Medtronic has reported new clinical data from the study of its Evolut transcatheter aortic valve replacement (TAVR) system, which is anticipated to offer fresh insights for global implanters treating symptomatic severe aortic stenosis (SASS).
The company released the new data at PCR London Valves 2024.
Conducted across 50 global centres, the "Optimize PRO" clinical study has shown positive procedural and clinical outcomes when using the cusp overlap technique (COT) with the Evolut PRO and PRO+ devices.
It reported a low rate of new 30-day permanent pacemaker implantation at 6.4% with COT compliance and no moderate or severe aortic regurgitation at discharge.
Furthermore, the study assessed the performance of the valve and procedural outcomes associated with an "optimised" TAVR care pathway, leveraging COT for Evolut valve deployment.
This technique aims to assist implanters in achieving optimal implant depth to minimise the conduction system interaction.
At the 30-day mark, the primary endpoint of all-cause mortality or all stroke was reported at 5.1%, all-cause mortality at 0.8%, disabling stroke at 1.7%, and cardiovascular rehospitalisation at 5.7%.
In addition to the Optimize PRO study, a pooled analysis of patients treated with the Evolut PRO valve was presented.
This analysis showed improvement in paravalvular leak (PVL) rates over time post-TAVR. The study analysed core lab echocardiographic data from 620 subjects across various trials.
From the paired analysis, the PVL severity for 30 days after discharge from hospital was 60.8% none/trace, 36.0% mild, 0.3% severe and 2.9% moderate. The PVL severity improved to 79.8% none/trace, 19.6% mild, 0.6% moderate, and no severe cases at the three-year follow-up.
Medtronic structural heart and aortic business president and senior vice-president Nina Goodheart said: “With the Evolut TAVR system, we are committed to improving outcomes for patients while maintaining exceptional safety and efficiency.
“The data presented at London Valves 2024 further establishes Medtronic and Evolut as leaders in supporting and sharing the robust clinical evidence physicians need to make the best decisions for their patients when choosing and performing TAVR.”
The company recently received clearance from the US Food and Drug Administration for its new InPen app.
