Elixir Medical Has Positive First-In-Man Results from Three New Coronary DES

October 17, 2008 - Elixir Medical Corp. today announced results from three multicenter first-in-man studies of Novolimus and Myolimus eluting coronary stent systems at the 20th Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, D.C.

Twelve-month clinical results from EXCELLA I, the first-in-man study of the Novolimus eluting coronary stent system with a durable polymer, were presented by Alexandre Abizaid, M.D., Ph.D., of the Institute of Dante Pazzanese de Cardiologia in Sao Paulo, Brazil. He said at the 12-month clinical follow-up, the Novolimus eluting coronary stent system demonstrated sustained efficacy and clinical safety with no MACE events or incidents of stent thrombosis. Eight-month angiographic and IVUS follow-up demonstrated an in-stent late lumen loss of 0.31 ± 0.25 mm and a volume obstruction of 6 ± 0.36 percent.

Nine-month clinical and six month angiographic and IVUS results from the first-in-man study of the Myolimus eluting coronary stent system with the lowest known dose of an olimus drug and Elixir’s proprietary durable polymer were presented at TCT 2008 by Wolfgang Rutsch, M.D., Ph.D. of Charite Campus Mitte, Berlin, Germany. At the nine-month clinical follow-up, one patient experienced a non Q-wave myocardial infarction. Six-month angiographic and IVUS follow-up demonstrated an in-stent late lumen loss of 0.15 ± 0.11 mm and a volume obstruction of 1.4 ± 1.2 percent. There were no incidents of stent thrombosis.

Six-month clinical, angiographic and IVUS results using the Myolimus stent were presented by Dr. John Ormiston, MBChB, of Auckland City Hospital, Auckland, New Zealand. At the six-month clinical follow up, one patient experienced a non Q-wave myocardial infarction and one patient experienced a target lesion revascularization. Six-month angiographic and IVUS results from the first cohort of 15 patients demonstrated an in-stent late lumen loss of 0.37 ± 0.44 mm and a volume obstruction of 14.2 ± 7.7 percent. There were no incidents of stent thrombosis.

The stents will be further tested in the Novolimus EXCELLA II Randomized Clinical Trial scheduled to commence this quarter, said Patrick W. Serruys, M.D., Ph.D., of the Thoraxcenter, Erasmus University Hospital, Rotterdam, the Netherlands.

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