Elixir Medical Corporation Announces Outstanding Three-Year Data from the EXCELLA II Randomized Clinical Trial for the CE Mark-Approved DESyne® System
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.”
About the EXCELLA II Clinical Trial
The EXCELLA II trial is a multicenter, randomized, single blind, evaluation of the Elixir DESyne Novolimus Eluting Coronary Stent System compared to the control Endeavor Zotarolimus Eluting Coronary Stent System. The study was designed to enroll 210 patients from Europe, Australia, New Zealand and Brazil. The primary endpoint was in-stent late lumen loss assessed by quantitative coronary angiography (QCA) at nine months. Secondary endpoints of the study include: device-orientated composite endpoints and stent thrombosis rates at 30 days; 6, 9, 12 months, and yearly thereafter through 5 years. A subset of patients underwent intravascular ultrasound (IVUS) evaluation at 9 months.
At 9 months, the Elixir DESyne Stent demonstrated non-inferiority and superiority (p<0.001) to the Endeavor stent for the primary endpoint of in-stent late lumen loss (0.11 ± 0.32 and 0.63 ± 0.42 respectively). In a subset of patients who underwent intravascular ultrasound (IVUS), the Elixir DESyne Stent demonstrated a statistically significant reduction in neointimal inhibition with a percentage volume obstruction of 4.5% ± 5.1 compared to 20.9% ± 11.3 for the Endeavor Stent (p <0.001). Clinical events measured using the device oriented composite endpoint (DoCE) were lower for the DESyne stent compared to the Endeavor stent (2.9% and 5.6% respectively).
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 and bioresorbable scaffold systems are designed to optimize local drug delivery to provide a safe and effective treatment for cardiovascular disease. For more information about the company, its products and clinical data, please visit http://www.elixirmedical.com.
Vinayak Bhat, Ph.D., 408-636-2006