CE Mark for novolimus eluting coronary stent system
Published date : 07 September 2012
Article date : 05 September 2012
A report states that Elixir Medical has gained CE Mark approval for the DESyne BD novolimus eluting coronary stent system for the treatment of coronary artery disease.
According to the manufacturer, the device has an ultrathin (< 3 microns) biodegradable, polylactide-based polymer coating that does not need an underlying primer layer. Apparently, Elixir's therapeutic compound, Novolimus, is delivered via the polylactide-based polymer to the coronary vessel wall and degrades within 6 to 9 months, leaving behind the cobalt chromium alloy metal stent surface.
The article says that during a trial, the Elixir DESyne BD novolimus eluting coronary stent system was compared with the control Endeavor Zotarolimus eluting coronary stent system. The former demonstrated superiority over the Endeavor stent for the primary endpoint of in-stent late lumen loss at six months. There was also a statistical difference in favour of DESyne BD for the secondary end point of binary restenosis.
The manufacturer reports that the device will be made available in a broad range of sizes.
Source: medicaldevice-network.com, 30 August 2012
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