They're here! After years of testing and development, a new wave of high-tech coronary stents is hitting the U.S. market.
For administrators, doctors and patients, it's not a moment too soon.
Johnson & Johnson, stent champion since 1992, began 1997 with a market share of nearly 90% and the pricing power to match. The New Brunswick, N.J.-based company routinely charged $1,595 for its standard 15-millimeter-long stent.
But new competition has shattered Johnson & Johnson's hammerlock on the market. And pricing, although slow to budge, is expected to fall significantly. That's a good thing for hospitals, given how commonplace stents have become.
Nationally, more than half of angioplasty patients have stents put in their arteries. The thin metal scaffolds prop open once-clogged arteries and virtually eliminate the sudden, life-threatening closing of vessels that occurs in 5% to 10% of balloon angioplasty cases. What's more, stents cut the reclosure of cleared blood vessels over the longer haul by half -- to 10% to 15% of cases with stents from 30% to 40% of those without, says James Hermiller, M.D., an interventional cardiologist who practices at the Indiana Heart Institute, St. Vincent Hospitals and Health Services, Indianapolis.
The emerging cornucopia of stents will only make them more attractive to doctors. Hermiller predicts routine practice eventually will mean between 70% and 80% of angioplasty patients will have the metal scaffolds left inside their arteries.
One reason is that the latest stents are sleeker and more flexible, making them easier to implant.
Even early doubters agree that stenting, despite its costs, is here to stay.
The biggest change in the stent market came in October, when Indianapolis-based Guidant Corp. received Food and Drug Administration approval for its Multi-Link stent, a hot seller in Europe for the past two years. While Guidant won't report sales figures until next month, industry analysts estimate it sold stents worth at least $90 million during the fourth quarter and claimed half the U.S. market, supplanting Johnson & Johnson as market leader.
Guidant's roaring market victory won't go unchallenged. Just before Christmas, the FDA approved an improved stent made by Johnson & Johnson, and Arterial Vascular Engineering, Santa Rosa, Calif., won approval for two stents long available in Europe.
Stents probably will stay expensive a bit longer as new competitors seek to cash in under the lofty price umbrella established by Johnson & Johnson. Guidant, for instance, has a list price of $1,525 for its 15-millimeter-long stents and $2,295 for the 25-millimeter-long model.
"It's inevitable that pricing will have to come down," says Daniel Chai, M.D., an analyst with Furman Selz in New York. But Chai says prices won't start dropping until late this year or early 1999.