MiRus announced positive results from the first in-human trials of its MiRus Siegel transcatheter aortic heart valve (TAVR).
The trial, involving five patients with severe symptomatic aortic stenosis, showed no mortality or stroke at 30 days, and none of the patients required a permanent pacemaker or experienced vascular complications.
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It was conducted at the Instituto Nacional Del Torax in Santiago, Chile, where patients with both bicuspid and tri-leaflet aortic valves were treated.
Notably, three of the patients also had peripheral arterial disease, presenting challenges for vascular access.
Despite these complexities, the post-procedure outcomes were positive, with a mean echo gradient of 6.7mmHg recorded at 30 days. Additionally, four patients exhibited no peri-valvular leak, while one bicuspid patient had a trace amount.
Said to be the only nickel-free TAVR system on the market, the Siegel TAVR system utilises an 8 French delivery sheath to enable lesser invasive procedures and increased accessibility for a broader patient demographic, including women.
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By GlobalDataPiedmont Heart Institute Atlanta structural interventions director Dr Pradeep K Yadav presented the initial experience with the MiRus Siegel THV at the New York Valves conference.
Yadav said: “On the very first case, we comfortably achieved a deployment with 90% aortic and 10% ventricular positioning.
“The lack of foreshortening is very helpful in precise deployment every time, a feature that implanters will love. Also, the frame strength and virtually no recoil allows cylindrical valve expansion with no waist even in complex bicuspid patients, which contributes to excellent hemodynamics and hopefully durability.”
Additionally, the valve features dry porcine pericardial leaflets treated with an anti-calcification process and comes pre-mounted on the balloon.
The combination of a low delivery system and superior haemodynamics is credited to the rhenium alloys developed by MiRus.
These alloys boast high yield strength, fatigue resistance, and minimal recoil, which are critical for the performance and durability of the valve.
