|Abbott picked up Japanese approval for its Xience Xpedition drug-eluting stent.--Courtesy of Abbott|
Abbott Laboratories ($ABT) won Japanese approval for its Xience Xpedition drug-eluting stent, plotting to launch the device in one of the world's largest markets and pad sales in its flagging vascular business.
Japan's Ministry of Health, Labor and Welfare approved the device to treat coronary artery disease based on data from more than 3,000 Japanese patients, giving Abbott the green light to sell a stent the company said has a lower profile and wider range of sizes than anything else on the market.
"The approval of Xience Xpedition in Japan is a significant milestone in the global expansion of Abbott's leading next-generation drug-eluting stent system, continuing Abbott's long history of stent innovation for the benefit of patients around the world," Abbott Vascular Senior Vice President Chuck Foltz said in a statement.
Xpedition won FDA approval in January, and Abbott is counting on the everolimus-eluting stent to compensate for sluggish sales from its older Xience devices, the Prime and V. Since splitting off from its proprietary pharma business at the start of the year, Abbott has struggled with its stents, watching the demand for legacy products dwindle. Last quarter, vascular sales dropped 7.7% total and 19.3% in the U.S. alone.
But the company sees a way forward, and Japan plays a role in CEO Miles White's planned vascular turnaround. Last month, Abbott launched a Japanese pivotal trial for Absorb, its dissolvable vascular scaffold, hoping to duplicate the device's worldwide success since winning a CE mark last year.
In the U.S., the company is working its way through an Absorb study on 2,250 patients, aiming to snag FDA approval and beat out competitors like Boston Scientific ($BSX) and Elixir Medical, cashing in on stateside demand for dissolving implants.
- read the announcement
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