New coronary stent wins CE Mark

Published date : 25 August 2012
Article date : 22 August 2012

Abbott's Xience Xpedition coronary stent has won CE Mark approval and the company plans an immediate launch in European countreis that recognise the Mark.

The company described the device as approved to treat patients with diabetes and requiring 3 months of dual-antiplatelet drug therapy, which the company hails as the shortest duration required for any major drug eluting stent offered in Europe.

According to Abbott's press release, "Long-term compliance to DAPT can be a challenge for patients and can lead to additional safety risks such as increased bleeding events. Having a shorter DAPT duration after stent implantation may be beneficial in case a patient needs to interrupt or discontinue the medication prior to surgery or for other considerations."

Earlier this year, Abbott won regulatory approval in Japan for its Xience Prime cobalt-chromium drug-eluting stent. Now that Johnson & Johnson's Cordis subsidiary has ceded the coronary stent market to its rivals, Abbott, Boston Scientific and Medtronic are each attempting to dominate the sector. In April, data showed that Medtronic's Resolute stent proved non-inferior to Abbott's Xience in an off-label study, which included "live" uses, in patients with complex lesions.

Source: Mass Device, 20 August 2012

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