Healthcare Industry News:  drug-eluting stent 

Devices Interventional Cardiology

 News Release - April 1, 2008

Elixir Medical Announces Positive Nine-Month Results From the Excella Novolimus-Eluting Coronary Stent System First-In-Man Study

Lower Drug and Polymer Formulation DES Continues to Demonstrate Excellent Clinical Safety and Efficacy Outcomes

CHICAGO & SUNNYVALE, Calif.--(HSMN NewsFeed)--Positive nine-month results from the Elixir Medical Excella™ I Trial were presented Monday at the 57th Annual Scientific Sessions of the American College of Cardiology (ACC) in Chicago by Alexandre Abizaid, M.D., PhD., FACC, Chief of Coronary Interventions at the Institute of Dante Pazzanese de Cardiologia in São Paulo, Brazil. The Excella I Trial is a fifteen patient first-in-man study of the Elixir Medical Excella Novolimus™-Eluting Coronary Stent System.

The four-month positive results from the study were presented last October at the 19th Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. 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.

“These excellent clinical results suggest that Excella may represent the next generation in drug-eluting stents by achieving the optimal clinical results using a lower drug dose and polymer load as compared to other currently available DES systems,” said Professor Abizaid.

“We believe the Excella Novolimus-Eluting Coronary Stent System will set the industry standard in achieving excellent clinical outcomes for patients,” said Motasim Sirhan, Chief Executive Officer, Elixir Medical Corporation.

Based on these sustained positive clinical results, Elixir Medical plans to initiate Excella II, a large randomized trial that will recruit patients from Europe, New Zealand, and Brazil, and will compare the Excella stent to a currently approved drug-eluting stent.

About The Excella Novolimus-Eluting Coronary Stent System

The Excella Novolimus-Eluting Coronary Stent System is designed to provide safe and effective clinical outcomes with a substantially lower drug dose and polymer load than commercially available drug-eluting stents. Novolimus, an mTOR inhibitor, is a macrocyclic lactone with anti-proliferative and immunosuppressive properties developed specifically for drug-eluting stent applications. The Elixir Medical coronary stent is covered with a thin matrix of the Novolimus drug and a proprietary durable polymer to provide controlled drug release.

About Elixir Medical

Elixir Medical Corporation develops innovative drug-eluting stent platforms for the treatment of cardiovascular disease. The company is developing a complete family of drug-eluting stent systems, with durable and bioabsorbable polymer release technologies and fully bioabsorbable stent platforms. Privately held, Elixir Medical is based in Sunnyvale, Calif. For more information, visit www.elixirmedical.com.


Source: Elixir Medical

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