Abbott (NYSE:ABT) announced FDA approval for its Xience Xpedition coronary stent, planning commercial launch in the U.S. immediately.
Abbott’s Xience line of drug-eluting stents are the only such devices on the U.S. market approved for "direct stenting," in which the stent is delivered to the targeted blood vessel without a prior procedure preparing the lesion.
The Xience Xpedition everolimus-eluting stent also features the largest size matrix commercially available in the U.S., according to a press release.
"The launch of Xience Xpedition in the United States will advance Abbott’s worldwide market-leading position in drug eluting stents," Abbott medtech executive vice president John Capek said in prepared remarks. "Xience Xpedition leverages the strong clinical outcomes of Xience V and Xience Prime while providing important advantages in deliverability."
Abbott’s Xience Xpedition in August 2012 won CE Mark approval for distribution in the European Union. 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.
The new FDA win is the 1st major announcement for Abbott following its split from its proprietary drugs business, which took on a life of its own under the name AbbVie (NYSE:ABBV).
The separation was made official January 1, after the board of directors signed off on the split mid-November.