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Press Releases

MiRus Begins Patient Enrollment in the STAR Randomized Trial of the Siegel™ Transcatheter Aortic Valve

ATLANTA, Apr. 8, 2026 /PRNewswire/ — MiRus today announced successful enrollment and treatment of the first patients in the STAR Trial, a prospective, multicenter, randomized controlled trial studying the Siegel™ 8-Fr aortic transcatheter heart valve (THV). The first procedures were performed at Piedmont Heart Institute by Pradeep K. Yadav, MD, Director of Structural Interventions, and Vinod H. Thourani, MD, Marcus Chairman of Cardiovascular Surgery. …

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MiRus® Receives FDA 510(k) Clearance for IO™ Expandable Wedge Osteotomy System

ATLANTA, Feb. 23, 2026 /PRNewswire/ — MiRus® today announced FDA 510(k) clearance and commercial launch of the IO™ Expandable Wedge Osteotomy System, an innovative solution designed to bring intraoperative precision and adjustability to foot and ankle osteotomy procedures. Powered by MiRus’ proprietary MoRe® Superalloy and the MoRe Expansion Engine, the IO™  Expandable Wedge Osteotomy system introduces controlled, incremental expandability to Evans osteotomies, …

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Unconditional FDA Approval of the STAR Trial (Siegel Transcatheter Aortic Valve Replacement in patients with symptomatic severe aortic stenosis)

11/25/2025 MiRus receives unconditional FDA approval for the STAR Trial RCT of the Siegel TAVR.
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MiRus Receives New Technology Add-on Payment (NTAP) for EUROPA™ Posterior Cervical Fusion System

Atlanta – August 1, 2025 – MiRus has received New Technology Add-on Payment (NTAP) from the Centers for Medicare and Medicaid Services (CMS) for the EUROPA® Posterior Cervical System, based on it’s proprietary rhenium alloys, for treatment of the cervical and upper thoracic spine.  The EUROPA® PCF system is built around a 2.9 mm MoRe …

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MiRus Siegel™ TAVR US Early Feasibility Study (EFS) 30 Day Results Presented at NY Valves Meeting

ATLANTA – July 2, 2025 /PRNewswire/ – The MiRus Siegel™ Valve was featured in three podium presentations at the NY Valves meeting last week. Pradeep K. Yadav MD, Piedmont Heart Institute, Atlanta and Raj R. Makkar MD, Cedars Sinai Heart Institute, Los Angeles presented patient case studies and the 30 day results of US Early …

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MiRus Siegel™ TAVR: First EFS Cases

Atlanta – March 28, 2025 – MiRus is pleased to announce the launch of the US multi-center Early Feasibility Study of the Siegel™ 8-Fr aortic transcatheter heart valve (THV). The first two cases were successfully performed this week by Pradeep K. Yadav MD, Director of Structural Interventions, and Vinod H. Thourani MD, Marcus Chairman of …

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MiRus Receives Breakthrough Device Designation for Spine Implant

Atlanta – July 31, 2024 – MiRus has received Breakthrough Device Designation from the FDA for the EUROPA® Posterior Cervical System, based on it’s proprietary rhenium alloys, for treatment of the cervical and upper thoracic spine.  The EUROPA® PCF system is built around a 2.9 mm MoRe rod which is much smaller than current commercial …

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MiRus Siegel™ TAVR: First in Human Results Presented at New York Valves

New York – June 6, 2024 – Pradeep K. Yadav MD, Director of Structural Interventions, Piedmont Heart Institute, Atlanta presented the initial experience with the MiRus Siegel™ 8-Fr aortic transcatheter heart valve (THV) at the New York Valves conference. Five sequential patients with severe, symptomatic aortic stenosis (AS) were treated at the Instituto Nacional Del …

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MiRus® Announces FDA 510(k) Clearance for Molybdenum-Rhenium (MoRe®) Low Profile Anterior Cervical and Lateral Lumbar Plating Systems

ATLANTA — October 18, 2023 — MiRus® announced that it has received FDA 510(k) clearance of the CYGNUS™ MoRe® Anterior Cervical Plate and MiRus® 3DR™ Lateral Lumbar Interbody Fusion System with Integrated MoRe® plate fixation, both being the narrowest and thinnest plating system amongst all plates on the global spine market. MoRe®, a proprietary molybdenum …

MiRus® Announces FDA 510(k) Clearance for Molybdenum-Rhenium (MoRe®) Low Profile Anterior Cervical and Lateral Lumbar Plating Systems Read More »

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MiRus® Announces Launch of Molybdenum-Rhenium Low Profile ATLAS™ MoRe® Foot and Ankle Plating System

ATLANTA — September  18, 2023— MiRus announces limited market release in the U.S. of its  ATLAS™ MoRe® Foot and Ankle Plating System, the thinnest  foot and ankle plate on the market for treatment of foot and ankle conditions. The molybdenum-rhenium alloy used in the plates allows for a dramatically smaller footprint of 1.0mm thickness without …

MiRus® Announces Launch of Molybdenum-Rhenium Low Profile ATLAS™ MoRe® Foot and Ankle Plating System Read More »

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