Data demonstrated the potential to improve outcomes for patients suffering from severe symptomatic aortic stenosis, according to a news release. The company reported findings at Transcatheter Cardiovascular Therapeutics (TCT) 2024 in Washington, D.C.
MitrAssist designed the Sikelia system for transcatheter aortic valve implantation (TAVI) procedures. It features a unique polymer leaflet design, allowing for enhanced durability and reduced thrombogenicity and calcification. The design also helps lower production costs.
Sikelia THV is also fully retrievable at 100% frame expansion, allowing for repositioning in case of misplacement. With a self-expanding nitinol wire frame, the polymer valve has a lifespan of 25 years. Its unique design makes it independent of radial support, greatly reducing the incidence of perioperative conduction block complications.
Results came from 12 patients across four centers, with a maximum follow-up of 27 months. MitrAssist reported favorable safety and performance at one year. Reduced mean pressure gradient and increased effective orifice area demonstrated a significant improvement in hemodynamic performance.
Investigators reported improved functional status as assessed by NYHA class, 6-minute walk test and KCCQ score. At one-year follow-up, all patients had confirmed normal leaflet mobility without hypoattenuated leaflet thickening (HALT) or calcification.
“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.”
