Japanese regulators have signed off on Abbott Labs' ($ABT) next-generation Xience Prime drug-eluting coronary stent, granting approval for its use to treat clogged arteries.
And with that regulatory sign-off, Xience Prime has approval in the world's second largest healthcare market. The world's largest is the U.S., and Abbott gained FDA approval for the everolimus-eluting stent in November. As with its attempt to get the FDA's blessing, the company used data from its global SPIRIT PRIME trial with its submission to the Japanese Ministry of Health, Labor and Welfare. Abbott tested the stent in 500 coronary artery disease patients at multiple centers in the U.S. and Australia, meeting its primary endpoint of low rates of target lesion failure at one year. Testing also produced low rates of stent-related blood clots.
Investors were mixed on the news in early trading Monday, with Abbott's stock at $60.74, down less than 1%.
The company touts the stent's predecessor Xience V as "the market leading drug-eluting stent in Japan and globally." Xience Prime keeps some of its predecessor's features, but it is more nimble and has the ability to reach difficult clots (it has longer lengths to treat long lesions), according to the company. Xience Prime is already approved in Europe, China and India, as well as other Asian and Latin American countries, Abbott notes.
Device companies are aggressively developing new drug-eluting stent products. However, a recent study suggested that drug therapy could work just as well for stable patients who have narrowed heart arteries.
- here's the release