Elixir Medical, a developer of product platforms combining medical devices with advanced pharmaceuticals, has presented results of Excella II randomized clinical trial comparing Elixir DESyne stent with control Endeavor stent.
Elixir Medical claimed that the Elixir DESyne Stent is the first drug eluting stent with the thinnest durable polymer coating and a low drug dose to achieve positive clinical outcomes as compared to the commercially available drug eluting stent systems. The DESyne stent elutes a macrocyclic lactone compound Novolimus.
The study was designed to enroll 210 patients in Europe, Australia, New Zealand and Brazil. At nine months, the Elixir DESyne Stent demonstrated superiority to the Endeavor stent for the primary endpoint of in-stent late lumen loss.
According to Elixir Medical, in a subset of patients who underwent intravascular ultrasound (IVUS), the Elixir DESyne Stent demonstrated a reduction in neointimal inhibition with a percentage volume obstruction of 4.5% ± 5.1 compared to 20.9% ± 11.3 for the Endeavor Stent.
In addition, the Elixir DESyne stent demonstrated a statistically significant reduction in restenosis, a re-blockage in the stent, at nine months compared to Endeavor. Clinical events measured using the device oriented composite endpoint (DoCE) were lower for the DESyne stent compared to the Endeavor stent.
Motasim Sirhan, chief executive officer of Elixir Medical, said: “The excellent results from the Excella II trial reinforces our enthusiasm for the Novolimus compound and the effectiveness of the Novolimus eluting coronary stent programs. These results also confirm that excellent clinical outcomes can be achieved with a design incorporating an ultra thin durable polymer and low drug dose.”