Shanghai Medical College of Fudan University

WASHINGTON, Oct. 28, 2024 /PRNewswire/ -- MitrAssist Lifesciences, a leader in innovative cardiovascular medical devices, today unveiled the initial clinical results of its groundbreaking new product, SIKELIA™, during the 2024 Transcatheter Cardiovascular Therapeutics (TCT) Conference held in Washington, D.C. The early findings demonstrate promising potential in improving outcomes for patients suffering from severe symptomatic aortic stenosis. SIKELIA transthoracic heart valve (THV) is designed for transcatheter aortic valve implantation (TAVI) procedure. It features a unique polymer leaflet design which allows enhanced durability and reduced thrombogenicity and calcification while lowering production costs. SIKELIA THV is also fully retrievable at 100% frame expansion allowing reposition in case of misplacement. The clinical trial results, involving 12 patients from 4 centers, with a maximum follow up of 27 months, revealed favorable safety and performance 1-year outcomes. A significant improvement in hemodynamic performance was demonstrated by reduced mean pressure gradient and increased effective orifice area. The functional status as assessed by NYHA class, 6-minute walk test and KCCQ score was improved significantly in all measures. In addition, at 1 year follow-up, normal leaflet mobility without hypoattenuated leaflet thickening (HALT) or calcification was confirmed in all patients. "The initial clinical results of SIKELIA™ mark a significant milestone in our mission to transform patient care," said Peggy Wang, CEO of MitrAssist. "We are excited about the potential SIKELIA has to improve outcomes for patients suffering from severe aortic stenosis. SIKELIA capabilities and these initial results provide a foundation for the next phases of clinical testing, and we look forward to continuing our work to bring this innovation to physicians and patients around the world." The presentation at the TCT Conference attracted the attention of top physicians, industry leaders and medical professionals eager to explore more about the product. Dr. Xiaochun Zhang from Zhongshan Hospital and the Shanghai Medical College of Fudan University presented the initial results of this first-in-human, prospective, single-arm, multicenter study, on behalf of the study investigators. In addition to Zhongshan Hospital, the participating centers included Fuwai Yunnan Hospital, Chinese Academy of Medical Sciences, Xiamen Cardiovascular Hospital Xiamen University and Zibo Central Hospital. "The initial outcomes we are seeing from SIKELIA™ could represent a real breakthrough in the TAVR field," said Prof. Junbo Ge from Zhongshan Hospital, principal investigator of the clinical trial. "The potential for improving patients' outcomes is immense, and we are eager to continue gathering data and enhancing the application of this technology. These results are just the beginning, and they pave the way for more comprehensive studies in the near future." For further information, please visit MITRASSIST LIFESCIENCES LIMITED is a leading global company for innovative cardiovascular medical devices, focusing on providing advanced diagnostic and therapeutic solutions for cardiovascular patients. The company product line covers a wide range of applications in the cardiovascular field from structural heart disease to heart failure. MitrAssist is dedicated and committed to innovation and improving patient care. Logo: SOURCE MitrAssist Lifesciences WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Depression has long been associated with an increased risk of dementia, and now a new study provides evidence that timely treatment of depression could lower the risk of dementia in specific groups of patients. Depression has long been associated with an increased risk of dementia, and now a new study provides evidence that timely treatment of depression could lower the risk of dementia in specific groups of patients. Over 55 million people worldwide live with dementia, a disabling neurocognitive condition that mainly affects older adults. No effective treatment for dementia exists but identifying ways to help minimize or prevent dementia would help to lessen the burden of the disease. The study, led by Jin-Tai Yu, MD, PhD, Huashan Hospital, Shanghai Medical College, Fudan University, and Wei Cheng, PhD, Institute of Science and Technology for Brain-Inspired Intelligence, Fudan University, Shanghai, China, appears in Biological Psychiatry, published by Elsevier. Professor Yu and Professor Cheng used data collected by the UK Biobank, a population-based cohort of over 500,000 participants. The current study included more than 350,000 participants, including 46,280 participants with depression. During the course of the study, 725 of the depressed patients developed dementia. Previous studies examining whether depression therapies such as pharmacotherapy and psychotherapy could lower the risk for dementia produced mixed results, leaving the question unresolved. "Older individuals appear to experience different depression patterns over time," said Professor Yu. "Therefore, intra-individual variability in symptoms might confer different risk of dementia as well as heterogeneity in effectiveness of depression treatment in relation to dementia prevention." To address that heterogeneity, the researchers then categorized participants into one of four courses of depression: increasing course, in which mild initial symptoms steadily increase; decreasing course, starting with moderate- or high-severity symptoms but subsequently decreasing; chronically high course of ongoing severe depressive symptoms; and chronically low course, where mild or moderate depressive symptoms are consistently maintained. As expected, the study found that depression elevated the risk of dementia -- by a striking 51% compared to non-depressed participants. However, the degree of risk depended on the course of depression; those with increasing, chronically high, or chronically low course depression were more vulnerable to dementia, whereas those with decreasing course faced no greater risk than participants without depression. The researchers most wanted to know whether the increased risk for dementia could be lowered by receiving depression treatment. Overall, depressed participants who received treatment had reduced risk of dementia compared to untreated participants by about 30%. When the researchers separated the participants by depression course, they saw that those with increasing and chronically low courses of depression saw lower risk of dementia with treatment, but those with a chronically high course saw no benefit of treatment in terms of dementia risk. "Once again, the course of ineffectively treated depression carries significant medical risk," said Biological Psychiatry editor John Krystal, MD. He notes that, "in this case, symptomatic depression increases dementia risk by 51%, whereas treatment was associated with a significant reduction in this risk." "This indicates that timely treatment of depression is needed among those with late-life depression," added Professor Cheng. "Providing depression treatment for those with late-life depression might not only remit affective symptoms but also postpone the onset of dementia." "The new findings shed some light on previous work as well," said Professor Cheng. "The differences of effectiveness across depression courses might explain the discrepancy between previous studies."