Key result
The Occlutech Figulla ASD Occluder demonstrated a similar reduction in the prevalence of residual shunt over time compared to the Amplatzer Septal Occluder (P = 0.68).
Why the study?
Does the Occlutech Figulla ASD Occluder provide similar efficacy and safety compared to the Amplatzer Septal Occluder for percutaneous closure of secundum atrial septal defects?
Observational (n=75)
Does the Occlutech Figulla ASD Occluder provide similar efficacy and safety compared to the Amplatzer Septal Occluder for percutaneous closure of secundum atrial septal defects?
p-value: p=0.68
The novel Figulla ASD Occluder is a safe and effective alternative to the Amplatzer Septal Occluder for transcatheter closure of secundum atrial septal defects, with similar rates of residual shunt and complications.
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Supports comparable residual shunt reduction with the Figulla occluder; leaves open confirmation of equivalence versus Amplatzer in randomized ASD trials.
Polat et al. (2009) conducted an observational in secundum atrial septal defects (n=75). Occlutech Figulla ASD Occluder (FSO) vs. Amplatzer Septal Occluder (ASO) was evaluated on reduction in prevalence of residual shunt with time (p=0.68). The Occlutech Figulla ASD Occluder demonstrated a similar reduction in the prevalence of residual shunt over time compared to the Amplatzer Septal Occluder (P = 0.68).
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