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.

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Piedmont 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.