Chronic Limb-Threatening Ischemia

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

MOUNTAIN VIEW, Calif., April 22, 2025 (GLOBE NEWSWIRE) -- R3 Vascular Inc., a medical device company dedicated to developing and providing novel, best-in-class bioresorbable scaffolds for treating peripheral arterial disease (PAD), is pleased to announce that the first patient in its ELITE-BTK pivotal trial was treated by Dr. Brian DeRubertis, FACS, Chief of the Division of Vascular & Endovascular Surgery at New York-Presbyterian and Weill Cornell Medicine in New York City. The trial evaluates R3 Vascular’s next generation drug eluting bioresorbable scaffold, MAGNITUDE®, for below-the-knee (BTK) PAD, which according to the American Heart Association affects more than 200 million people globally, and 10 to 12 million in the U.S. older than the age of 40. The most common type of PAD affects the lower-extremity where blood flow is reduced to the legs and feet. Each year, approximately 150,000 leg amputations are performed in the U.S. alone. “The treatment of the first patient in our ELITE-BTK pivotal trial by distinguished vascular surgeon and researcher Dr. Brian DeRubertis is a significant milestone as we commence our effort to fully demonstrate the efficacy and safety of our next generation MAGNITUDE scaffold,” said Christopher M. Owens, President and Chief Executive Officer of R3 Vascular. “Moving forward we look to accelerate enrollment, paving the way for a PMA market application with the FDA.” Dr. DeRubertis commented on the importance of the ELITE-BTK pivotal trial, saying, “I am honored to have enrolled the first two patients in R3 Vascular’s ELITE-BTK pivotal trial, primarily because this type of technology has been needed by our patients for years. I have spent much of my career researching novel devices for vascular disease, including bioresorbable scaffolds, and while there have been some recent successes in the BTK PAD trial landscape, there remain significant unmet needs in this area. We expect the results of this important trial will reveal MAGNITUDE’s unique potential to further advance treatment and improve patient outcomes for patients with vascular disease.” “The start of this trial marks the continuation of our journey in providing a ground-breaking technology for patients who have suffered from this debilitating disease for many years without effective therapeutic options,” said Kamal Ramzipoor, Founder and Chief Technology Officer of R3 Vascular. “MAGNITUDE is a next generation bioresorbable scaffold with the potential to address one of the greatest needs for patients suffering from Chronic Limb-Threatening Ischemia due to below-the-knee PAD. R3 Vascular’s novel bioresorbable scaffolds are made from a unique, ultra-high molecular weight polylactic acid polymer. This polymer, combined with the company’s scaffold design and proprietary processing technology allow for superior biomechanical properties with strength and ductility. We believe these properties will drive extremely positive outcomes, especially long-term for real-world patients. We look forward to advancing our product through its clinical development with the ultimate goal of having a market leading position.” As an active researcher, Dr. DeRubertis has participated in more than 15 clinical research studies as a Site or National Principal Investigator, many of which focus on the challenging area of BTK disease. He has published more than 70 articles in peer-reviewed journals, as well as more than 15 book chapters. As frequent speaker, he has presented original research at over 35 regional and national academic conferences and has been an invited speaker at numerous national and international symposia delivering over 350 presentations at these conferences. About R3 Vascular Inc.R3 Vascular is a privately-held medical device company that has developed a novel technology platform for the next generation of fully bioresorbable drug eluting sirolimus coated vascular scaffolds. These are designed to deliver the ‘stent-like’ support of a scaffold along with the anti-inflammatory and anti-proliferative result of sirolimus, but ‘disappearing’ over time as the vessel heals. R3 Vascular is headquartered in Mountain View, California. More information can be found at www.r3vascular.com. Media Contact:David Gutierrez, Dresner Corporate Services, (312) 780-7204, dgutierrez@dresnerco.com

WOBURN, Mass., March 20, 2025 /PRNewswire/ -- Micro Medical Solutions (MMS), a pioneering medical device startup focused on revolutionizing the treatment of Critical Limb Ischemia (CLI), is proud to announce the appointment of a distinguished Board of Directors. This distinguished leadership will provide strategic guidance as MMS advances its groundbreaking medical technologies to improve patient outcomes worldwide. Along with MMS CEO & Chairman of the Board, Greg Sullivan, the newly appointed Board of Directors includes: John Fletcher, Managing Partner Emeritus, Fletcher Spaght, Inc. John currently serves as Chairman of the Board of Directors for ClearPoint Neuro, Koru Medical, Metabolon and Optinose. He served as Chairman of Spectranetics during its turnaround and subsequent sale to Philips N.V. For this work as well as his work on the board of Axcelis Corporation, he was selected as Director of the Year by the National Association of Corporate Directors. He is Chairman Emeritus of the Corporate Collaboration Council at the Thayer School of Engineering/Tuck School of Business at Dartmouth College and serves on the Board of Advisors of Beth Israel Deaconess Medical Center and the Whitehead Institute at MIT. George Quinoy is a seasoned C-suite executive with a proven track record of building and scaling commercial enterprises in the vascular space. He has led high-growth strategies that resulted in successful acquisitions by key industry leaders. Throughout his career, George has played a pivotal role in driving rapid and sustained expansion for renowned companies, including AVE, Medtronic, ACS/Guidant, Volcano Corp, and most recently, Provisio Medical. His leadership continues to shape the vascular innovation and commercialization. Joseph Ruggio, MD,a renowned cardiologist and founder, and president of Pacific Cardiovascular Associates Medical Group, Inc. (PCA). Dr. Ruggio serves as President and Chief Medical Officer of Via Vitae MSO, LLC, a partnership with Optum Specialty Practices. Board-certified in internal medicine, cardiovascular diseases, and interventional cardiology, he brings extensive clinical and leadership expertise. Ronald Solar, PhD, Dr. Ronald Solar received his Ph.D. in Biomaterials and Materials Science from the University of Pennsylvania and has been designing and developing medical devices for over 45 years. He co-founded several successful medical device companies, including Y Med (sold to CR Bard), X Technologies (sold to Guidant), Pameda/Occam (sold to Cordis) and Versaflex (sold to Medtronic). Dr. Solar also played key leadership and development roles for Edwards Life Sciences, Advanced Cardiovascular Systems, SciMed and Medtronic. He currently holds over 68 US patents. "We are honored to welcome such an eminent group of experts to our Board," said CEO, Greg Sullivan. "Their collective experience in medical device innovation, regulatory strategy, and market expansion will be instrumental as we scale our transformative solutions, like the MicroStent™, to meet the evolving critical vascular challenges of interventionalists and their patients" About MMS For more information about Micro Medical Solutions and its mission to transform healthcare, visit . Media Contact: Peg Thornton VP, Strategic Initiatives [email protected] 732-616-9123 SOURCE Micro Medical Solutions WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED