CE Mark-Approved DESyne® Novolimus Eluting Coronary Stent System is Superior in Safety and Efficacy at the 5-year Endpoint in the EXCELLA II Randomized Clinical Trial 

Three-Year Results from the EXCELLA BD Randomized Clinical Trial for the CE Mark-Approved DESyne BD System with Biodegradable Polymer Coating Continues Reporting No Stent Thrombosis

Excellent Eighteen-Month DESolve Nx Trial Results for CE mark-approved DESolve Fully Bioresorbable Novolimus Eluting Coronary Scaffold System Confirm Sustained Neointimal Suppression

Sunnyvale, CA—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 and CE Mark-approved DESyne BD Novolimus Eluting Coronary Stent System with biodegradable polymer, both compared to the control Endeavor Zotarolimus Eluting Coronary System. Outstanding 18-month results of Elixir’s CE Mark-approved DESolve® Novolimus Eluting Bioresorbable Coronary Scaffold System were also presented at the annual EuroPCR conference in Paris.

CE Mark-Approved DESyne® Novolimus Eluting Coronary Stent System is Superior in Safety and Efficacy at the 5-year Endpoint in the EXCELLA II Randomized Clinical Trial

At the 5-year follow-up mark, the incidence of device-oriented events was significantly lower in Elixir’s CE Mark-approved DESyne Novolimus Eluting Coronary Stent System group compared to the control Endeavor Zotarolimus Eluting Coronary Stent System group in the EXCELLA II randomized clinical trial suggesting superior efficacy and safety of Elixir’s system.

Device-oriented composite endpoints (DoCE), a measure of major adverse events, for Elixir’s DESyne were exceptionally low through 1, 2, 3 and 5 years (4.3%, 4.3%, 5.0% and 7.9%) while the control Endeavor increased yearly (7.0%, 9.9%, 12.7% and 19.7%) demonstrating statistical superiority (p=0.02). Target Lesion revascularization (TLR) rates at 5 years were also lower in favour of the DESyne Stent as compared to the control (2.2% vs. 8.5%; p=0.06).

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 significant superiority in long-term clinical outcomes over five years clearly distinguish Elixir’s DESyne System from other commercially available DES, which typically exhibit deterioration of clinical outcomes over time,” said Professor Patrick W. Serruys, MD, Thorax Centre, Erasmus MC, Rotterdam, Netherlands, and Principle Investigator  of the  EXCELLA II trial.

The 5-year follow-up of patients in EXCELLA II marks the completion of the EXCELLA II randomized  controlled trial. Elixir’s DESyne Novolimus Eluting Coronary Stent System is commercially available in countries in Europe, Middle-East and Asia.

Source: Elixir Medical Corporation