Medtronic Plc

In December, Edwards Lifesciences persuaded CMS to publish an updated tracking sheet for TAVR national coverage analysis, causing the agency to reconsider its previous stance on covering transcatheter aortic valve replacements for Medicare beneficiaries. The public comment period, which ran from December 15 to January 14, drew more than 150 responses on CMS’ website , and was more controversial than many medtech groups expected. In the 44-page letter written to CMS, Edwards asked CMS to expand the indication to include asymptomatic patients, sunset the coverage with evidence development requirements, and remove barriers to access related to pre-procedural, peri-procedural and infrastructure requirements, stating that the updated TAVR NCD could help improve efficiency in existing centers. According to a survey conducted by analysts at BTIG, 44% of surveyed U.S. physicians believe that there would be a meaningful uptick in TAVR patients if these changes were made, citing reasons such as 'easier to schedule without a surgeon,' and '...would streamline logistics and reduce procedural scheduling barriers.' While Edwards’ request for Medicare to cover TAVR in asymptomatic patients has received support from several medical groups, many physicians are cautioning against it, saying more research is still needed. In addition, Edwards competitor Medtronic is also speaking out against potential CMS coverage. In May, Edwards won a nod from FDA to approve the Sapien 3 platform, a transcatheter aortic valve replacement therapy to treat patients without symptoms, suffering from severe aortic stenosis. This was the first time FDA approved TAVR for asymptomatic patients. The Sapien 3 platform (Sapien 3, Sapien 3 Ultra, and Sapien 3 Ultra Resilia) has been approved based on data from the EARLY TAVR trial, which demonstrated that asymptomatic severe AS patients randomized to Edwards TAVR experienced superior outcomes compared to guideline-recommended clinical surveillance (watchful waiting). In April, the company secured a CE mark for the Sapien M3 mitral valve. The approval was for the transcatheter treatment of patients with symptomatic (moderate-to-severe or severe) mitral regurgitation (MR) who are deemed unsuitable for surgery or transcatheter edge-to-edge (TEER) therapy. In 2024, Edwards won a nod from FDA for another groundbreaking technology: the company’s Evoque Transcatheter Tricuspid Valve Replacement technology. In the CMS public comments, several physicians challenged Edwards’ Early TAVR clinical trial, which showed asymptomatic patients had better outcomes after having the procedure than those in a group that remained under clinical surveillance. “While emerging trial data suggests potential benefit in select patients, treatment should be limited to carefully defined populations evaluated by a multidisciplinary Heart Team, with shared decision-making and continued evidence development to avoid inappropriate expansion and overtreatment,” Joseph Sabik, president of the Society of Thoracic Surgeons, wrote to CMS. “The ability to diagnose asymptomatic aortic stenosis and existing clinical guidelines are not yet mature enough for CMS to use for coverage without additional evidence development,” Jeff Farkas, Medtronic VP, wrote. “While evidence is emerging on TAVR as a treatment option for the asymptomatic aortic stenosis population, we caution that long-term outcomes will be important to establish and monitor for these patients.” “Given the problems with the study design, CMS should be reluctant to make a coverage decision that would encourage Medicare asymptomatic beneficiaries to earlier lifelong device implantation, potential re-interventions, and downstream complications without clear evidence of survival or disability benefit,” Diana Zuckerman, president of the nonprofit National Center for Health Research, noted, arguing that early TAVR trial data do not justify broad national coverage, as they cannot be generalized to most Medicare beneficiaries because study patients were largely labeled as “low risk” for surgery. Several major medical groups, including the University of Pennsylvania, Columbia University, UCSF, also wrote in opposition to the update. “On behalf of the University of Pennsylvania Transcatheter Aortic Valve Replacement (TAVR) Program, we write to express strong concern regarding CMS’s consideration of removing the requirement that both a cardiac surgeon and an interventional cardiologist be involved in TAVR procedures. The Heart Team model is the foundation of safe and effective TAVR. It is not a formality. It is the clinical and safety architecture that allowed TAVR to move from experimental therapy to standard of care…TAVR carries the risk of catastrophic events including annular rupture, coronary obstruction, valve embolization, and cardiac or vascular perforation — situations that require immediate surgical decision-making and intervention. No protocol, remote consultation, or transfer agreement can substitute for a surgeon who is physically present and fully integrated into the procedural team,” a spokesperson for the university wrote. Mulero Portela, MD, director of cardiovascular surgery at Mayaguez Medical Center, also noted that he believes many pro-TAVR studies on asymptomatic patients may be based in biased research. “I am a cardiac surgeon and in short the answer is “no”, TAVR is not the solution for all. The real problem is that the trans-aortic valve replacement - TAVR (which is a misnomer, since the native valve is crushed and left in place, not replaced, and it should be called trans-aortic valve implantation - TAVI) is a fast growing business backed by the marketing of the manufacturing companies without having unbiased studies, it has no multiple or multi-center randomized clinical trials and no enough unbiased scientific data to support its indications in many cases. In the real world nowadays the so-called TARV is a one man show - the gatekeeper is diagnosing, grading and managing the aortic stenosis (AS) with no questioning and very little discussion of the benefits, risks, alternatives and consequences with the patients. There is a lot of data, publicly undisclosed and available only to the inquisitive mind, that clearly shows its inferiority to the surgical alternative, the surgical aortic valve replacement (SAVR), including the high percentage of patient-prosthesis mismatch (PPM) and the low durability of the implanted valve with the TAVR due to its accelerated deterioration due to the severe trauma caused to the valve during the implantation thru the small caliber catheters, ballooning and the persistence of the sick calcified native valve, drawbacks that are all avoided during the SAVR,” he wrote. “In my opinion, releasing the called TAVR for all asymptomatic patients with severe AS without revising the actual guidelines and indications by an unbiased committee, without having a serious independent analysis of the TAVR registry, and without having strong scientific evidence of benefits vs risks, is going to increase healthcare costs, may harm people with the wrong diagnosis and wrong timing, and it is going to increase hospital costs and mortality of the aortic valve surgery so badly that it may even disappear or has to be performed at very few super-subspecialized cardiovascular centers.” On the other hand, five major medical societies issued comments in favor of CMS expansion, including The Society of Thoracic Surgeons, the American Association for Thoracic Surgery, American College of Cardiology, Heart Failure Society of America, and Society for Cardiovascular Angiography and Interventions, though the societies do recommend changes to the existing framework of the proposal. Now that arguments have been made on both sides of the aisle, it’s time for TAVR supporters and opposers alike to sit in wait, A proposed decision memo is due June 15, 2026 and the final NCD is expected by September 13, 2026.

Jan. 22, 2026 -- Anteris Technologies Global Corp. (Anteris or the Company) (NASDAQ: AVR, ASX: AVR) a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function, announced today it has completed a $90 million strategic investment from Medtronic, plc (Galway, Ireland) (NASDAQ: MDT) (Medtronic), the world’s largest medical technology company. The investment closed immediately following Anteris’ underwritten offering of common stock, for a combined $320 million in gross proceeds, which supports execution of the global pivotal PARADIGM trial and advances the Company toward global commercialization of the DurAVR® Transcatheter Heart Valve (THV). Anteris and Medtronic are aligned around the belief that reshaping the Transcatheter Aortic Valve Replacement (TAVR) market requires advancing clinical science and valve design while maintaining rigorous standards for durability, hemodynamics, and long‑term patient outcomes. “This strategic investment, along with our underwritten offering of common stock, represent an important milestone for our company. It also provides strong validation of our program from the capital markets and a major strategic innovator,” said Wayne Paterson, Anteris Vice Chairman and CEO. “The investment is one aspect of a collaboration that may expand into other strategic areas in the future. Anteris has developed a clinically important, evidence-supported product designed to improve the lives of patients with aortic stenosis as we advance toward regulatory approval.” “The Board is excited to welcome Medtronic to its stockholder community,” said John Seaberg, Chairman of the Anteris Board. “This investment aligns two organizations in their commitment to advancing valve science in a way that is disciplined and focused on long‑term patient benefit.” “Medtronic is a pioneer in TAVR innovation and evidence,” said Jorie Soskin, Vice President and General Manager of the Structural Heart business in Medtronic’s Cardiovascular portfolio. “Our investment in differentiated innovation like the DurAVR® THV technology — which has the potential to offer improved valve performance in a balloon-expandable platform — is core to our commitment to define and drive the future of TAVR, meeting the needs of more aortic stenosis patients and heart teams with a comprehensive portfolio." The Medtronic investment and the underwritten public offering of common stock position Anteris to continue to execute the global PARADIGM Trial and to continue investing in research that can transform the treatment of aortic stenosis. Wells Fargo Securities acted as sole placement agent in connection with the Medtronic investment. The PARADIGM Trial is a prospective randomized controlled trial (RCT) which will evaluate the safety and effectiveness of the DurAVR® THV compared to commercially available transcatheter aortic valve replacements (TAVRs). This head-to-head study will enroll approximately 1000 patients in the ‘All Comers Randomized Cohort' with 1:1 randomization of patients who will receive either the DurAVR® THV or TAVR using commercially available and approved THVs. The PARADIGM Trial will assess non-inferiority on a primary composite endpoint of all-cause mortality, all stroke and cardiovascular hospitalization at one year post procedure. The PARADIGM Trial has commenced recruitment with the first patients enrolled and implanted during the fourth quarter of 2025. Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) is a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function. Founded in Australia, with a significant presence in Minneapolis, USA, Anteris is a science-driven company with an experienced team of multidisciplinary professionals delivering restorative solutions to structural heart disease patients. Anteris' lead product, the DurAVR® Transcatheter Heart Valve (THV), was designed in partnership with the world's leading interventional cardiologists and cardiac surgeons to treat aortic stenosis – a potentially life-threatening condition resulting from the narrowing of the aortic valve. The balloon-expandable DurAVR® THV is the first biomimetic valve, which is shaped to mimic the performance of a healthy human aortic valve and aims to replicate normal aortic blood flow. DurAVR®THV is made using a single piece of molded ADAPT® tissue, Anteris' patented anti-calcification tissue technology. ADAPT® tissue, which is FDA-cleared, has been used clinically for over 10 years and distributed for use in over 55,000 patients worldwide. The DurAVR® THV System is comprised of the DurAVR® valve, the ADAPT® tissue, and the balloon-expandable ComASUR® Delivery System. The content above comes from the network. if any infringement, please contact us to modify.

First-of-its-kind, rotation-free single-shot PFA catheter supported by strong safety and efficacy data adds to the groundbreaking Affera family of technologies in EuropeSuccessful completion of first cases at multiple sites kicks off Horizon 360 IDE pivotal trial in the United States GALWAY, Ireland, Jan. 23, 2026 /PRNewswire/ -- Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced two major milestones for the Affera™ Sphere-360™ catheter, a first-of-its-kind, all-in-one mapping and single-shot pulsed field ablation (PFA) catheter for treatment of paroxysmal atrial fibrillation (AFib): CE Mark in Europe and the completion of first cases in the Horizon 360 IDE pivotal trial in the United States. Continue Reading Sphere-360™ pulsed field ablation catheter Affera™ mapping and ablation system The Sphere-360 catheter was designed in response to physician feedback expressing the need for a simple, differentiated workflow and predictable outcomes using a single catheter that accommodates anatomical variations in pulmonary veins. Seamlessly integrated with the Affera mapping and ablation system, the catheter offers an adjustable configuration lattice design that conforms to the shape of the veins and allows energy delivery without the need to rotate the catheter in each position. The Affera mapping and ablation system and the Sphere-9™ all-in-one mapping and ablation catheter have been rapidly adopted by physicians in multiple geographies for their excellent safety and durability profile. "The Sphere-360 catheter offers an excellent balance between ease of use and consistency in outcomes. Its design conforms to the pulmonary vein in a unique way that delivers consistent, effective and durable lesions for AFib patients, without any rotation of the catheter," said Tobias Reichlin, M.D., Director of Electrophysiology at Inselspital University Hospital in Bern, Switzerland. "With the full integration into the Affera mapping system, it's an exciting step forward for patient care in Europe." Additional benefits of Sphere-360 include: Delivers circumferential, consistent lesions from the entire 34 mm lattice without catheter rotation, enhancing workflow efficiency Adapts to the vein by adjusting the shape of the conformable lattice to the patient's anatomy All-in-one catheter for navigation, mapping, and ablation with a single transseptal puncture and zero catheter exchange Real-time local impedance information to assess catheter proximity to tissue Easy access to pulmonary veins with enhanced stability through its over-the-wire design Compatible with FlexCath Contour™ 10 French deflectable sheath designed for easy catheter positioning "Advances in electrophysiology over the past several years are having a significant impact on care for arrhythmia patients, and Affera has been a key part of that impact," said Vivek Reddy, M.D., Director of Cardiac Arrhythmia Services for the Mount Sinai Health System in New York City. "Now with Sphere-360, we have a new and differentiated single-shot PFA catheter with the potential to deliver the next phase of innovation. It's an exciting time for physicians and patients and we're not slowing down." Results from the Sphere-360 European study at one year were presented at the Heart Rhythm Society Annual Meeting and published in the Heart Rhythm Journal in April 2025. The prospective, single-arm, multi-center trial in European centers demonstrated excellent efficacy, safety, and durability that led to CE Mark. "The achievement of CE Mark for Sphere-360, as well as the first cases in the U.S. IDE trial, mark two major achievements in our effort to deliver new and better treatments to AFib patients," said Rebecca Seidel, president of the Cardiac Ablation Solutions business, which is part of the Cardiovascular Portfolio. "We're committed to leading in PFA and bringing meaningful innovation at a regular cadence." The Horizon 360 IDE study is a prospective, single-arm clinical study at centers across the U.S. The study will evaluate the safety and effectiveness of the Sphere-360 catheter with the Affera mapping and ablation system for treating paroxysmal AFib. About Medtronic PFA Medtronic was the first company with two PFA offerings for physicians and patients. The PulseSelect™ Pulsed Field Ablation System offers physicians a safe, single-shot solution for pulmonary vein isolation (PVI) and is now available in more than 35 countries. Sphere-9™ is the only all-in-one, dual energy mapping and ablation catheter for treatment of persistent AFib and concomitant CTI-dependent atrial flutter. The Affera system, together with the Sphere-9 catheter, enables physician treatment flexibility with its wide area focal design and 9mm lattice tip that can be used with an 8.5Fr sheath. Affera is approved in the U.S., Europe, Australia and New Zealand and Japan, with global expansion ongoing. The Affera Mapping and Ablation System with Sphere-9 Catheter received CE Mark in March 2023 and U.S. Food and Drug Administration (FDA) approval in October 2024. The Sphere-360 catheter is approved in Europe and investigational in the United States. For more information on the Affera system, the Sphere-9 catheter and the Sphere-360 catheter, visit Medtronic.com. About Atrial Fibrillation AFib is one of the most common and undertreated heart rhythm disorders, affecting more than 60 million people worldwide1. AFib is a progressive disease, often beginning as paroxysmal AFib (presents intermittently) and progressing to persistent (lasts for more than 7+ days without stopping). As the disease progresses, the risk of serious complications including heart failure, stroke and risk of death increases2-5. About Medtronic Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic, visit and follow Medtronic on LinkedIn. Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results. References Roth GA, Mensah GA, Johnson CO et al. Global Burden of Cardiovascular Diseases and Risk Factors, 1990-2019: Update From the GBD 2019 Study. J Am Coll Cardiol 2020;76:2982-3021. Miyasaka Y, Barnes ME, Bailey KR, et al. Mortality trends in patients diagnosed with first atrial fibrillation: a 21-year community-based study. J Am Coll Cardiol 2007;49:986-92. Hindricks G, Potpara T, Dagres N, et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association of Cardio-Thoracic Surgery (EACTS). Eur Heart J 2020. Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke 1991;22:983-8. Lubitz SA, Moser C, Sullivan L, et al. Atrial fibrillation patterns and risks of subsequent stroke, heart failure, or death in the community. J Am Heart Assoc 2013;2:e000126 Dr. Reddy is a paid consultant for Medtronic. Contacts: Leslie Williamson Public Relations +1-612-227-5099 Ingrid Goldberg Investor Relations +1-763-505-2696 SOURCE Medtronic plc 21% more press release views with Request a Demo