This week, Medtronic (NYSE:MDT) unveiled recent clinical data reinforcing the efficacy of its Evolut Pro/Pro+ transcatheter aortic valve replacement (TAVR) system. The data showcased outcomes from the cusp overlap technique (COT) within the Optimize PRO clinical study, alongside a compiled analysis indicating a reduction in paravalvular leak (PVL) among Evolut Pro users over time post-hospital discharge. Researchers revealed these findings at the PCR London Valves 2024 conference.
A specific analysis focused on the decrease in PVL severity over time after using Evolut Pro in patients affected by severe symptomatic aortic stenosis (SSAS). This involved reviewing core lab echocardiographic data from 620 individuals treated with Evolut Pro across various studies. The analysis exhibited marked improvements in PVL levels from 30 days post-discharge, extending up to a three-year follow-up.
The Optimize PRO global study’s 30-day insights revealed that adhering to the COT with Evolut Pro and Pro+ devices resulted in improved procedural and clinical results. Conducted across 50 international centers, this multi-center, prospectively designed post-market study highlighted low occurrences of new 30-day permanent pacemaker implants (6.4% with COT adherence compared to 11.1% overall). Furthermore, there were no moderate or severe instances of aortic regurgitation at discharge.
Medtronic noted that these findings arise amidst a growing demand for TAVR, as medical professionals are in search of fresh clinical understandings to enhance the management of symptomatic severe aortic stenosis. This is particularly relevant for improving procedural and clinical outcomes and addressing common complications like PVL.