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® 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 2-year endpoint.
At 2 years, device-oriented composite endpoints (DoCE), a measure of major adverse events (MACE), for Elixir’s DESyne were exceptionally low and unchanged from 6 months through 2 years (2.7%). Clinically-indicated Target Lesion revascularization (TLR) rates at 2 years were also unchanged and lower in favor of the DESyne BD Stent as compared to the control (1.8% vs. 3.2%). Moreover, there were no reported stent thrombosis events with DESyne BD through 2 years.
The Elixir DESyne BD stent utilizes a proprietary technology to enable an ultrathin (< 3 microns) biodegradable polymer coating without the need for an underlying primer layer. The biodegradable, polylactide-based polymer, 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).
“I am excited about the excellent and sustained long term clinical outcomes demonstrated by DESyne BD through two years,” said Ricardo Costa, M.D., Ph.D., Instituto Dante Pazzanese de Cardiologia, Sao Paulo, Brazil, who presented these results at the EuroPCR session of “Bioresorbable vs. Durable Polymer coating for DES” in Paris earlier today. “The combined attributes of lowest bioabsorbable polymer load and drug dose, and thin stent struts provides physicians with a state-of-the-art next generation workhorse product that raises the bar for treating patients with coronary artery disease.”
“The degradable coating technology of DESyne BD has demonstrated a remarkably low MACE rate at two years compared with durable polymer platforms,” said Motasim Sirhan, Chief Executive Officer of Elixir Medical. “With the DESyne BD System, Elixir continues to meet physician needs for excellent and sustained clinical outcomes.”
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, please visit http://www.elixirmedical.com.
