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, SIKELIATM, 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 SIKELIATM mark a significant milestone in our missio.
