovale (PFO) device closure have shown superiority of device closure over medical management for the prevention of recurrent stroke.
The AHA/ASA Clinical Practice Guidelines on stroke prevention published in 2014 changed the previous percutaneous PFO closure indications (2006, 2011) from class II to class III. This change occurred despite the 2012 publication of [...]
The RESPECT Trial (Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment) is a multicenter (62 USA, 7 Canada) prospective 1:1 randomization superiority trial of patients 18-60 years [...]
ICD 9 diagnostic coding (745.5) and CPT therapeutic coding (93580) for defects of the atrial septum have not differentiated between defects of the fossa ovalis including ostium secundum defects (ASD II and PFO), fenestrations, [...]
December 21, 2016 AMPLATZER™PFO Occluder PMA Approval The Amplatzer™ PFO Occluder device received Pre-Market Approval (PMA) by the US Food and Drug Administration on October 28, 2016 for the prevention of recurrent paradoxical embolic [...]