Elixir Medical won CE Mark approval in the European Union for its DESyne BD drug-eluting stent with a bioabsorbable polymer coating, the company announced this week.
Elixir’s uses proprietary technology to coat the novolimus-eluting DESyne BD stent with an ultra-thin polymer coating that enables sustained drug release and degrades over 6 to 9 months, leaving behind a bare metal cobalt chromium stent.
"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," Dr. Alexandre Abizaid, lead investigator for Elixir’s Excella BD study, said in prepared remarks. "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."
At 6 months DESyne BD proved superior to Endeavor for in-stent late lumen loss and binary restenosis, according to Elixir. DESyne BD was comparable to Endeavor in terms of clinical events, and performance at 1 year remained positive.
"The CE Mark approval for the DESyne BD system is a major milestone for Elixir," CEO Motasim Sirhan said in a prepared statement. "[This] positions Elixir as the only company to offer both durable and biodegradable polymer DES systems."
The Sunnyvale, Calif.-based stent maker plans to launch the DESyne BD in Europe in a variety of sizes, Sirhan added.
Elixir earlier this year touted 1st-in-man clinical results for its DESolve fully bioabsorbable drug-eluting scaffold system, a stent made from a proprietary polymer and coated in novolimus. The entire stent is designed to be absorbed by the body in 1-2 years.