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
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
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
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
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
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
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