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news.Elixir Medical has announced positive nine-month results from the Elixir Medical Excella I trial. The Excella I trial is a fifteen patient first-in-man study of the company's Excella Novolimus-Eluting Coronary Stent System.
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The eight-month angiographic follow-up continued to demonstrate reduction in late lumen loss and neointimal hyperplasia formation. In-stent late lumen loss was 0.31 ± 0.25 mm, neointimal volume obstruction was 6.0 ± 0.36 percent, and binary restenosis was zero percent. There were no MACE events or incidents of stent thrombosis through the nine-month clinical follow-up period.
Based on these sustained positive clinical results, Elixir Medical plans to initiate Excella II, a large randomized trial that will compare the Excella stent to a currently approved drug-eluting stent. The trial will recruit patients from Europe, New Zealand, and Brazil.
Motasim Sirhan, CEO of Elixir Medical, said: “We believe the Excella Novolimus-Eluting Coronary Stent System will set the industry standard in achieving excellent clinical outcomes for patients.”