Medtronic (NYSE: MDT) shared new clinical data this week supporting its Evolut Pro/Pro+ Transcatheter Aortic Valve Replacement (TAVR) system.

The results include the Cusp Overlap Technique (COT) findings from the Optimize PRO clinical study, as well as a pooled analysis of Evolut Pro patients showing improvement in paravalvular leak (PVL) over time post-discharge. Researchers presented these new studies at PCR London Valves 2024.

A matched analysis examined the improvement in PVL over time in patients with severe symptomatic aortic stenosis (SSAS) following TAVR using the Evolut Pro. It analyzed core lab echocardiography data from 620 patients treated with the Evolut Pro across multiple studies. The analysis demonstrated an improvement in PVL severity from 30 days post-discharge to three years of follow-up.

The 30-day results of the Optimize PRO Global Study indicate that using COT with the Evolut Pro and Pro+ devices leads to more favorable procedural and clinical outcomes. This multicenter, post-market, prospective study was conducted across 50 centers globally. It demonstrated a lower new 30-day permanent pacemaker implantation rate (6.4% for COT compliance, 11.1% overall). Moderate or severe aortic regurgitation was not observed at discharge.

According to Medtronic, these studies are being conducted at a time of increasing demand for TAVR, as clinicians are seeking new clinical insights to treat symptomatic severe aortic stenosis, particularly in terms of surgical and clinical outcomes as well as common complications such as PVL.