Elixir Medical Corp. (Sunnyvale, CA) has received CE (Conformité Européenne) Mark approval for a coronary scaffold system designed to degrade in about one year, returning the patients' coronary vessels to a normal condition. The DESSolve scaffold combines a proprietary poly-L Lactide (PLLA) plastic with an anti-proliferative drug called Novolimus.
"The CE Mark approval for DESolve brings to the market a differentiated product platform with important advantages," said Martin Leon, chairman of the DESolve Scaffold Program. "Elixir's DESolve may help to transform the interventional treatment of patients with coronary artery disease by providing optimal vessel support when needed and degrading in about a year leaving the vessel free of a permanent metallic implant."
Results of an international trial designed to enroll 120 patients at 15 centers in Europe, Brazil and New Zealand were submitted as part of the CE Mark application, and were presented today in Paris at the "From Late Breaking Trial to Clinical Practice" session of EuroPCR 2013....