FDA clears Abbott?s drug-eluting stent as fourth to enter U.S. market

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Xience V from Abbott Vascular nets FDA approval. Source: Abbott Laboratories  

The FDA today approved Abbott’s Xience V everolimus-eluting coronary stent system for the treatment of coronary artery disease.

Abbott’s drug-eluting stent (DES) is the fourth on the U.S. market after Cordis’ Cypher sirolimus-eluting stent, Boston Scientific’s Taxus paclitaxel-eluting stent, and Medtronic’s Endeavor zotarolimus-eluting stent. Endeavor just gained approval in February after a more than three-year hiatus of DES approvals.

Simultaneously, Boston Scientific also receives FDA approval for its Promus everolimus-eluting coronary stent system for the treatment of coronary artery disease. Promus is a private-labeled Xience V manufactured by Abbott and distributed by Boston Scientific, under an agreement executed prior to the 2006 acquisition of the former Guidant by Boston Scientific. Boston Scientific said it will launch the Promus stent immediately in the U.S.

Xience V has demonstrated superiority over Boston Scientific's Taxus paclitaxel-eluting coronary stent system in two randomized head-to-head clinical trials, Abbott noted.

The company said that the clinical program for Xience V includes long-term data from a total of 1,362 patients enrolled in the SPIRIT I, SPIRIT II and SPIRIT III trials, as well as continued access and post-approval programs that will enroll more than 14,000 Xience V patients.

“Xience V was designed to improve safety and efficacy compared to earlier generation stents. The long-term clinical data from two studies performed in both the United States and Europe have now confirmed that Xience V is a true next-generation drug eluting stent with clinically important benefits for patients," said Gregg W. Stone, MD, Columbia University Medical Center in New York City; chairman of the Cardiovascular Research Foundation in New York City; and principal investigator of the SPIRIT III U.S. pivotal clinical trial for Xience V.

The Abbott Park, Ill.-based company said that Xience V will be launched in the U.S. immediately.