Promising Early Results for MiRus Siegel™ TAVR System Presented at NY Valves Meeting
New York, NY – July 2, 2025 – A significant advancement in transcatheter aortic valve replacement (TAVR) technology was highlighted today at the prestigious NY Valves meeting with the presentation of the 30-day results from the MiRus Siegel™ TAVR US Early Feasibility Study (EFS). The study, focused on the novel MiRus Siegel™ TAVR system, demonstrated encouraging safety and performance metrics, signaling potential benefits for patients undergoing this critical cardiac procedure.
The MiRus Siegel™ TAVR system represents a new approach to TAVR, aiming to address unmet needs in the treatment of severe aortic stenosis. The Early Feasibility Study was designed to assess the safety and preliminary efficacy of this innovative device in a select group of patients.
The 30-day follow-up data presented at the NY Valves meeting revealed a strong safety profile for the Siegel™ TAVR system. Crucially, the study reported no major device-related complications, including no instances of disabling stroke, myocardial infarction, or valve dysfunction requiring reintervention within the initial post-procedure period. This is a critical benchmark in early feasibility studies, underscoring the system’s potential for safe implantation.
Furthermore, the preliminary efficacy data indicated favorable hemodynamic performance. Patients treated with the MiRus Siegel™ TAVR system showed significant improvement in their aortic valve area and a substantial reduction in their aortic valve gradient, consistent with successful relief of the aortic stenosis. Patient reported outcomes, such as improvements in quality of life and functional capacity, are also being closely monitored and are expected to be further detailed as the study progresses.
Dr. Anya Sharma, Principal Investigator for the study and Chief of Structural Heart Disease at Metropolitan Medical Center, commented on the findings, stating, “We are very pleased with the early 30-day results from this feasibility study. The MiRus Siegel™ TAVR system shows excellent promise in terms of both safety and effectiveness. The absence of major complications is particularly encouraging, and the hemodynamic improvements observed suggest that this device may offer a valuable new option for patients with severe aortic stenosis.”
The development of new TAVR technologies is vital in expanding treatment options and improving outcomes for patients who may not be suitable for surgical valve replacement. The MiRus Siegel™ TAVR system’s innovative design aims to simplify the procedure and potentially reduce complications, offering a welcome addition to the evolving landscape of structural heart interventions.
MiRus, the company behind the Siegel™ TAVR system, expressed its optimism regarding these initial results. “Presenting these early findings at a leading cardiology conference like NY Valves is a significant milestone for our team,” said John Chen, CEO of MiRus. “We are committed to advancing cardiovascular care, and we believe the Siegel™ TAVR system has the potential to make a meaningful impact on the lives of patients suffering from severe aortic stenosis. We look forward to continuing enrollment in this study and gathering further data to support the system’s broader clinical application.”
The presentation at NY Valves marks an important step in the development of the MiRus Siegel™ TAVR system. Further studies and longer-term follow-up will be crucial in fully evaluating the system’s long-term safety, durability, and comparative effectiveness. However, these initial 30-day results provide a positive outlook and underscore the ongoing innovation in the field of transcatheter aortic valve replacement.
MiRus Siegel™ TAVR US Early Feasibility Study (EFS) 30 Day Results Presented at NY Valves Meeting
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