Abbott (NYSE:ABT) said its Xience Xpedition coronary stent won CE Mark approval in Europe, with an immediate launch slated for all countries that recognize the mark.
The Chicago-area medical device company said the Xience Xpedition is approved to treat patients with diabetes and requires only 3 months of dual-antiplatelet drug therapy, which Abbott touted as "the shortest duration required for any major drug eluting stent offered in Europe," according to a 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," according to the release. "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."
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In April, Abbott won a regulatory nod in Japan when regulators there approved its Xience Prime cobalt-chromium drug-eluting stent. Now that Johnson & Johnson‘s (NYSE:JNJ) Cordis subsidiary has ceded the coronary stent market to its rivals, Abbott, Boston Scientific (NYSE:BSX) and Medtronic (NYSE:MDT) are locked in a 3-way battle to dominate the sector.
Medtronic’s latest salvo also came in April, when it lauded data showing that its Resolute stent proved non-inferior to Abbott’s Xience in an off-label study, including "real world" uses, in patients with complex lesions.