Tests keep Temecula stent factory busy

Jun 17, 2009 (The Press-Enterprise - McClatchy-Tribune Information Services via COMTEX) -- ABT | Quote | Chart | News | PowerRating -- Abbott Laboratories, whose drug-coated heart stent, Xience V, captured a strong following among doctors within months of hitting the market last year, has started testing its follow-up product.

The company, which manufactures stents in a factory in Temecula, said in a statement Tuesday it is beginning clinical trials of Xience Prime. The new stent, which may be three years away from coming to market, is one of two being tested by the Abbott Park, Ill.-based company.

The two stents in the pipeline could keep employees at its Temecula facility busy well into the next decade. The factory, one of the largest manufacturing facilities in Inland Southern California, employs about 4,000 people and is the only plant that makes Abbott's stents in North America.

Stents are tiny, wire-mesh tubes that are inserted into blood vessels, usually through an incision made in the abdomen.

They are designed to keep clogged blood vessels open, usually following an angioplasty procedure, and are coated with drugs and polymers to prevent blood clots and reduce inflammation.

Along with Xience Prime, Abbott is developing a stent that dissolves in blood vessels over time, said Jonathon Hamilton, senior director of public affairs for Abbott Vascular. That product will start its second phase of testing in March, he said.

Xience V and Promus, the Abbott-developed stent being marketed by Boston Scientific, have combined to capture more than half the United States market since it was introduced last summer, company officials told analysts during their most recent earnings conference call in April.

At that conference call, RBC Capital Markets analyst Glenn Navarro asked why Xience V sales seemed to have leveled off in the first two months of this year. Miles White, Abbott's chief executive, said it was likely because a new stent, Taxus Liberte, came to market.

Doctors have said Abbott's stents are easier to implant than competitors', and Hamilton said Xience Prime is designed to use that advantage.

"If you can make a more deliverable stent that you can get smoothly to where the lesion is, doctors are going to like it," Hamilton said. "We're always studying ways to make it thinner and more deliverable."

The clinical trials will involve some 500 patients willing to carry an experimental stent in their circulatory system.

Hamilton said these patients first have to be recruited, then monitored for a long period of time before the stent can be brought to the U.S. Food and Drug Administration for approval.

That is why Abbott is unclear when Xience Prime can be sold in the United States, but Hamilton said the best guess now is the first half of 2012.

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