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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. Continue Reading MiRus Siegel™ TAVR 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, 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 SOURCE MiRus WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

This is the first 35mm size valve implantation giving those with large native aortic valves at high-risk a minimally invasive option - avoiding open heart surgery LONG BEACH, Calif., June 21, 2024 /PRNewswire/ -- Yesterday, MemorialCare Heart & Vascular Institute at Long Beach Medical Center was the first hospital in Southern California to implant a 35mm Abbott Titan Navitor Valve during a Transcatheter Aortic Valve Implantation (TAVI) procedure. The TAVI procedure is crucial for patients who have severe aortic stenosis and are at extreme risk for open-heart surgery. This offers a minimally invasive approach which shortens hospital stays, reduces risk of infection and lessens recovery time. Continue Reading Titan Navitor Valve Team from MemorialCare Heart and Vascular Institute at Long Beach Medical Center "We are very proud of Dr. Anthony Chyou and Dr. Ali Khoynezhad for leading us through this transformational time of our heart and vascular institute," says David Shavelle, M.D., FACC, chief of cardiology, MemorialCare Heart & Vascular Institute; medical director, adult cardiology & interventional lab, MemorialCare Heart & Vascular Institute at Long Beach Medical Center. "We have always taken pride in creating an environment where our patients are given personalized treatment. The Navitor Titan 35mm Valve allowed us to provide a minimally invasive treatment option to a high-risk patient with severe aortic stenosis." The Navitor valve is one of the newest heart valve devices approved by the U.S. Food and Drug Administration for TAVI, also known as Transcatheter Aortic Valve Replacement (TAVR). This device is different from other heart valve replacement valves on the market due to improved blood flow (hemodynamic) performance and ease of use. "The intuitive design of the Navitor TAVI System allows more patients who normally would not be viable candidates for a Transcatheter Aortic Valve Replacement procedure access to a valve replacement," says Optum partnering physician Anthony Chyou, M.D., who is also an interventional cardiologist at MemorialCare Heart & Vascular Institute at Long Beach Medical Center. "Patients with large native aortic valves and severe aortic stenosis valve disease may not have been able to receive treatment as prior TAVI valves were not large enough to accommodate their anatomy." Heart valve disease limits the ability of the heart to pump blood through the entire body. The Navitor TAVI System has been tested and shown to greatly improve the blood flow of patients with symptomatic severe aortic stenosis, helping their hearts resume to normal, healthy blood flow performance quickly. "MemorialCare is dedicated to state-of-the-art, patient-centric care to our community, and this 'first in the region' procedure is a testament to our continued commitment to excellent patient care," says Ali Khoynezhad, M.D., director, aortic and arrythmia surgery, MemorialCare Heart & Vascular Institute at Long Beach Medical Center. The Navitor TAVI System has been rigorously tested and proven to yield positive 30-day outcomes in patients with symptomatic severe aortic stenosis, including a 0% chance of moderate or severe paravalvular leak (PVL), 1.9% chance of all-cause mortality, 1.9% chance of disabling stroke, and 4.2% chance of major vascular complications, proving its remarkable safety and effectiveness in TAVR procedures. About MemorialCare Long Beach Medical Center: MemorialCare Long Beach Medical Center is a member of MemorialCare, a not-for-profit, integrated healthcare system. Long Beach Medical Center has been providing the community with compassionate, quality health care for more than 100 years. At the forefront of specialized care, research, and education, Long Beach Medical Center uses the most advanced healthcare technologies, including pioneering surgical systems like – ExactechGPS® and ExcelsiusGPS®. Recognized among the top 3% of all California acute care hospitals, Long Beach Medical Center is recognized as "Best Hospital" for OBGYN and Orthopedics and ranked regionally in the Los Angeles Metro Area by U.S. News & World Report and earned Magnet® recognition for nursing excellence. With premier centers dedicated to cancer, heart, rehabilitation, orthopedics, neurosciences, and trauma, physicians and surrounding hospitals continually refer to its accredited programs. For more information, visit memorialcare.org/LongBeach. SOURCE MemorialCare Long Beach Medical Center

WASHINGTON--(BUSINESS WIRE)-- Edwards Lifesciences (NYSE: EW) announced today at Cardiovascular Research Technologies (CRT) 2024 the compelling results from two large, real-world studies based on TVT Registry data that demonstrated continued excellent outcomes for patients treated with the Edwards SAPIEN valve platform. A study of Edwards’ latest TAVR technology, the SAPIEN 3 Ultra RESILIA valve, found lower rates of paravalvular leak (PVL) at 30 days, lower echo-derived gradients and larger effective orifice areas across all valve sizes when compared to the SAPIEN 3 and SAPIEN 3 Ultra valves. These data were presented yesterday during a podium presentation and simultaneously published in the Journal of the American College of Cardiology (JACC): Cardiovascular Interventions. In a second study presented during the late-breaking clinical trials session, small Edwards SAPIEN TAVR valves demonstrated equally excellent outcomes at 3 years as compared to larger SAPIEN TAVR valve sizes. “These real-world data further add to the robust body of evidence on the performance of Edwards SAPIEN TAVR and highlight the meaningful advancements of the SAPIEN 3 Ultra RESILIA valve, which provides patients with severe aortic stenosis the leading option for true lifetime management of their heart valve disease,” said Larry Wood, Edwards’ corporate vice president and group president, transcatheter aortic valve replacement and surgical structural heart. Real-World Results of the SAPIEN 3 Ultra RESILIA Valve In a study of real-world evidence of patients from the TVT Registry, researchers compared the outcomes of more than 10,000 patients across more than 800 sites in the United States treated with the SAPIEN 3 Ultra RESILIA valve to those receiving SAPIEN 3 Ultra and SAPIEN 3 valves using procedural and hemodynamic data and clinical outcomes for propensity-matched cohorts. The study found that all Edwards TAVR platforms demonstrated excellent PVL results. Notably, there was a statistically significant reduction in PVL for the 29 mm SAPIEN 3 Ultra RESILIA valve as compared to the 29 mm SAPIEN 3, with 88.3% of patients exhibiting no PVL and only 10.7% of patients exhibiting mild PVL. The SAPIEN 3 Ultra RESILIA valve was also associated with significantly lower echocardiography-derived mean gradients and larger effective orifice areas across all four valve sizes with low rates of all-cause mortality, cardiac death, all stroke, life-threatening bleeding, major vascular complications, and permanent pacemaker implantation in-hospital or at 30 days. Late-Breaking Clinical Results Comparing Small Edwards TAVR Valves to Larger Valves An analysis of 8,100 propensity matched patients across more than 800 sites in the United States found that patients treated with a 20mm Edwards SAPIEN valve demonstrated excellent all-cause mortality and stroke outcomes at 3-years, equivalent to those receiving 23, 26 and 29mm SAPIEN valve sizes. Among mortality indicators, researchers concluded that while PVL and new permanent pacemaker implantation were both associated with increased mortality, the relationship between post-procedural echo-derived mean gradients and clinical outcomes is nonlinear and more complex. “This examination of these real-world data gives us important insights into the actual performance of small Edwards valves and reaffirms the excellent outcomes for patients receiving SAPIEN TAVR, regardless of valve size,” said Amr Abbas, MD, Professor of Medicine at Oakland University William Beaumont School of Medicine, Director of Structural Heart at Corewell Health East, William Beaumont University Hospital and principal investigator in the small SAPIEN valve study. About Edwards Lifesciences Edwards Lifesciences is the global leader of patient-focused innovations for structural heart disease and critical care monitoring. We are driven by a passion for patients, dedicated to improving and enhancing lives through partnerships with clinicians and stakeholders across the global healthcare landscape. For more information, visit Edwards.com and follow us on Facebook, Instagram, LinkedIn, Twitter and YouTube. This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include, but are not limited to, statements made by Mr. Wood and statements regarding expected product benefits, patient outcomes, post-treatment reduction of invasive procedures, objectives and expectations and other statements that are not historical facts. Forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though they are inherently uncertain and difficult to predict. Our forward-looking statements speak only as of the date on which they are made, and we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement. Investors are cautioned not to unduly rely on such forward-looking statements. Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those expressed or implied by the forward-looking statements based on a number of factors as detailed in the company's filings with the Securities and Exchange Commission. These filings, along with important safety information about our products, may be found at Edwards.com. Edwards, Edwards Lifesciences, the stylized E logo, Edwards SAPIEN, Edwards SAPIEN 3, Edwards SAPIEN 3 Ultra, RESILIA, SAPIEN, SAPIEN 3, and SAPIEN 3 Ultra are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners. View source version on businesswire.com: Contacts Source: Edwards Lifesciences Corporation View this news release online at: