SUNNYVALE, Calif.--(BUSINESS WIRE)--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.
EXCELLA BD Randomized Clinical Trial demonstrates Outstanding Three-Year Results from the for the CE Mark-Approved DESyne® BD System with Biodegradable Polymer Coating
Elixir also announced excellent long-term results of its CE Mark-approved DESyne® BD Novolimus Eluting Coronary Stent System with biodegradable polymer coating compared to the control Endeavor Zotarolimus Eluting Coronary Stent System with durable coating in the EXCELLA BD 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 BD were exceptionally low at 5.4% as compared to the control at 6.5% (p=0.68). Clinically-indicated Target Lesion revascularization (TLR) rates at 3 years were also lower in favor of the DESyne BD Stent as compared to the control (2.7% vs. 6.5%, p=0.30). Moreover, there were no reported stent thrombosis events with DESyne BD through 3 years.
The Elixir DESyne BD stent utilizes a proprietary technology to enable an ultrathin biodegradable polymer coating without the need for an underlying primer layer. The biodegradable, polylactide-based material, which enables the sustained release of Elixir’s novel m-tor inhibitor, Novolimus, to the coronary vessel wall, degrades within 6-9 months, leaving behind the metal stent surface achieving excellent and sustained clinical outcomes. The randomized, controlled EXCELLA BD trial, which enrolled patients in Europe and Brazil, had already demonstrated both non-inferiority and superiority of the DESyne BD biodegradable polymer DES compared to the durable polymer DES control for the primary endpoint of in-stent late lumen loss at 6 months (0.12±0.15 mm vs. 0.67±0.47 mm respectively, p<0.001).
Excellent Eighteen-Month DESolve Nx Trial Results for CE mark-approved DESolve Fully Bioresorbable Novolimus Eluting Coronary Scaffold System Presented
In addition to the above results, 18-month QCA (Quantitative Coronary Angiography) follow-up in a single center subset of 20 patients from the DESolve Nx Study was also presented at EuroPCR for the first time by Alexandre Abizaid, MD, PhD, Instituto Dante Pazzanese, Sao Paulo, Brazil, and Co-Principal Investigator.
Results showed a minimal change in the in-scaffold late lumen loss (LLL) between 6 and 18 months (0.25 to 0.31 mm mean LLL; median 0.13 to 0.21 mm LLL; with a mean and median change of 0.07 mm and 0.04 mm, respectively). These data confirm sustained neointimal suppression through 18 months.
“Elixir products have become synonymous with dependable and excellent acute performance, and great long-term results,” said Motasim Sirhan, Chief Executive Officer of Elixir Medical. “With these superior clinical trial results for the CE Mark-approved DESyne Stent System and the sustained data for DESyne BD Coronary Stent Systems and the CE Mark-approved DESolve Coronary Scaffold System, Elixir is proud to provide physicians with a broad range of products in order to meet their goals of outstanding clinical outcomes for their patients.”
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.
