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 https://www.mitrassist.com.cn/
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.
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