Episode description
🏥 In connection with the FDA’s recent approval of Edwards Lifesciences’ transcatheter tricuspid valve replacement device, here is some commentary from RQM+ Vice President of Intelligence & Innovation, Jaishankar Kutty, Ph.D., about the importance of the benefit-risk story within the target patient population under the aegis of the state of the art and standard of care, in justifying the quantity of clinical data.
Jai also discusses certain aspects of uncertainty that will face other followers in this technology space. Finally, there is time spent on some critical post-market areas that regulators could be focusing on for this device, and they they almost certainly will be focusing on for other devices to follow (perhaps in the pre-market phase). 📊
🕒 Timestamps if you'd like to jump ahead:
00:00 Introduction and Basis of Approval
03:22 Clinical Data and Outcomes
06:14 Regulatory Uncertainties for Device Manufacturers
10:33 Post-Market Areas of Focus for Regulators
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