Elixir Medical Corporation Announced Positive First-In-Man Results from Three Drug Eluting Coronary Stent Systems
Results Demonstrate Excellent Feasibility and Clinical Safety
Transcatheter Cardiovascular Therapeutics DES Summit (TCT 2008)
SUNNYVALE, Calif. & WASHINGTON--(BUSINESS WIRE)--October 16, 2008--Elixir Medical Corporation, a developer of products that combine state-of-the-art medical devices with advanced pharmaceuticals, announced results from three multicenter first-in-man studies of Novolimus and Myolimus eluting coronary stent systems. Findings were presented at the 20th Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium.
"Elixir is committed to be a leader in drug eluting stents by addressing physician and patient needs through the efficient development of a broad and innovative portfolio of products," said Motasim Sirhan, chief executive officer of Elixir Medical Corporation. "We are excited about the promise of both Novolimus and Myolimus in combination with our proprietary cobalt chromium alloy stent system and polymer technologies."
"I am impressed with Elixir's broad product portfolio and the company's ability to execute on multiple programs in parallel," said Professor Patrick W. Serruys, M.D., PhD, of the Thoraxcenter, Erasmus University Hospital, Rotterdam, the Netherlands who chaired the company's breakfast symposium today at TCT. "I look forward to initiating the Novolimus EXCELLA II Randomized Clinical Trial scheduled to commence this quarter."
Novolimus Eluting Coronary Stent System with a Durable Polymer: Twelve-Month Clinical Results
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 Professor Alexandre Abizaid, M.D., Ph.D., of the Institute of Dante Pazzanese de Cardiologia in Sao Paulo, Brazil at TCT 2008.
At the twelve 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 ± 0.36 percent.
Myolimus Eluting Coronary Stent System with a Durable Polymer: Nine-Month Clinical and Six-Month Angiographic Results
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 Professor 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.
Myolimus Eluting Coronary Stent System with a Bioabsorbable Polymer: Six-Month Clinical and Angiographic Results
Six-month clinical, angiographic and IVUS results from the first-in-man study of the Myolimus eluting coronary stent system with Elixir's proprietary bioabsorbable polymer were presented at TCT 2008 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.
About Novolimus and Myolimus
Novolimus and Myolimus are macrocyclic lactones in the same family as Rapamycin. The macrocyclic lactone drugs represent the most widely utilized drug family for drug eluting stent applications and have an established safety and efficacy profile.
About Elixir Medical
Elixir Medical Corporation, a privately held company headquartered in Sunnyvale, California, develops products that combine state-of-the-art medical devices with advanced pharmaceuticals to provide innovative treatment solutions to patients worldwide. The company's next-generation drug-eluting stent systems are designed to optimize localized drug delivery to provide a safe and effective treatment for cardiovascular patients. For more information, visit www.elixirmedical.com.