Episode description
🎬 In a new eye-opening episode of MedTech Voices, Medical Director Sally Sennitt and VP Jaishankar Kutty, Ph.D. – a true expert on cardiac valves – explore the EU MDR expert panel feedback from a minimally invasive tricuspid valve.
🩺 The submitted data from a single-arm study with a short six-month follow up, was found to be insufficient and lacking in quality and quantity... and not supporting a benefit-risk profile.
You'll learn considerably more from watching (or listening to) the 10-minute clip, but a few points:
1️⃣ The device's benefit-risk profile was not considered positive, highlighting the need for an RCT (Randomized Controlled Trial) comparing it against guideline-led medical therapy. Also, a six-month follow up was deemed not good enough for a CE marking.
2️⃣ The PMCF (Post-Market Clinical Follow-up) plan was underwhelming and raised several concerns. The study design lacked clear endpoints and didn't provide enough insight into what constitutes acceptable reduction in TR.
3️⃣ Regulatory and clinical reasons led the expert panel to conclude that this device is not ready for the market.
This episode serves as a critical reminder for the entire MedTech community to be vigilant about the quality of submissions to notified bodies. We must ensure we uphold the highest standards, especially during this significant juncture for the EU MDR.