TRENTON, N.J. (AP) - Demand for Johnson & Johnson's new drug-coated stents has greatly eclipsed supply in the two months they've been on the U.S. market, boosted by pent-up demand from surgeries postponed until the devices gained regulatory approval.
The drug coating on the stents reduces chances a heart artery will reclog after being cleared out and propped open with the tiny metal scaffolds.
A report of two deaths in patients who received the stent briefly shook the company's stock Friday. The Food and Drug Administration is looking into the deaths at St. Francis Hospital in Roslyn, N.Y., in two patients who they developed blood clots around Cypher stents, said spokeswoman Kathleen Quinn.
The hospital said incidence of clot formation in the 264 patients it has given Cypher stents appears similar to the rate with bare metal stents. Hospital spokesman Andy Kraus would give no further information.
Sam Liang, vice president of the global stent business at Johnson & Johnson's Cordis Corp. unit in Miami Lakes, Fla., said the patients were elderly and extremely sick, and the problem was not with the stent.
The news pushed J&J stock down as much as 3 percent on the New York Stock Exchange, but it recovered to close at $51.54, down about 1.5 percent.
For now, Cordis has the drug-coated stent market to itself, said Dan Lemaitre, medical technology analyst at Merrill Lynch, who recommended investors buy the stock on the dip.
Hospitals have been complaining about a shortage of Cypher stents, which slowly release medicine to prevent scarring around the stent from reclogging an artery cleared out by angioplasty - a condition called restenosis. Roughly 15 percent of patients with bare metal stents must undergo another artery-clearing procedure within a year; with Cypher, the rate is about 4 percent, according to Cordis, the stent-making unit of New Brunswick, N.J.-based Johnson & Johnson.
"I have a hunch in the long run that's all we're going to be using," American Heart Association spokesman Dr. Donald LaVan, a cardiologist at University of Pennsylvania School of Medicine, said of the drug-coated stent.
Fueled by patient demand, doctors' enthusiasm and use in sicker patients than expected, Cordis' share of the U.S. stent market jumped from 30 percent to more than 60 percent within five weeks of Cypher's April 24 approval, Liang said. Cordis has increased manufacturing capacity about 50 percent, he added.
Robert Wood Johnson University Hospital in New Brunswick already has 35 people on a waiting list.
"People who can't wait are having a bare stent put in and others whose condition is stable enough to wait can have a Cypher stent reserved for them," said hospital spokesman John Patella.
But Cypher isn't right for every patient, said Dr. Spencer King, director of interventional cardiology at Piedmont Hospital and a professor of medicine at Emory University in Atlanta. He said unless patients have diabetes, narrow arteries or a long clogged stretch, bare metal stents are generally fine.
"Restenosis, as far as we know, doesn't alter your survival," Kings said, but many physicians feel they should use a Cypher so patients won't think the hospital was trying to save money.
Cypher stents retail for $3,195, compared to about $1,000 for bare metal ones, and while Medicare is paying nearly all of the cost, hospitals are losing some money on Cyphers, doctors say.
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