Sunnyvale, CA-based Elixir Medical has received the CE Mark for its DESyne drug-eluting coronary stent system for the treatment of coronary artery disease. The company plans to launch the DESyne product platform in Q3 with a broad size matrix of diameters ranging from 2.5 to 3.5mm and lengths ranging from 8 to 28mm, according to a company release.
Elixir, which was founded in 2005, is developing a range of drug and device platforms for vascular therapies. The DESyne stent elutes a novel macrocyclic lactone compound Novolimus, a metabolite of sirolimus that was developed internally by Elixir. The company also has a co-exclusive license to Myolimus from Novartis Pharma AG that grants Elixir worldwide rights to use the compound with its vascular and other site-specific drug-delivery applications. In addition, Elixir has an exclusive worldwide license for use of Myolimus in fully biodegradable stents.
Results from the EXCELLA II trial comparing the DESyne Novolimus system with Medtronic's Endeavor Zotarolimus-eluting coronary stent system demonstrated DESyne's superiority in the study's primary endpoint of in-stent late lumen loss. Elixir's stent also demonstrated a statistically significant reduction in neointimal inhibition as well as restenosis, according to a company release.
Company CEO Motasim Sirhan told FierceMedicalDevices he excited about the DESyne system because it is as effective and safe as other commercially available products. Furthermore, it uses about half the drug dose of its competitors and has a thin polymer coating. The system isn't available in the U.S., but the company is working toward entering the market, Sirhan told FMD.
Sirhan also stressed that even though is relatively small, it has a broad portfolio compared with its competitors, as well as the ability to address the needs of patients.
- get the Elixir release