Healthcare titan Abbott (NYSE:ABT) today announced Japanese regulatory approval for its next-generation portfolio of Xience Xpedition drug-eluting stents.
The Xience Xpedition line landed Japanese approval for treatment of coronary artery disease, the most common type of heart disease and one of the leading causes of death in Japan, according to an Abbott press release.
"The Xience family of drug eluting stents has been extensively studied in Japanese patients, including 5 Abbott-sponsored trials involving more than 3,000 patients as well as several investigator-initiated trials that have been conducted since the original launch of XIENCE V in Japan in 2010 – making Abbott’s market-leading Xience family of stents one of the most studied drug eluting stents in Japan," Abbott global public affairs director Steve Kelly told MassDevice.com in an email today.
The Xpedition line features a new stent delivery system as well as the broadest size matrix in the Japanese market, Abbott noted. The device also includes a specialized balloon that helps physicians open blockages and fit the stent into the blood vessel.
"The approval of Xience Xpedition in Japan is a significant milestone in the global expansion of Abbott’s leading next-generation drug eluting stent system, continuing Abbott’s long history of stent innovation for the benefit of patients around the world," vascular senior vice president Chuck Foltz said in prepared remarks. "With the growing prevalence of heart disease in Japan, Abbott is pleased to offer physicians an additional treatment option that is backed by the strong clinical outcomes and unique design advantages of the market-leading Xience family of drug eluting stents."
The Japan win is the latest in a series of milestones for Abbott’s Xience Xpedition line, including European CE Mark approval for the Xience Xpedition 48 (which Abbott at the time called the "world’s longest" coronary drug-eluting stent) and FDA approval in January 2013.
