Post-split Abbott announces FDA win for Xience Xpedition stent

January 3, 2013 by MassDevice staff

Healthcare giant Abbott starts off its post-split season with an FDA win for its Xience Xpedition drug-eluting stent system.

Abbott logo

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.

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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.