Universitätsklinikum Freiburg

SAN CLEMENTE, Calif.--(BUSINESS WIRE)-- Reflow Medical, Inc., a developer of innovative medical devices focused on cardiovascular disease, announces it has received CE (Conformité Européenne) Mark certification in the European Union for the Bare Temporary Spur Stent System. The device is intended to treat de novo or restenotic lesions in the infrapopliteal arteries with a commercially available drug-coated balloon (DCB) to enhance drug absorption. This press release features multimedia. View the full release here: The Bare Temporary Spur Stent System is a unique clinical solution known as Retrievable Stent Therapy, or RST. It is intended to provide stent-like results while leaving no metal behind. (Graphic: Business Wire) “The device performance and clinical study data for patients suffering from CLTI has been quite impressive,” said Professor Thomas Zeller, MD, who is Chief of the Department of Angiology at University Heart Center Freiburg in Bad Krozingen, Germany. CLTI, or chronic limb-threatening ischemia, increases the risk of mortality, amputation, and impaired quality of life. Prof. Zeller was a principal investigator in the DEEPER OUS clinical trial (NCT03807531). The Bare Temporary Spur Stent System, followed by drug-coated balloon treatment, reduces clinically driven target lesion revascularization (CD-TLR), improves wound healing, reduces recoil, and improves vessel patency through one year, compared to historical treatment outcomes with plain balloon angioplasty or a DCB alone. Marianne Brodmann, MD, is a Professor and Vascular Specialist with the Division of Angiology, Medical University Graz in Graz, Austria, and the Principal Investigator for the DEEPER LIMUS clinical trial (NCT04162418) to evaluate the Bare Temporary Spur Stent System. “We have found that the Spur allows us to treat patients with (BTK) disease using stent therapy, without the long-term risk of a stent implant,” she said. The Bare Temporary Spur Stent System is a unique clinical solution intended to provide stent-like results while leaving no metal behind. Known as Retrievable Stent Therapy, or RST, the self-expanding stent is designed with radial spikes for creating channels in the vessel wall to enhance drug absorption and reduce recoil. The stent is then recaptured, removed, and treated with a commercially available drug-coated balloon. “Earning the CE Mark is a huge milestone for the company. It enables us to offer a clinically validated solution to an unmet need in a major disease area,” said Isa Rizk, Reflow Medical’s Co-Founder and CEO. “Our next goal is to expand our organization to commercialize this breakthrough technology and serve the needs of physicians and their patients in countries accepting this certification.” The Reflow Medical Bare Temporary Spur Stent System was granted certification as a Class IIa medical device under the European Union Medical Device Regulation (2017/745). The EU MDR is a rigorous process that requires manufacturers to provide substantial evidence of their device’s performance and safety. About Reflow Medical, Inc. Reflow Medical, Inc., established in 2011, is a private company focused on empowering physicians through the design and development of innovative and effective technologies for treating cardiovascular disease. View source version on businesswire.com: Contacts Jennifer Carlyle jcarlyle@reflowmedical.com 949-481-0399 Source: Reflow Medical, Inc. Smart Multimedia Gallery Photo The Bare Temporary Spur Stent System is a unique clinical solution known as Retrievable Stent Therapy, or RST. It is intended to provide stent-like results while leaving no metal behind. (Graphic: Business Wire) View this news release and multimedia online at:

CHICAGO, Nov. 22, 2023 /PRNewswire/ -- People with long COVID exhibit patterns of changes in the brain that are different from fully recovered COVID-19 patients, according to research being presented next week at the annual meeting of the Radiological Society of North America (RSNA). "To the best of our knowledge, this is the first study comparing patients with long COVID to both a group without history of COVID-19 and a group that went through a COVID-19 infection but is subjectively unimpaired," said one of the study's lead authors, Alexander Rau, M.D., resident in the Departments of Neuroradiology and Diagnostic and Interventional Radiology at University Hospital Freiburg in Freiburg, Germany. After infection with COVID-19, as many as 10-25% of patients may develop a post-COVID condition commonly referred to as "long COVID." People with long COVID may experience a wide variety of symptoms, including difficulty concentrating ("brain fog"), change in sense of smell or taste, fatigue, joint or muscle pain, shortness of breath, digestive symptoms, and more. These symptoms may persist for weeks, months, or—as is only now becoming apparent—years after COVID-19 infection. However, the basis of this condition is poorly understood. Diffusion microstructure imaging (DMI), a novel MRI technique, is a promising approach to fill this gap. DMI looks at the movement of water molecules in tissues. By studying how water molecules move in different directions and at various speeds, DMI can provide detailed information on the microstructure of the brain. It can detect even very small changes in the brain, not detectable with conventional MRI. For this prospective, cross-sectional study, Dr. Rau and colleagues compared MRI brain scans of three groups: 89 patients with long COVID, 38 patients that had contracted COVID-19 but did not report any subjective long-term symptoms, and 46 healthy controls with no history of COVID-19. The researchers first compared the cerebral macrostructure of these three groups to test for atrophy or any other abnormalities. Next, they used DMI to gain a deeper insight into the brain. The three groups were compared to reveal group differences in the brain's microstructure. DMI parameters were read for the gray matter in the brain. Additionally, whole brain analyses were employed to reveal the spatial distribution of alterations and associations with clinical data, including long-COVID symptoms like fatigue, cognitive impairment or impaired sense of smell. The results showed no brain volume loss or any other lesions that might explain the symptoms of long COVID. However, COVID-19 infection induced a specific pattern of microstructural changes in various brain regions, and this pattern differed between those who had long COVID and those who did not. "This study allows for an in vivo insight on the impact of COVID-19 on the brain," Dr. Rau said. "Here, we noted gray matter alterations in both patients with long-COVID and those unimpaired after a COVID-19 infection. Interestingly, we not only noted widespread microstructural alterations in patients with long COVID, but also in those unimpaired after having contracted COVID-19." The findings also revealed a correlation between microstructural changes and symptom-specific brain networks associated with impaired cognition, sense of smell and fatigue. "Expression of post-COVID symptoms was associated with specific affected cerebral networks, suggesting a pathophysiological basis of this syndrome" Dr. Rau said. The researchers hope to reexamine the patients in the future, recording both clinical symptoms and changes to the brain's microstructure. Despite these brain imaging findings, it remains unclear why some people develop long COVID while others do not, although previous studies have identified risk factors including female sex, older age, higher body mass index, smoking, preexisting comorbidities, and previous hospitalization or intensive care unit admission. Co-authors are Jonas A. Hosp, M.D., Nils Schroter, M.D., Marco Reisert, Ph.D., Horst Urbach, M.D., Cornelius Weiller, M.D., and Elias Kellner, Ph.D. Note: Copies of RSNA 2023 news releases and electronic images will be available online at RSNA.org/press23. RSNA is an association of radiologists, radiation oncologists, medical physicists and related scientists promoting excellence in patient care and health care delivery through education, research and technologic innovation. The Society is based in Oak Brook, Illinois. (RSNA.org) Editor's note: The data in these releases may differ from those in the published abstract and those actually presented at the meeting, as researchers continue to update their data right up until the meeting. To ensure you are using the most up-to-date information, please call the RSNA Newsroom at 1-312-791-6610. For patient-friendly information on brain MRI, visit RadiologyInfo.org. SOURCE Radiological Society of North America (RSNA)

Registry subjects will initially enroll in multiple hospitals in Germany, where the Revita System has already obtained a CE Mark and reimbursement through the NUB reimbursement process LEXINGTON, Mass.--(BUSINESS WIRE)-- Fractyl Health, a commercial stage organ-editing metabolic therapeutics company focused on pioneering new approaches for the treatment of type 2 diabetes (T2D), today announces the initiation of its Revita® Global Registry Program in Germany. On April 20, the Ethics Committee of the University of Freiburg (Germany) granted a clearance for the initiation of a registry study of the Revita System in German hospitals. Patients who participate in the registry will be those with inadequately controlled type 2 diabetes (T2D) despite guideline-directed medical therapy and are interested in undergoing the Revita procedure. Data will be collected to understand the impact of Revita on important clinical, patient-relevant, and health-economic outcomes associated with T2D. “Nearly 50% of patients remain inadequately controlled with T2D, and therefore, there is a need for new therapeutic options that can improve real-world outcomes in the disease,” said Prof. Jochen Seufert, FRCPE, Head of the Department of Endocrinology and Diabetology at University Hospital Freiburg and principal investigator for the registry study in Germany. “This registry study will enable us to collect valuable data on Revita under real-world conditions to help better understand the value it may provide to people with the disease.” The registry aims to collect data from patients receiving the Revita procedure at Munich Municipal Hospital (Bogenhausen) and Evangelical Hospital Düsseldorf (EVK) in collaboration with the West German Diabetes and Health Centre (WDGZ) in Düsseldorf. “There is a huge, global unmet need for people with inadequately controlled T2D,” said Harith Rajagopalan, MD, PhD, Co-Founder and CEO of Fractyl Health. “We believe the Revita System has the potential to offer an important new solution for patients because targeting the gut may allow us to address a root cause of the disease for the first time.” About Fractyl Health Fractyl Health is focused on pioneering new approaches to the treatment of T2D. Despite advances in treatment over the last 50 years, metabolic diseases in general, and T2D, in particular, continue to be a principal and rapidly growing driver of morbidity and mortality in the 21st century. Fractyl Health’s goal is to transform T2D treatment from chronic blood glucose management to disease-modifying therapies that target the organ-level root causes of the disease. Fractyl Health is a private organ-editing metabolic therapeutics company based in Lexington, MA. For more information, visit or About Revita® Fractyl Health’s lead product candidate, Revita®, is based on the company’s insights surrounding the potential role of the gut in metabolic diseases. Revita is designed to remodel the duodenal lining via hydrothermal ablation (i.e., duodenal mucosal resurfacing) to edit abnormal intestinal nutrient sensing and signaling mechanisms that are a potential root cause of metabolic diseases. Revita has received a CE mark in Europe and, in January 2022, received reimbursement authorization through NUB in Germany. In the United States, Revita is for investigational use only under US law.