MiRus Releases Positive Data from First-in-Human Siegel TAVR Study

The initial experience with the MiRus Siegel 8-FR aortic transcatheter heart valve (THV) was presented at the New York Valves conference by Pradeep K. Yadav MD, Director of Structural Interventions, Piedmont Heart Institute, Atlanta.
 
Five patients with severe, symptomatic aortic stenosis were treated at the Instituto Nacional Del Torax in Santiago, Chile by Drs. C. Dauvergne, J. Sandoval, and P. Yadav. Three patients had bicuspid aortic valves and two were tri-leaflet valves. Three patients had peripheral arterial disease with vascular access under 5.5 mm.
 
No mortality or stroke was observed at 30 days with none requiring a permanent pacemaker or suffering from vascular complications. The mean echo gradient at 30 days was 6.7 mmHg. Four of five patients experienced no perivalvular leak (PVL) and one bicuspid patient had trace PVL, according to MiRus.
 
“The ease of use and hemodynamics were impressive,” commented Pradeep K. Yadav, MD.  “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.”
 
“This initial data is striking and potentially heralds a new age for TAVR,” added Vinod H. Thourani MD, Marcus Chairman of Cardiovascular Surgery and the Marcus Valve Center, Piedmont Heart Institute.  “The ability to treat such complex patients with an 8 French system and without Nickel exposure should make TAVR safer and more broadly accessible.  From a surgical viewpoint, the very low pressure gradients and low PVL are critically important to implanters and our patients.  We are truly on the precipice of surgical-like outcomes with the Siegel THV!!”

More about the Siegel valve

The valve features several firsts in TAVR.
 
It has an 8 Fr delivery sheath for less invasive procedures and broader patient access, particularly for women. It’s also the only nickel-free THV to treat the 20% of Americans that suffer from nickel allergies. Siegel’s dry porcine pericardial leaflets have anti-calcification treatment and the valve is pre-mounted on the balloon.
 
MiRus pioneered the unique properties of rhenium alloys, which creates high yield strength, fatigue resistance, and minimal recoil.