Xience and Promus everolimus-eluting stents get FDA approval

Shelley Wood

July 03, 2008

Gaithersburg, MD - Seven months after an FDA advisory panel voted nine to one to recommend approval of the Xience V everolimus-eluting stent (Abbott Vascular), the FDA has granted marketing approval to the device. The agency's decision means that two new options will enter the US market: the Abbott Xience, as well as an identical version of the stent marketed by Boston Scientific in a profit-sharing arrangement—a legacy of the Guidant 2006 buyout. Boston Scientific's version of the stent is called the Promus.

Physicians who have been itching to get their hands on the stent say the FDA's decision is "good news" for both doctors and patients, particularly if the addition of a new stent to the market has the effect of driving down the cost of drug-eluting stents (DES) generally.

Xience V (Source: Abbott)

Together the Xience and the Promus represent the fourth DES to pass the approval process in the US, following frontrunners Cypher and Taxus in 2003 and 2004, respectively, as well as Medtronic's Endeavor stent, approved earlier this year. The Xience is the first stent to prove superior, in a randomized clinical trial, to another DES already on the market. As previously reported by heart wire , the FDA panel voted to recommend approval of the Xience on the basis of results from the SPIRIT trial program, despite having two-year follow-up data for just 422 patients and three-year data for only 26 patients.

At the EuroPCR meeting in May, however, Dr Gregg Stone (Columbia University, New York, NY) presented two-year data for the full SPIRIT II trial, showing that the gap separating MACE and target-vessel-failure (TVF) rates in patients treated with the Xience V stent vs the paclitaxel-eluting Taxus stent has continued to widen between 12 and 24 months. MACE rates were reduced by 45%, while TVF was reduced by 32%. Rates of target lesion revascularization (TLR) and stent thrombosis were also numerically lower for the Xience V stent.

Industry analysts, who had earlier predicted a Xience approval within the second quarter of 2008—an expectation narrowly missed by the company—also believe interventionalists will swiftly embrace the stent. Some have predicted that the Xience will quickly snag more than 20% of the market, while the Promus may grab an additional 20%, so that together the two stents will represent the bulk of US usage. Boston Scientific's Taxus stent, however, will likely be the biggest loser as a result of the fresh competition, analysts predict.

The approval means Abbott must pay $250 million to Boston Scientific—something that was part of the original Guidant buyout deal—but Boston Scientific will pay a royalty of 40% to Abbott for every Promus stent it sells.

Advantages over earlier DES

Commenting on the approval for heart wire , Dr Bill O'Neill (University of Miami, FL) called it "good news" for interventionalists and patients alike.

"The stent is really highly deliverable, and it comes on an RX platform, and that's going to give it, I think, an edge over the Endeavor device, which has a delivery platform that is a little different from what people are used to using," he said.

He also points out that the Abbott sales force has a long history with "most of the major cath labs," which will help fast-track the device onto cath-lab shelves.

"The other kind of interesting advantage to this stent is that you can see through the stent with CT angiography: actually, it will be the first stent on the market that will permit you to use CT angiography after implantation, if you wanted to screen for restenosis," he told heart wire .

O'Neill believes the Xience will reach 15% of the market share "relatively soon." It may also have the effect of trimming back the cost of DES generally.

"If you go back and look at the history of balloons, the price on balloons stayed very constant while there were three players, but when the fourth came out, the price dropped dramatically; the same thing happened with [bare-metal] stents. So I think there's going to be some big cost pressure, and there should be a substantial decrease in the cost of DES within the next year," O'Neill predicts.

O'Neill disclosed serving as a consultant for Medtronic.

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