Fuwai Cardiovascular Hospital  

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

THURSDAY, Aug. 29, 2024 -- Like to sleep in on the weekends? You’re probably doing your heart a world of good, a new study shows. Weekend “catch-up” sleep can lower a person’s risk of heart disease by up to 20%, according to findings to be presented Thursday at the European Society of Cardiology’s annual meeting in London. “Sufficient compensatory sleep is linked to a lower risk of heart disease,” said researcher Yanjun Song , a cardiology expert with the Fuwai Hospital in Beijing. “The association becomes even more pronounced among individuals who regularly experience inadequate sleep on weekdays.” For the study, researchers analyzed data from nearly 91,000 participants in the long-range UK Biobank research project. As part of the project, the participants wore sleep monitors and had their heart health tracked. About 22% of the participants were sleep-deprived, getting less than seven hours of sleep per night. Sleep tracking showed which of the participants were sleeping in on the weekends, to make up for their lack of sleep during the week. After an average 14 years of follow-up, those participants who got the most catch-up sleep on the weekends were 19% less likely to develop heart disease than those who got the least, results show. That held especially true among those with daily sleep deprivation, with those getting the most catch-up sleep experiencing a 20% lower risk of heart disease, researchers said. Because these findings were presented at a medical meeting, they should be considered preliminary until published in a peer-reviewed journal. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

SHANGHAI, June 29, 2023 /PRNewswire/ -- Bioheart (02185.HK), together with its holding subsidiary Angiocare announces the clinical result for Iberis-HTN at China Interventional Therapeutics 2023. Iberis-HTN is a prospective, multicenter, blinded, randomized controlled trial to evaluate the safety and efficacy of the Iberis® Multi-Electrode Renal Artery Radiofrequency Ablation Catheter System for the treatment of primary hypertension (NCT02901704). The study was led by Academician Runlin GAO and Professor Xiongjing JIANG from Fuwai Hospital. 217 subjects were enrolled in the trial. The results showed that the RDN group achieved the primary clinical endpoint of efficacy (change in mean systolic blood pressure from baseline during 24-hour ambulatory blood pressure at 6 months after the procedures) and was significantly superior to the sham control group. The 24-hour systolic ABPM for Renal denervation (RDN) group was reduced by 11.93 mmHg compared to baseline and the sham group was reduced by 2.58 mmHg. The net change between groups is 9.35 mmHg reduction with statistical significance (P<0.0001). No device related major adverse events were observed. The safety and efficacy of Iberis® were demonstrated in the study. About Iberis®2nd: Iberis®2nd is a catheter-based, procedure for the treatment of hypertension. Iberis®2nd has filed the registration application in China, received CE mark in EU in 2016 and has finished First in Human trial in Japan. Iberis® 2nd is currently the only RDN system globally with CE marking that can be used for both transradial approach (TRA) and transfemoral approach (TFA). TRA is preferred by interventionalists with fewer access site complications, shorter hospital stays and less overall procedural cost. TRA also enables RDN therapy to be conducted on an outpatient surgery basis. Iberis® 2nd can be used with 6F guiding to achieve complete ablation of renal main artery and branches resulting in better efficacy. A post-marketing trial RADIUS-HTN was initiated in 2022 in EU to compare the effectiveness of RDN performed via TRA and TFA. The principal investigator for RADIUS-HTN is Professor Felix Mahfoud, MD from Saarland University Hospital, Homburg/Saar and the chairman of the Arterial Hypertension Working Group of the German Cardiac Society. About Bioheart: Shanghai Bio-heart Biological Technology Co., Ltd is a leading cardiovascular innovative medical device company with global reach. Bioheart's mission is 'Turn innovation into quality care'. Bioheat focuses on Bioresorbable scaffolds, Renal Denervation and Drug coated balloons addressing unmet clinical needs. SOURCE Shanghai Bio-heart Biological Technology Co., Ltd