Upcoming Abbott Stent Review Could Hurt Taxus Market

The FDA’s Nov. 29 review of Abbott Laboratories’ Xience drug-eluting stent could spell trouble for Boston Scientific as a “successful launch of Abbott’s Xience in the U.S. will erode [Boston Scientific’s] Taxus franchise," analysts say.

Abbott’s clinical data will be presented to the Circulatory System Devices Advisory Panel, which will review the data and recommend if the FDA should approve the Xience, a next-generation drug-eluting stent for the treatment of coronary artery disease.

RBC Capital Markets analysts say briefing documents released by the FDA confirm that the Xience is superior to the Taxus on all major efficacy and safety measurements, and the analysts expect the panel to vote for approval of the stent.

Data made available as part of the panel documents include two-year safety results from a pooled subset of 603 patients from the SPIRIT II and SPIRIT III trials, Abbott said. The new two-year subset data analysis shows similar low rates of major adverse cardiac events, target vessel failure, cardiac death, heart attack and stent thrombosis as previously reported in the SPIRIT trials. The pooled data also show similar rates of death, myocardial infarction and late stent thrombosis between the Xience and the Taxus at two years.