ATLANTA, April 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.
The STAR Trial (Siegel Transcatheter Aortic valve Replacement Trial), will evaluate the safety and effectiveness of the Siegel™ heart valve (THV) in patients with severe, symptomatic aortic stenosis who are considered low, intermediate or high risk for surgical complications. The combination of low delivery system profile and excellent hemodynamics seen with the Siegel THV is made feasible by the unique properties of the nickel-free Rhenium alloys pioneered by MiRus including high yield strength, fatigue resistance and minimal recoil.
“The initiation of this trial marks a critical step toward improving the treatment options for patients with aortic stenosis,” said Pradeep K. Yadav, MD, National Co-Principal Investigator STAR Trial, “As TAVR has becomes standard of care across risk profiles, it is vital that we study the next generation of devices and techniques to minimize risks such as stroke, bleeding, pacemaker dependency and optimize valve longevity – especially in younger, lower-risk patients.”
“Our initial experience is very positive,” commented Pradeep K. Yadav, MD. “Siegel is much less invasive then current devices and can be placed very precisely due to the lack of foreshortening. This should lead to lower pacemaker rates. The hemodynamics are excellent due to the radial strength and porcine pericardial leaflets.”
The STAR Trial Chairpersons are Martin Leon MD and Vinod Thourani MD. The National Principal Investigators are Pradeep Yadav MD, Raj Makkar MD, Samir Kapadia MD, and Philippe Genereux MD. STAR will enroll 1025 patients across multiple centers in the US. Patients will be randomized 1:1 to receive either the Siegel THV or a commercially available balloon or self-expanding THV. The primary endpoint of the study is a composite of mortality, stroke, and cardiovascular hospitalization at 1 year.
“In these first cases, the Siegel valve performance is impressive,” stated Vinod H. Thourani MD, National Co-Chairman STAR Trial and Marcus Chairman of Cardiovascular Surgery and the Marcus Valve Center, Piedmont Heart Institute. “An 8 French system with such precise placement, low gradients, and no PVL is a combination I never expected in THV. A THV without nickel is also much needed. The STAR trial is the most exciting trial in the management of aortic stenosis in the last decade!”
About Aortic Stenosis and TAVR
Aortic stenosis is a condition where the heart’s aortic valve becomes narrowed and stiff, obstructing blood flow, which can lead to severe heart failure and death if untreated.
Aortic stenosis affects millions of elderly people worldwide. TAVR is a minimally invasive procedure that allows a new valve to be inserted through a catheter, usually through a small incision in the groin, avoiding the need for a chest-opening surgery.
About MiRus, LLC.
MiRus is a life sciences company headquartered in Marietta, Georgia that has developed and is commercializing proprietary novel biomaterials, implants and procedural solutions for the treatment of spine, orthopaedic and structural heart disease. Inspired by the pioneering material science of NASA for rocket engines, MiRus has created Rhenium based medical alloys that are transforming medicine by making surgeries less invasive and implants safer and more durable. Find out more information about MiRus at www.mirusmed.com.
Statements made in this press release that look forward in time or that express beliefs, expectations or hopes regarding future occurrences or anticipated outcomes are forward-looking statements. A number of risks and uncertainties such as risks associated with product development and commercialization efforts, expected timing or results of any clinical trials, ultimate clinical outcome and perceived or actual advantages of the Company’s products, market and physician acceptance of the products, intellectual property protection, and competitive offerings could cause actual events to adversely differ from the expectations indicated in these forward looking statements. The Siegel TAVR system is an investigational device and not FDA approved.
* MiRus® , Siegel™ are all trademarks of MiRus, LLC.
For Immediate Release
Contact:
Pam Cowart
VP of Clinical Affairs
pcowart@mirusmed.com
770-861-4804
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SOURCE MiRus
