Healthcare Industry News: Elixir Medical
News Release - October 22, 2007
Elixir Medical Announces Positive Clinical Results for the Company's First Drug Eluting Coronary StentNovolimus Eluting Stent System Demonstrates Promising Safety and Efficacy Clinical Profile
WASHINGTON & SUNNYVALE, Calif.--(HSMN NewsFeed)--Elixir Medical, a developer of innovative drug eluting stent platforms for the treatment of cardiovascular disease, announced four-month results for EXCELLA, a first-in-man clinical trial of the company’s Novolimus™ Eluting Coronary Stent. Results were presented at the Cardiovascular Research Foundation’s (CRF) nineteenth annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, D.C., by Alexandre Abizaid, M.D., Ph.D., chief of Coronary Interventions at the Institute Dante Pazzanese de Cardiologia in São Paulo, Brazil.
Elixir Medical’s Novolimus Eluting Coronary Stent system was effective in reducing lumen loss and neointimal hyperplasia at four-month angiographic follow-up in patients treated with the device. The in-stent late lumen loss was 0.15 ± 0.29 mm and the neointimal volume obstruction as measured by intravascular ultrasound (IVUS) was 2.7 ± 2.7 percent. There were no MACE events or incidents of stent thombosis reported through the four-month follow-up period. Acute device success was achieved in all patients.
“Elixir’s Novolimus Eluting Stent looks promising as a next-generation drug eluting stent system for the treatment of cardiovascular disease,” said Professor Abizaid. “I look forward to long-term data in more complex patient groups to confirm these excellent results.”
The trial enrolled 15 patients with ischemic heart disease in Brazil having single de novo native coronary artery lesions. The primary endpoint of the study was in-stent late lumen loss at four months. Secondary endpoints include major adverse cardiac events (MACE). In addition, serial IVUS was performed on all patients at baseline and four-month follow-up.
“The clinical results of the EXCELLA trial validate the safety and effectiveness profile of the Novolimus Coronary Stent system in preclinical studies,” said Guy Leclerc, M.D., chief of Interventional Cardiology at the University of Montreal, Canada, who presented extensive preclinical data on Elixir’s Novolimus Eluting Stent System at TCT.
“The positive EXCELLA results mark a significant milestone for our company,” said Motasim Sirhan, chief executive officer, Elixir Medical Corporation. “We are excited about the opportunity to participate in this dynamic industry and bring forward innovative DES product platforms.”
About Elixir Medical’s Novolimus Eluting Coronary Stent System
Novolimus is a proprietary pharmacologic compound with anti-proliferative and immunosuppressive properties developed for drug eluting stent therapy. The stent is coated with a durable polymer coating technology to control the release of Novolimus. Elixir Medical’s Novolimus Eluting Coronary Stent System is designed to provide safety and efficacy with a substantially lower polymer load and lower drug dose than currently commercially available drug eluting stent systems.
About Elixir Medical
Elixir Medical Corporation develops state-of-the-art drug eluting stent systems for the treatment of cardiovascular disease. The company has a strong pipeline of drug eluting stent systems with durable and biodegradable polymer release technologies and fully biodegradable stent platforms. Privately held, Elixir Medical is based in the San Francisco Bay Area. For more information, visit www.elixirmedical.com.
Source: Elixir Medical
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