Contemporary ASD Closure: A Review of FDA-Approved Devices and Patient-Specific Selection-The ASD Closure Module for Occlutech in the CRISP Registry, An Invitation to Participate, Dr Daisuke Kobayashi and Panel Discussion

The ASD Closure Module for Occlutech in the CRISP Registry, An Invitation to Participate, Dr Daisuke Kobayashi and Panel Discussion

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Video Transcription

Video Summary

The discussion centers on post-market surveillance of medical devices, highlighting the transition from tightly controlled pre-market trials to real-world applications. The Ocrotech ASD module, part of the CRISP registry, exemplifies this, aimed at collecting real-world data on the safety and effectiveness of the Ocrotech ASD device. Challenges such as the cost and limited generalizability of traditional studies are contrasted with the broader, more inclusive registry-based surveillance. Panelists share their experiences with various devices, discussing factors like the need for device flexibility, the implications of wire fractures, and residual shunt rates. The debate underscores the importance of balancing efficacy with potential risks, such as device erosion and mitral valve complications, especially in older patients. Emphasizing continuous learning and adaptation, the dialogue calls for registries to track data reliably and for the industry to respond proactively to safety concerns while considering surgical options when necessary.

Keywords

post-market surveillance

medical devices

real-world data

registry-based surveillance

device safety