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Contemporary ASD Closure: A Review of FDA-Approved ...
Occlutech ASD Occluder: Device Characteristics and ...
Occlutech ASD Occluder: Device Characteristics and Technical Nuances of Delivery and Deployment, Dr. Gurumurthy Hiremath
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Video Transcription
Video Summary
The presentation introduced the Occlutec ASD Occluder, highlighting its evolution since its inception in 2003. Initially lacking an LA hub, it has undergone significant improvements, notably with the FigulaFlex mechanisms, allowing for better flexibility and alignment during implantation. The device received U.S. FDA approval in December 2023, identical to the FigulaFlex II used internationally. Key features include being a double-disc nitinol device with self-centering capabilities and immediate occlusion PET patches. The Occlutec system provides user-friendly deployment, minimizing risks like bleeding. Comparison studies, such as the Kenyattal, show it as non-inferior to the Amplatzer, with higher first-attempt success rates and favorable safety/efficacy outcomes. The meta-analysis highlights less fluoroscopic time and arrhythmias in comparison to its competitors. Despite potential erosion risks similar to those of the Amplatzer, the Occlutec ASD Occluder is considered a valuable tool requiring careful implantation practices to mitigate oversizing risks.
Keywords
Occlutec ASD Occluder
FigulaFlex mechanisms
FDA approval
self-centering device
implantation safety
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