MiRus Siegel 8-F TAVR System Evaluated in Early Feasibility Study

July 2, 2025—MiRus, LLC, announced the presentation of 30-day results from the United States early feasibility study (EFS) of the company’s Siegel transcatheter aortic valve replacement (TAVR) system.

Pradeep K. Yadav, MD, and Raj R. Makkar, MD, presented the EFS findings and patient case studies at the New York Valves conference held June 24-26.

According to the company, the EFS included 15 patients with severe, symptomatic aortic stenosis treated at five centers in the United States. At 30 days, there were no deaths, strokes, or rehospitalizations. No patients had vascular complications or > moderate paravalvular aortic leak, and none required a permanent pacemaker. Core lab echocardiographic data demonstrated a mean gradient of 6.3 mm Hg and valve area of 2.8 cm², reported the company.

MiRus stated that the Siegel device is composed of rhenium alloys, which provide high yield strength, fatigue resistance, and minimal recoil and allow a low delivery profile with excellent hemodynamics.

The company further stated that the Siegel TAVR system’s 8-F delivery sheath allows for less invasive procedures and broader patient access, particularly for women; the nickel-free device allows for treatment of patients with nickel allergies, and a lack of foreshortening and intrinsic commissural alignment allows for precise delivery.

“This is the first TAVR to have no foreshortening during implantation, and along with small vascular access, makes it very user friendly and should also lead to fewer pacemakers and vascular complications,” commented Dr. Yadav in the company’s press release. “The lack of nickel is also very appealing—we were able to treat a patient with severe nickel and cobalt allergy.”

Dr. Makkar added, “The gradients and valve areas with the Siegel valve are outstanding. Valve placement is very precise and allows us to protect the conduction system—one of our patients was quite elderly with preexisting conduction system injury, and we were able to replace his valve without having to place a permanent pacemaker.”

In June 2024, MiRus announced that the first-in-human procedures with the Siegel 8-F TAVR device were performed at Instituto Nacional Del Torax in Santiago, Chile.