Atlanta, Ga. (May 14, 2025) – Piedmont Heart Institute physicians Vinod H. Thourani, M.D., Marcus Chairman of Cardiovascular Surgery, and Pradeep K. Yadav, M.D., Director of Structural Interventions, treated a patient with severe nickel allergy with a novel nickel-free Siegel™ 8-French aortic transcatheter heart valve (THV) as part of an early feasibility study.
Last month (April 2025), Dr. Yadav and Dr. Thourani also did the first implants in the United States of the Siegel valve and launched their Early Feasibility Study.
Transcatheter aortic valve replacement, or TAVR, is a minimally-invasive procedure to replace the aortic valve in patients who suffer from severe aortic stenosis, a thickening and stiffening of the aortic valve that reduces blood flow to the body. The currently available devices contain nickel and their use is cautioned in patients with nickel allergy, which is quite frequent (up to 20%) in the United States. The Siegel device created by MiRus, a Marietta-based company, uses a novel Rhenium based alloy, which has superior biocompatibility and is nickel-free.
Early feasibility studies are limited clinical investigations of a device early in development that typically enroll a small number of subjects and are used to evaluate the device design concept with respect to initial clinical safety and device functionality, according to the U.S. Food and Drug Administration.
“Our initial experience is exceptional,” Dr. Yadav said. “Siegel brings many upgrades, such as small access, commissural alignment and a new stent design that does not change length during deployment, allowing us to place it very precisely every single time. This should lead to lower pacemaker rates.”
Said Dr. Thourani: “In these early cases, the Siegel valve performance is impressive. The 8 French system with such precise placement and low gradients and no paravalvular leak is not a combination I ever expected in a transcatheter heart valve. A transcatheter heart valve without nickel is also much needed.”
Piedmont Heart Institute, which treats patients from all 50 states, is a national destination for clinical care. Piedmont Heart clinicians are leading clinical trials, publishing frequently in the world’s leading medical journals and presenting at scientific sessions worldwide. Piedmont is one of the nation’s top enrolling centers in studies that include valvular heart disease, complex coronary intervention, renal denervation and beyond.