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The company is planning for an immediate launch of the Xpedition with the approval in hand. The product gained CE Mark approval in Europe several months ago, and Abbott relied on similar data that won that recognition -- data compiled from 100 studies and thousands of patients -- to gain the FDA thumbs up.
Abbott's executive vice president of Medical Devices, Dr. John Capek, explained the Xpedition's role in the company's future in the release, saying:
The launch of XIENCE Xpedition in the United States will advance Abbott's worldwide market-leading position in drug eluting stents. ... With its redesigned stent delivery system and a full matrix of sizes, XIENCE Xpedition provides physicians with a comprehensive, trusted option to treat a broad range of patients with coronary artery disease.
The approval marks the first regulatory victory for Abbott since the company completed the spinoff of its pharmaceuticals business on Jan. 1.