Peripheral arterial occlusive disease

SELUTION SLR™ Drug-Eluting Balloon (DEB) achieves amongst the highest reported patency for any drug-eluting or drug-coated technology at 3 years in the SELUTION SFA Japan Trial, with 81.5% primary patency. SELUTION SLR™ DEB demonstrates real-world effectiveness and consistency across complex and varied patient populations. The SUCCESS Study 12-month primary endpoint showed: Freedom from CD-TLR – overall population of 91.1%, claudicants 91.3%, and CLTI 90.3%. MIAMI LAKES, Fla., April 24, 2025 /PRNewswire/ -- Cordis, a global leader in interventional cardiovascular and endovascular technologies, announced new data from two major peripheral studies evaluating the SELUTION SLR™ Drug-Eluting Balloon (DEB). The SUCCESS PTA Study 12-month results were presented on April 23 at the Charing Cross Symposium in London. The SELUTION SFA Japan Trial 3-year results followed on April 25 at the Japan Endovascular Treatment Conference in Osaka. The studies confirm the sustained efficacy and safety of SELUTION SLR™ DEB in treating complex peripheral artery disease (PAD) across diverse, real-world patient populations, favorably matching best-in-class benchmarks from paclitaxel-eluting technologies. Continue Reading Cordis, a global leader in interventional cardiovascular and endovascular technologies, announced new data from two major peripheral studies evaluating the SELUTION SLR™ Drug-Eluting Balloon (DEB). 3-Year Results – SELUTION SFA Japan Trial: First Sirolimus DEB with Proven Long-Term Outcomes The SELUTION SFA Japan trial, a prospective, single-arm trial conducted at 13 sites across Japan, evaluated the performance of SELUTION SLR™ DEB in 134 complex patients. At 3 years, SELUTION SLR™ DEB demonstrated primary patency of 81.5% and freedom from Clinically Driven Target Lesion Revascularization (CD-TLR) of 93.8%. These results demonstrate that SELUTION SLR™ DEB is the only drug-eluting technology with core-lab adjudicated 3-year patency over 80%. "SELUTION SLR™ DEB represents the next evolution in Leave-Nothing-Behind treatment strategies. These 3-year outcomes demonstrate unprecedented durability in complex patients with primary patency greater than 80%. In contrast, paclitaxel drug-coated balloon studies have shown significant loss of patency in the same time period," said Dr. Iida, MD, of the Cardiovascular Division at Osaka Police Hospital, Japan and Study Principal Investigator. 12-Month Outcomes – The SUCCESS PTA Study: Real-World Results in a PAD Population The SUCCESS PTA Study is a prospective, observational global registry evaluating SELUTION SLR™ DEB in 723 patients across 27 sites in Europe, Asia, and South America. The study population reflects real-world practice, with 74.2% of patients presenting with claudication and 25.8% with chronic limb-threatening ischemia (CLTI). The primary endpoint—freedom from CD-TLR at 12 months—was consistently high: 91.1% in the overall population, 91.3% in claudicants, and 90.3% in CLTI patients. Clinical improvements were seen across the patient cohorts with 88.1% of patients improving by at least one Rutherford category. "Leveraging SELUTION SLR™ DEB with its unique sirolimus MicroReservoir technology delivers unequivocal clinical benefits in complex patient cohorts," said Dr. Michael Lichtenberg, Chief of Interventional Angiology at Klinikum Hochsauerland, Germany, CMO and Director of Vascular Center Clinic, Germany, and Study Principal Investigator. "These real-world results demonstrate consistent safety and effectiveness in both claudicant and CLTI patients." Drug Elution, Done Better – Sustained Sirolimus Release Improves Outcomes "At Cordis, our focus is always on advancing therapies that offer meaningful, lasting impact for patients—and these results do exactly that," said Dr. George Adams, Chief Medical Officer at Cordis. "The SELUTION SLR™ studies showcase drug elution, done better – sustained sirolimus delivery results in unmatched and durable efficacy, uncompromised safety and consistent robust real-world data across diverse PAD populations. This is the kind of innovation that truly elevates patient care." About Cordis Cordis is a global leader in the development and manufacturing of interventional cardiovascular and endovascular technologies. For over 60 years, we have been committed to improving patient lives through innovation, enhanced clinical outcomes, education, and service. Our mission is to be the heart of innovation to transform cardiovascular care. For more information about Cordis, please visit Cordis.com and follow Cordis on LinkedIn. Media Contact: Kelly May Director of Corporate Communications [email protected] SOURCE Cordis WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Initial 20 Patients Enrolled in the First-in-Human Trial Had a 0% Rate of Reintervention. LOS ALTOS, Calif., April 23, 2025 /PRNewswire/ -- The initial long-term results from EFEMORAL I were presented today by Principal Investigator Prof. Andrew Holden (Auckland City Hospital, Auckland, New Zealand) at the Charing Cross Symposium in London, UK. EFEMORAL I is a first-in-human clinical trial evaluating the performance of the Efemoral Vascular Scaffold System (EVSS) for the treatment of patients suffering symptomatic peripheral arterial occlusive disease from atherosclerosis of the femoropopliteal artery. The results from the initial 20 patients enrolled across four sites in Australia and New Zealand were presented. The key findings included: Continue Reading Mean lesion length of 5.1 ± 2.0 mm 0 ± 15% post-procedure residual stenosis 0% acute/subacute thrombosis 0.41 ± 1.0 mm late lumen loss at 6 months (angiographic subset, n=10) 4.74 ± 0.86 mm mean minimal lumen diameter at 6 months (angiographic subset, n=10) Median follow-up of 2 years 100% primary patency at 3 years 100% freedom from target lesion revascularization at 3 years Sustained improvement in clinical outcome and walking tolerance at 3 years "The 0% post-procedure residual stenosis in EFEMORAL I is the lowest ever reported for a femoropopliteal trial." Post this "In this first patient experience, I found the EVSS to be simple to deploy and strong enough so that I can fully restore the original arterial lumen diameter at the time of the procedure. Furthermore, it elutes a relatively high dose of Sirolimus over several months, leading to excellent long-term outcomes, all without the need for a permanent implant," stated Prof. Holden. "I'm looking forward to expanding my use of this device in more patients with more complex lesions." The EVSS offers a new approach to treating peripheral arterial disease (PAD) by addressing the specific anatomical challenges and complex biomechanics of patients with athero-occlusive disease in the leg. Through the use of inter-scaffold spaces, the patented FlexStep Technology combines flexibility with support to accommodate tortuosity and skeletal movement, while the balloon-expandable deployment system easily opens vessels and sustains healthy blood flow. The novel bioresorbable scaffold with long-term Sirolimus elution aims to restore normal vessel diameter at the time of the procedure, deliver therapeutic benefits across all lesion lengths and morphologies, prevent restenosis, and maintain patency while leaving no permanent implant behind. "Compared to balloon angioplasty or self-expanding nitinol stents that are commonly used to treat patients with narrowing in their femoropopliteal artery, balloon expandable scaffolds with high radial strength, such as the EVSS, allow for a more complete expansion of the vessel at the index procedure," said Lewis B. Schwartz, MD, Co-Founder and CMO of Efemoral Medical. "A low residual stenosis means the lumen of the vessel has been restored to its original diameter and is a predictor of favorable long-term outcomes. The 0% post-procedure residual stenosis in EFEMORAL I is the lowest ever reported for a femoropopliteal trial, while the mean minimal lumen diameter of 4.74 mm at 6 months is the highest ever reported." "The EVSS represents a new paradigm in peripheral interventions," said Christopher Haig, Co-Founder and CEO of Efemoral Medical. "It's easy to deploy, has high radial strength, can be made in longer lengths, and offers the promise of durable outcomes without the need for a permanent implant." About Peripheral Arterial Disease (PAD) PAD, also known as "poor circulation" or "hardening of the arteries," is a global plague. Worldwide, it affects approximately 200 million people1, including an estimated 20 million people in the United States2. Left untreated, PAD can lead to severe disability and extremity amputation. The effectiveness of current interventional treatment remains limited, with up to 50% of conventional endovascular procedures complicated by failure or recurrence within the first year.3 About Efemoral Medical, Inc. Efemoral Medical, Inc. is developing next-generation bioresorbable solutions to treat patients with vascular disease. The company's initial product, the Efemoral Vascular Scaffold System (EVSS) with FlexStep Technology, is designed to offer a dedicated strategy for PAD interventions. The Efemoral Vascular Scaffold System (EVSS) is an OUS Investigational Device only. To learn more, please visit efemoralmedical.com. 1 2 Yost, The True Prevalence of PAD and the Economics of Major Amputation Endovascular Today, May 2021 3 SOURCE Efemoral Medical WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Bagsværd, Denmark, 29 March 2025 – Novo Nordisk today presented the full results from STRIDE, a phase 3b peripheral artery disease (PAD) outcomes trial investigating the effects of once-weekly injectable Ozempic ® (semaglutide 1.0 mg) in adults with type 2 diabetes and PAD, at the American College of Cardiology's (ACC) Annual Scientific Session and Expo in Chicago, US 1 . These new data from the phase 3 trial were featured during a late-breaking clinical trial session at the ACC and simultaneously published today in The Lancet 2 . The double-blind, randomised, placebo-controlled STRIDE trial achieved its primary endpoint, with semaglutide 1.0 mg demonstrating a superior and clinically meaningful improvement of 13% in maximum walking distance and a mean treatment difference of 39.9 meters on a steep incline, compared to placebo at week 52. The trial also demonstrated superiority to placebo for all confirmatory secondary outcomes assessed, including pain-free walking distance at week 52, health-related quality of life (Vascular Quality of Life Questionnaire-6) at week 52, and maximum walking distance at week 57 1 . “Peripheral artery disease (PAD) may cause severe symptoms, physical limitations, and a diminished quality of life, often making even short walks, such as retrieving the mail challenging. In individuals with PAD and diabetes, the disease can be even more severe, affecting small blood vessels and limiting the effectiveness of revascularization procedures and other treatments. Semaglutide 1.0 mg is the first medication in over two decades to show improvements in cardiometabolic and cardiovascular outcomes as well as meaningful improvements in functional capacity and quality of life, which could address a critical unmet need for those with both PAD and type 2 diabetes," said Marc P. Bonaca, MD, Director of Vascular Research, University of Colorado School of Medicine, Lead Investigator of the STRIDE trial. “The significant improvements in walking distance and patient-reported quality of life observed with semaglutide 1.0 mg in the STRIDE trial are promising and represent an important step forward on the path to advancing treatment options for this patient population.” PAD is a severe form of atherosclerotic cardiovascular disease that is under-screened and underdiagnosed and impacts approximately 230 million people globally 3 . Type 2 diabetes is one of the leading risk factors for PAD, and nearly one in three people with PAD have type 2 diabetes 4 . There are limited therapies available to specifically improve functional limitations in PAD, representing a significant unmet need in this population 5 . “Novo Nordisk continues to evolve its focus beyond diabetes and obesity towards a broader spectrum of metabolic and cardiovascular health,” said Martin Holst Lange, executive vice president for Development at Novo Nordisk. “These data, alongside other data being presented at ACC, reinforce the comprehensive set of health benefits of semaglutide, making it a strong option for healthcare professionals addressing the spectrum of metabolic and cardiovascular health – and our continued leadership in the space.” The safety results from the STRIDE trial are consistent with the well-established safety and tolerability profile of once-weekly semaglutide 1 , supported by long-term safety data with more than 33 million patient-years of exposure 6 . Serious adverse events (SAEs) were reported in fewer participants in the semaglutide group than in the placebo group (74 [19%] vs 78 [20%]). SAE probably related to treatment occurred in 2 participants (1%) in the semaglutide group and in 2 participants (1%) in the placebo group. SAE possibly related to treatment occurred in 3 (1%) and 4 (1%) participants, respectively. SAEs leading to permanent treatment discontinuation of semaglutide or placebo were less common in the semaglutide group than in the placebo group (11 [3%] vs 13 [3%]). SAEs led to the death of 3 (1%) and 8 (2%) participants in the semaglutide and placebo arms, respectively; however, no SAEs leading to death were treatment-related 1 . Based on data from the STRIDE clinical trial, Novo Nordisk submitted a label extension application for Ozempic ® to the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). A decision is anticipated in 2025. About STRIDE STRIDE is a double-blind, randomised, placebo-controlled phase 3b clinical trial assessing the benefit of once-weekly injectable semaglutide 1.0 mg, marketed as Ozempic ® , on functional capacity. It enrolled 792 participants with type 2 diabetes and symptomatic PAD with walking-induced leg pain. The primary endpoint was maximum walking distance on a constant load treadmill for people treated with semaglutide compared to placebo at week 52. STRIDE is the only dedicated PAD functional outcomes trial with a GLP-1 RA. About PAD Lower extremity PAD is a severe form of atherosclerotic cardiovascular disease. The classical symptom is intermittent claudication, associated with limited walking ability and poor health-related quality of life 7 . Type 2 diabetes is one of the leading risk factors for PAD; nearly one in three people with PAD have type 2 diabetes 4 . While anti-atherosclerotic therapies and lifestyle changes are recommended, there are no effective therapies to specifically improve functional outcomes in PAD and type 2 diabetes 8 . About Ozempic ® Ozempic ® (semaglutide) injection 0.25, 0.5 mg, 1.0 mg or 2.0 mg is a once-weekly GLP-1 RA indicated, along with diet and exercise, to improve blood sugar (glucose) in adults with type 2 diabetes mellitus and to reduce the risk of major cardiovascular events such as heart attack, stroke or death in adults with type 2 diabetes mellitus with known heart disease 9,10 . Ozempic ® is currently marketed in 75 countries and 7 million people with type 2 diabetes are currently being treated with Ozempic ® worldwide 11 . About Novo Nordisk Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs about 76,300 people in 80 countries and markets its products in around 170 countries. Novo Nordisk's B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com, Facebook , Instagram , X , LinkedIn and YouTube . Contacts for further information _______________________ References 1.   Bonaca M, et al. Oral presentation presented at the American College of Cardiology Congress Scientific Session & Expo 2025; 29–31 March 2025. Presentation 102-09. 2. The Lancet : https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)00509-4/fulltext 3.   Gornik HL, et al. Circulation. 2024;149:e1313–e1410. 4.   Thiruvoipati T, et al. World J Diabetes. 2015;6:961–969. 5.   Aronow WS. Arch Med Sci. 2012;8:375–388. 6.   Bonaca MP, et al. Eur Heart J Cardiovasc Pharmacother. 2025;10:728–737. 7.   Novo Nordisk Data on File. 8.   Sillesen H, et al. European Heart Journal. 2021;42:ehab724.2027. 9.   Ozempic ® (semaglutide): SmPC. 2025 [online] Available at: https://www.ema.europa.eu/en/documents/product-information/ozempic-epar-product-information_en.pdf Last accessed: March 2025. 10.   Ozempic ® (semaglutide) US PI. 2025 [online] Available at: https://www.novo-pi.com/ozempic.pdf Last accessed: March 2025. 11.   Novo Nordisk Data on File. IQVIA Ozempic and Rybelsus patient numbers March 2025.