Episode description
🎬 In our latest MedTech Voices clip, RQM+ VP of Intelligence and Innovation Jaishankar Kutty, Ph.D. and Medical Director Sally Sennitt delve into the EU MDR expert panel feedback about a groundbreaking minimally invasive tricuspid valve.
Why watch? 🤔
1️⃣ Gain a comprehensive understanding of the intricate balance between benefit and risk as the clip explores the imperative of a Randomized Controlled Trial (RCT) for precise evaluation against guideline-driven medical therapy. The significance of an extended follow-up period is also underscored.
2️⃣ Navigate Post-Market Clinical Follow-up (PMCF) planning, as Sally and Jai dissect the study design's nuances, delineate the pursuit of well-defined endpoints, and scrutinize the determination of acceptable reduction in TR.
3️⃣ Uncover the convergence of regulatory and clinical considerations that ultimately led the expert panel to their decisive determination regarding the device's market readiness.
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