MiRus Successfully Launches Early Feasibility Study of Siegel™ TAVR Heart Valve

MiRus Siegel™ TAVR Early Feasibility Study Highlights



In a groundbreaking development in cardiovascular health, MiRus has launched the Early Feasibility Study (EFS) for the Siegel™ 8-Fr aortic transcatheter heart valve (THV). Conducted across multiple centers in the U.S., this study aims to evaluate the safety and effectiveness of the Siegel device.

This week marked a significant milestone as the first two procedures using the Siegel valve were successfully completed by distinguished specialists Pradeep K. Yadav MD and Vinod H. Thourani MD at the Piedmont Heart Institute in Atlanta. The patients underwent the procedure without complications and were discharged the following day, an outcome indicating the valve’s potential efficacy in real-world clinical settings.

Innovations in Design and Functionality


The Siegel valve is noteworthy for several reasons. Its 8 French delivery sheath allows for less invasive procedures, which broadens patient accessibility, especially benefiting women and other demographics who might be underserved by traditional TAVR options. Unlike many contemporary THVs, the Siegel valve is also unique as the only nickel-free option on the market, catering to the estimated 20% of the American population with nickel allergies.

Another significant design advantage is its precise delivery mechanism. Thanks to its lack of foreshortening and maintained commissural alignment, doctors can position the valve with greater accuracy. Moreover, the device utilizes durable dry porcine pericardial leaflets that undergo anti-calcification treatment, enhancing longevity and performance.

Positive Initial Feedback from Physicians


Dr. Yadav expressed enthusiasm about the early results, noting that the Siegel device is considerably less invasive than existing alternatives. The precise placement facilitated by its innovative design may lead to lower rates of complications, such as the need for pacemaker implantation. He remarked on the excellent hemodynamic performance enabled by the valve's radial strength and material composition, which minimizes recoil and improves durability.

His colleague, Dr. Thourani, also shared his excitement about the Siegel valve’s inaugural cases.

Topics Health)

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