After receiving CE mark approval for its Xlimus drug-eluting stent, Cardionovum has initiated the international (outside of the USA) market launch of the stent. The stent is coated with the antiproliferative drug sirolimus and uses a fully biodegradable PLLA (Polylactid) drug release matrix.
A press release reports that Xlimus provides an outstanding tracking and lesion crossing performance quality, which ensures treatment of complex coronary artery lesions. It also states that early clinical results from a first-in-man study (39 patients) show that Xlimus implantation was successful in 100% of the treated patients (mean age of 68 years, 72% men, 27% diabetic patients, 64% had multivessel disease, 14 patients had complex lesions B2-C) and that direct stenting was performed in 90% of the patients. At the six-month follow-up point, there were no major adverse cardiovascular events (MACE) and no reports of target lesion revascularisations.
According to Carlo Briguori (chief cardiologist of the Clinica Mediterranea, Naples, Italy), thanks to Xlimus’s superior performance quality, total occlusions can be treated with the highest probable rate of success with the stent. Briguiori also reports experiencing an excellent even stent expansion during stent deployment.
The Xlimus stent struts are 73µm thin, which reduces the metal volume implanted. The stent platform is made of cobalt chromium L 605 and the stent is available in a 6-, 8-, or 10-cell structure design. The 6-cell design is for stenting of coronary artery diameter of 2.25mm-2.50mm, 8-cell structure is used for stenting of 2.75-3.50mm artery diameters, and the 10-cell is for larger artery diameter lesions (up to 5mm).
Xlimus provides a biodegradable PLLA polymer, which elutes the antiproliferative drug sirolimus up to 90 days. After complete drug elution, the biodegradable polymer has gone and the thin stent struts are left behind.