Elixir Medical Receives European Approval for Coronary Stent System

Elixir Medical has received the CE Mark for its DESyne BD drug-eluting stent with biodegradable polymer coating. The device is indicated for the treatment of coronary artery disease.

“The CE Mark approval validates the impressive clinical results demonstrated with this stent system, including excellent efficacy and no cases of stent thrombosis through the one-year endpoint,” said Alexandre Abizaid, M.D., Ph.D., from the Instituto Dante Pazzanese de Cardiologia in Sao Paulo, Brazil. “The combined attributes of lowest polymer load, lowest drug dose, and thin stent struts provides physicians with a state-of-the-art workhorse product that raises the bar for treating patients with coronary artery disease.”

Abizaid was a co-principal investigator for the Excella BD clinical trial, the randomized clinical trial that evaluated the stent system. The study compared DESyne to the control device, Medronic’s Endeavor stent, enrolling patients in Europe and Brazil.

Elixir Medical reported that the trial demonstrated the superiority of DESyne compared with the Endeavor stent for the primary endpoint of in-stent late lumen loss. There was also a statistical difference in favor of DESyne BD for the secondary end point of binary restenosis. In a subset of patients who underwent intravascular ultrasound imaging, the findings mirrored the angiographic results demonstrating a statistically significant reduction in percent neointimal obstruction for the DESyne BD stent versus the Endeavor stent. DESyne reportedly sustained good performance at the 12-month follow up as well.

The Elixir DESyne BD stent uses a proprietary technology to enable an ultrathin (less than 3 microns) polymer coating without the need for an underlying primer layer. The biodegradable, polylactide-based polymer is designed to enable the sustained release of Elixir’s therapeutic compound, Novolimus, to the coronary vessel wall and degrades within 6 to 9 months, leaving behind the cobalt chromium alloy metal stent surface.

“The CE Mark approval for the DESyne BD system is a major milestone for Elixir,” said Motasim Sirhan, CEO of Elixir Medical. “It reinforces the excellent safety and effectiveness achieved with the CE Mark approved DESyne system, and positions Elixir as the only company to offer both durable and biodegradable polymer DES systems. Elixir remains committed to providing interventional cardiologists with the broadest and most innovative product portfolio to advance patient care. Elixir intends to launch the DESyne BD system in a broad range of sizes.”

Based in Sunnyvale, Calif., Elixir Medical develops drug-device treatment technology with a particular focus on drug-eluting stent systems.