Results Set a High Standard in Sustained Long Term Clinical Outcomes 

SUNNYVALE, Calif. -- Elixir Medical Corporation, a developer of products that combine state-of-the-art medical devices with advanced pharmaceuticals, announced today excellent long-term results of its CE Mark-approved DESyne Novolimus Eluting Coronary Stent System compared to the control Endeavor Zotarolimus Eluting Coronary Stent System in the EXCELLA II randomized clinical trial at the 3 year endpoint.

At 3 years, device-oriented composite endpoints (DoCE), a measure of major adverse events, for Elixir’s DESyne were exceptionally low and essentially unchanged through 1, 2 and 3 years (4.3%, 4.3% and 5.0%) while the control Endeavor increased yearly (7.0%, 9.9% and 12.7%) with a trend towards statistical significance (p=0.057). Target Lesion revascularization (TLR) rates at 3 years were significantly lower in favour of the DESyne Stent as compared to the control (1.4% vs. 9.9%; p=0.008).

Elixir’s DESyne Stent elutes the novel m-tor inhibitor compound Novolimus. It is the first drug eluting stent to successfully combine the thinnest durable polymer coating, the lowest drug dose, and thin stent struts to achieve excellent clinical outcomes as compared to other commercially available drug eluting stent systems. The EXCELLA II Trial had previously demonstrated both non-inferiority and superiority of DESyne compared to Endeavor for the primary endpoint of in-stent late lumen loss at 9 months.

"The excellent and sustained clinical outcomes over three years clearly distinguish DESyne from other commercially available DES, which typically exhibit deterioration of clinical outcomes over time," said Joachim Schofer, MD, Universitares Herz- und GefaBzentrum, Hamburg, Germany. "DESyne is a strong next generation product for physicians seeking to further improve patient outcomes."

"We are excited that DESyne’s excellent three-year results from EXCELLA II set a high industry standard among leading DES systems for maintaining outstanding long term clinical outcomes," said Motasim Sirhan, Chief Executive Officer of Elixir Medical. "Elixir’s Novolimus-eluting broad product portfolio has been designed to deliver outstanding acute and long terms clinical outcomes."

Source: Elixir Medical Corporation