Boston Scientific plans to submit a PMA for its third-generation platinum-chromium Taxus Element stent to FDA by June, relying on pivotal trial data reported March 15 at the American College of Cardiology meeting in Atlanta.

Based on that timing, the firm expects approval by the end of the second quarter of 2011, according to Jess Lemaster, Boston Scientific's VP for stent marketing.

"When Taxus Element launches here in the U.S., we believe it will be the most deliverable platform on the market," he told "The Gray Sheet" at ACC.

Researchers reported results from the PERSEUS trial, which showed the paclitaxel-eluting Taxus Element to be non-inferior to the first-generation Taxus Express paclitaxel stent and statistically superior to the Express bare-metal stent.

PERSEUS is two trials in one. In the "workhorse" component, 1,262 patients were randomized 3:1 to Taxus Element and Taxus Express. The primary endpoint of target-lesion failure at one year was statistically equivalent between the two groups (5.57% versus 6.14%, for Element and Express), as was the secondary endpoint of in-segment stenosis.

The other component of the trial compared Taxus Element to the bare-metal stent in smaller vessels, with diameters between 2.25 mm and 2.75 mm and lengths of 20 mm or less. At nine months, the drug-eluting stent exhibited in-stent late-loss of 0.38 mm versus 0.8 mm, a statistically superior result.

The study "demonstrates the successful transfer" of paclitaxel to the new platform, affirmed Dean Kereiakes, medical director at Christ Hospital Heart and Vascular Center, Cincinnati, and PERSEUS principal investigator. Compared to current stainless steel and cobalt-chromium stents, the platinum-containing Element is easier to see on an angiogram and easier to deliver, he said.

In addition to largely replacing the Taxus Express and Taxus Liberté market, Lemaster says the company will try to employ the ease-of-use argument to convert some users of Abbott's Xience ( and Boston Scientific's private-label version, Promus ) everolimus-eluting stent to the Taxus Element.

"Ease of use and acute delivery and acute performance is always something that has been important to [interventional cardiologists]," he explained.

But Xience/Promus has taken significant share from Taxus already, particularly since data showing clear advantages for the everolimus stents were reported at last year's Transcatheter Cardiovascular Therapeutics meeting (¹ Also see "Research In Brief" - Medtech Insight, 11 January, 2010.). Analysts question whether Taxus Element will have much of a market impact because of the movement away from paclitaxel.

Lemaster acknowledged that, while not universal, there is a market preference for everolimus. Promus, on Abbott's Spirit platform, is providing revenue to his firm, but the supply agreement with Abbott for the product runs out in 2012.

PERSEUS Data Offers Glimpse At Future Element

In anticipation that many physicians won't be sold on the Element deliverability argument alone, Boston Scientific sales reps plan to return to them in 2012 with Promus Element , which combines the platinum-chromium stent with everolimus.

Promus Element is available in Europe, and results from the U.S. PLATINUM trial comparing the stent to Xience/Promus are expected at the 2011 ACC meeting. FDA approval is expected by mid-2012.

Promus Element "allows us to control our own destiny with everolimus," Lemaster said.

That is why stent market watchers were primarily interested in the PERSEUS data as a first look at the platform for Promus Element.

"For Boston's purposes, the good news is that the trial raised no red flags to impact the current adoption of Promus Element in Europe or derail it from making the switch in the U.S. before its access to Promus runs out," J.P. Morgan analyst Michael Weinstein writes.

Lemaster agrees that the PERSEUS data "indirectly" benefits Promus Element. "It gives people exposure to the platinum-chromium and to the Element geometry," he said, which is an important first step, because Element will be the company's franchise stent platform for the next five to six years.

- David Filmore ( ² d.filmore@elsevier.com )

Boston Scientific Plans Taxus Element FDA Submission In Next Three Months

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