Latest news with #MiRus
Associated Press
02-07-2025
- Health
- Associated Press
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 Feasibility Study (EFS). In the US EFS, 15 patients with severe, symptomatic aortic stenosis (AS) were treated at Piedmont, Cedars Sinai, Stanford, Mayo Clinic and Naples. At 30 days, there were no deaths, strokes or re-hospitalizations. No patients had vascular complications, PVL (> moderate) or required a permanent pacemaker. Core lab echocardiographic data demonstrated a mean gradient of 6.3 mmHg, and valve area of 2.8 cm2 . The Siegel valve represents several firsts in TAVR: 8 French delivery sheath allowing less invasive procedures and broader patient access, particularly for women; the only Nickel-free THV allowing treatment of the 20% of Americans suffering from Nickel allergies; precise delivery due to lack of foreshortening and intrinsic commissural alignment; dry porcine pericardial leaflets with anti-calcification treatment and with the valve pre-mounted on the balloon. 'This is the first TAVR to have no foreshortening during implantation and along with small vascular access, makes it very user friendly and should also lead to fewer pacemakers and vascular complications' commented Pradeep K. Yadav, MD. 'The lack of nickel is also very appealing – we were able to treat a patient with severe nickel and cobalt allergy.' The combination of low delivery system profile and excellent hemodynamics is made feasible by the unique properties of the Rhenium alloys pioneered by MiRus including high yield strength, fatigue resistance and minimal recoil. 'The gradients and valve areas with the Siegel valve are outstanding' stated Raj R. Makkar, MD. 'Valve placement is very precise and allows us to protect the conduction system – one of our patients was quite elderly with pre-existing conduction system injury and we were able to replace his valve without having to place a permanent pacemaker.' 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 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. Contact: Pam Cowart VP of Clinical Affairs [email protected] 770-861-4804 View original content to download multimedia: SOURCE MiRus
Yahoo
28-03-2025
- Health
- Yahoo
MiRus Siegel™ TAVR: First EFS Cases
ATLANTA, March 28, 2025 /PRNewswire/ -- 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 Cardiovascular Surgery, Piedmont Heart Institute, Atlanta. Both patients were discharged without complications the next day. The Siegel valve represents several firsts in TAVR: 8 French delivery sheath allowing less invasive procedures and broader patient access, particularly for women; the only Nickel-free THV allowing treatment of the 20% of Americans suffering from Nickel allergies; precise delivery due to lack of foreshortening and intrinsic commissural alignment; dry porcine pericardial leaflets with anti-calcification treatment and with the valve pre-mounted on the balloon. "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 combination of low delivery system profile and excellent hemodynamics is made feasible by the unique properties of the Rhenium alloys pioneered by MiRus including high yield strength, fatigue resistance and minimal recoil. "In these first two cases, the Siegel valve performance is impressive," stated Vinod H. Thourani MD, Marcus Chairman of Cardiovascular Surgery and the Marcus Valve Center, Piedmont Heart Institute. "8 French system with such precise placement and low gradients and no PVL is not a combination I ever expected in THV. A THV without nickel is also much needed." About 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 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. Contact:Pam CowartVP of Clinical Affairspcowart@ 770-861-4804 View original content to download multimedia: SOURCE MiRus Sign in to access your portfolio
