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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:

The capability of the guidewire is designed to assist the collecting and processing of large amounts of data as well as for facilitating the data required for artificial intelligence decision-making systems Xenter has unveiled wireless guidewire for TAVR procedures. (Credit: Business Wire) US-based medical device technology company Xenter has introduced its investigational dual sensor guidewire for transcatheter aortic valve replacement (TAVR) procedures. Unveiled at the Transcatheter Cardiovascular Therapeutics (TCT) 2023 conference in San Francisco, California, the first-of-its-kind wireless guidewire is intended for collection of an extensive range of key real-time data points. These points, according to Xenter, serve as an aortic regurgitation measurement (xAR) and clinical decision support tool for considerably improving the prediction of para valvular leak (PVL) during the TAVR procedure. The capability of the guidewire is designed to assist in the collecting and processing of large amounts of data as well as for facilitating the data required for artificial intelligence (AI) decision-making systems. Xenter chairman and CEO Rich Linder said: “We built Xenter to enable Artificial Intelligence (AI) tools to be utilised with ease and accuracy using new smart/wireless medical devices that transmit real-time Physical Intelligence (PI) data. “Xenter is pioneering smart medical devices and a wireless ecosystem that eliminate the capital equipment and mobile carts that clutter hospitals throughout the world.” Linder further stated that Xenter is introducing the XMD cloud, which integrates with hospital electronic health records (EHRs) and facilitates AI-driven clinical decision support tools based on real-time PI data. According to Xenter, the goal of the guidewire is to help make more informed clinical decisions and enhance patient outcomes. In addition, the guidewire is designed to seamlessly operate within a proprietary wireless ecosystem in the cardiac catheterisation lab, thereby enhancing accessibility to real-time data and analysis. Mainline Healthcare in Philadelphia cardiovascular medicine system chief William Gray said: “TAVR SmartWire will enable the real-time measurement of aortic and left ventricular pressure information in a single workhorse device that can be used to develop a measurement of Aortic Regurgitation (AR). “We plan to clinically evaluate TAVR SmartWire and provide physicians with a real-time AR measurement called xAR.”

Revolutionizing Data Collection in Cardiology with Proprietary Wireless Ecosystem DRAPER, Utah--(BUSINESS WIRE)-- Xenter, Inc. (Xenter.io) announced the recent unveiling of its groundbreaking dual sensor investigational guidewire for TAVR procedures at the Transcatheter Cardiovascular Therapeutics (TCT) 2023 conference in San Francisco, CA. Xenter introduced the first-of-its-kind wireless guidewire designed for use during transcatheter aortic valve replacement (TAVR) procedures that aims to collect an extensive range of crucial real-time data points to serve as an aortic regurgitation measurement (xAR™) and clinical decision support tool, significantly enhancing the prediction of para valvular leak (PVL) during TAVR. This press release features multimedia. View the full release here: Xenter introduced at TCT the first-of-its-kind wireless guidewire designed for use during transcatheter aortic valve replacement (TAVR) procedures that aims to collect an extensive range of crucial real-time data points to serve as an aortic regurgitation measurement (xAR™) and clinical decision support tool, significantly enhancing the prediction of para valvular leak (PVL) during TAVR. (Photo: Business Wire) The guidewire's functionality is designed to allow for comprehensive data collection and analysis and facilitates data necessary for novel Artificial Intelligence (AI) decision making tools. The goal is to enable better-informed clinical decisions and improve patient outcomes. The guidewire is designed to operate seamlessly within a proprietary wireless ecosystem in the Cardiac Catheterization Lab making real-time data and analysis more accessible than ever. Rich Linder, Chairman/CEO of Xenter, founded Xenter to revolutionize the collection of Physical Intelligence™ (PI) data into actionable insights. “We built Xenter to enable Artificial Intelligence (AI) tools to be utilized with ease and accuracy using new smart/wireless medical devices that transmit real-time PI data. Xenter is pioneering “smart” medical devices and a wireless ecosystem that eliminate the capital equipment and mobile carts that clutter hospitals throughout the world.” Linder continued, “Xenter is launching the XMD™ cloud that interfaces with hospital EHRs and enables AI driven Clinical Decision Support Tools derived from real-time PI data.” “An excellent example of real-time PI data collection is the TAVR SmartWire”, stated William A. Gray, M.D., System Chief of Cardiovascular Medicine at Mainline Healthcare in Philadelphia, PA. Dr. Gray continued, “TAVR SmartWire will enable the real-time measurement of aortic and left ventricular pressure information in a single workhorse device that can be used to develop a measurement of Aortic Regurgitation (AR). We plan to clinically evaluate TAVR SmartWire and provide physicians with a real-time AR measurement called xAR™.” Martin B. Leon, M.D., Chairman Emeritus of the Cardiovascular Research Foundation in New York City, NY, and Professor of Medicine at Columbia University/New York Presbyterian Hospital and Global Study Chair for TAVR SmartWire stated, “From the beginning, we saw the need to innovate and engineer new solutions in cardiovascular medicine that can transform how information is collected during interventional procedures, including TAVR. I’m looking forward to seeing these innovative solutions make their way into clinical research and to demonstrate the clinical utility of xAR™ in transcatheter aortic valve replacement.” About Xenter Xenter, Inc. is a privately held company headquartered in Salt Lake City, Utah, that is focused on developing new wireless medical device technologies that provide real-time Physical Intelligence™ data. For more information about Xenter, visit Xenter.io. #InterventionalCardiology #DigitalHealth View source version on businesswire.com: Contacts Bryan Osborn: Bryan.Osborn@Xenter.io 435-773-1345 Mike Russell: Mike.Russell@Xenter.io 801-554-6080 Source: Xenter, Inc. Smart Multimedia Gallery Photo Xenter introduced at TCT the first-of-its-kind wireless guidewire designed for use during transcatheter aortic valve replacement (TAVR) procedures that aims to collect an extensive range of crucial real-time data points to serve as an aortic regurgitation measurement (xAR™) and clinical decision support tool, significantly enhancing the prediction of para valvular leak (PVL) during TAVR. (Photo: Business Wire) Logo View this news release and multimedia online at: