US-based medical devices developer Elixir Medical has announced that the results of its CE Mark-approved DESyne BD Novolimus Eluting Coronary Stent System with biodegradable polymer coating were outstanding.
Its CE Mark-approved DESyne BD Novolimus Eluting Coronary Stent System with biodegradable polymer coating were compared to the control Endeavor Zotarolimus Eluting Coronary Stent System with durable coating in the EXCELLA BD randomized clinical trial at the two-year endpoint.
The device-oriented composite endpoints (DoCE), a measure of major adverse events (MACE), for Elixir’s DESyne were minimum and unchanged from six months through two years (2.7%).
Clinically-indicated Target Lesion revascularization (TLR) rates also remained unchanged and less in favor of the DESyne BD Stent as compared to the control (1.8% vs. 3.2%).
Further, there were no reported stent thrombosis events with DESyne BD during the period.
The Elixir DESyne BD stent uses a proprietary technology that allows an ultrathin (< 3 microns) biodegradable polymer coating without the need of an underlying primer layer.
The biodegradable, polylactide-based polymer, which allows sustained release of Elixir’s novel m-tor inhibitor, Novolimus, to the coronary vessel wall, degrades within six to nine months, leaving behind the metal stent surface achieving sustained clinical outcomes.
The randomized, controlled EXCELLA BD trial had enrolled patients in Europe and Brazil. The trial had already shown 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 six months.
Elixir Medical CEO Motasim Sirhan said that the degradable coating technology of DESyne BD has demonstrated a remarkably low MACE rate at two years compared with durable polymer platforms.
"With the DESyne BD System, Elixir continues to meet physician needs for excellent and sustained clinical outcomes," Sirhan added.