Abbott (NYSE:ABT) won approval from the Japanese Ministry of Health, Labor and Welfare for its Xience V drug-eluting stent.
Abbott said it plans to bring the device to market as soon as it receives final reimbursement authorization from Japanese officials.
The Chicago-based medical device and pharmaceuticals giant also touted the publication of the results from the Compare clinical trial demonstrating that the Xience V everolimus-eluting stent is superior to Boston Scientific Corp.’s (NYSE:BSX) Taxus line of paclitaxel-eluting stents. The study results were first released at the Transcatheter Cardiovascular Therapeutics conference in San Francisco last September.
The Compare trial, published Jan. 8 in the Lancet, was a randomized, single-center trial examining the Taxus and Xience stents in 1,800 “real-world” patients (rather than patients enrolled in clinical trials). Its primary endpoint was all-cause death, myocardial infarction (heart attack) or target vessel revascularization one year after implantation. The trial showed that patients implanted with the Xience device had a nearly 3 percent lower risk of death, MI or revascularization and a 3.3 percent lower risk for the secondary endpoint, cardiac death, non-fatal MI and target lesion revascularization.
But the news wasn’t all bad for Boston Scientific. That’s because the Xience approval in Japan means it’s cleared to sell its private-labeled Promus version of the device in the second-largest coronary stent market in the world. BSX said it too would put the Promus on the market as soon as reimbursement is approved.
Boston Scientific also said it plans to press on with its beleagered Taxus line, despite a raft of studies demonstrating that it’s less effective than competing devices like the Xience and Medtronic’s (NYSE:MDT) Endeavor zotarolimus‐eluting stent.
Taxus sales have swooned since 2006, as evidenced by declines in the royalties BSX pays to Angiotech Pharmaceuticals Inc. (the company that makes the drug, paclitaxel, used to coat the Taxus) and Boston Scientific’s own earnings reports.