Competition may come at last to the U.S. market for cardiac stents, the tiny devices that have wrought medical miracles but rocked hospitals' cardiology budgets in the past three years.
Medtronic late last month became the third company able to market a cardiac stent in the U.S. when the Food and Drug Administration approved its new Wiktor device.
But the eagerly anticipated decline in the price of stents, which typically sell for more than $1,600 each, still may be some months off, when other companies are expected to enter the market. Analysts say Medtronic will charge only slightly less for its stent than market leader Johnson & Johnson.
Yet market watchers say Medtronic's entry signals the beginning of the inevitable end of Johnson & Johnson's lock on the U.S. market. Ultimately that should spell lower prices for hospitals and more choices for cardiologists, who are hungering to supplement their clinical toolboxes with a variety of stents.
For all the big noise about cardiac stents, the slender, metal-mesh tubes are quite small-generally less than one-inch long and one-quarter inch in diameter when fully expanded.
A cardiologist threads a balloon catheter, which carries a compressed stent on its tip, through the twists and turns of a heart patient's clogged artery. When the stent reaches the plaque blocking the vessel, the cardiologist inflates the balloon, expanding the stent and compressing the plaque against the vessel wall. The expanded stent then is left behind to keep the vessel open.
Until now, the estimated $750 million annual U.S. market was left to just two companies, New Brunswick, N.J.-based Johnson & Johnson and Bloomington, Ind.-based Cook.
Although Cook narrowly beat Johnson & Johnson to market with the first stent in 1994, the hearts and minds of U.S. cardiologists belong to Johnson & Johnson. Its Palmaz-Schatz stent dominates interventional cardiology suites with almost 95% of annual stent sales, according to industry statistics.
Cardiologists say the Cook stent is usable only as an emergency measure when a vessel collapses during a procedure.
There's no question Johnson & Johnson's stent is effective in keeping coronary arteries from re-closing after angioplasty, which had been a problem in roughly half of all cases. With stents, the vessel reclosure rate drops to about 20%.
That dramatic improvement sent stent sales climbing by nearly 50% a year since their 1994 introduction. Cardiologists now use stents in about two-thirds of angioplasties, according to industry statistics.
But at a price typically in excess of $1,600, the innovation hasn't been cheap.
Despite the approval of Medtronic's stent, pricing is unlikely to drop dramatically until next year, when other companies start a dogfight for market share, analysts say. Stents made by Arterial Vascular Engineering, Boston Scientific Corp. and Guidant Corp. are expected to receive FDA marketing approval over the next year.
Eager for better gadgets, cardiologists are welcoming Medtronic's stent and the upcoming entries of other competitors.
"Now we're going to have more than one way to take care of a problem," says Richard Heuser, M.D., a cardiologist at 295-bed Columbia Medical Center-Phoenix. Heuser was involved in clinical tests of many of the new stents, including Medtronic's.
Medtronic's stent, while not as advanced as competitors' in the pipeline, is flexible and sports advantages that should win over some cardiologists right away, says Jonathan Osgood, a healthcare analyst at Alex. Brown & Sons in Boston.
"The Wiktor is not a great stent, but a good stent, and it will garner some significant sales," Osgood says. He estimates Medtronic will sell about $45 million worth of Wiktor stents in the U.S. through next April.
Despite the rising challenges to its U.S. franchise, Johnson & Johnson says it will remain "very competitive." The company is awaiting FDA approval of a second-generation stent, known as the Palmaz-Schatz Crown, which is easier to use than its current model.
But in markets abroad, Johnson & Johnson is feeling heat as newer, more flexible stents-soon to receive U.S. marketing approval-overtake the Palmaz-Schatz, analysts say.
Without product superiority, Johnson & Johnson may play its patent card to protect its market share here, observers say. It holds U.S. patents that cover various methods for placing stents inside coronary vessels.
"I would be shocked if Johnson & Johnson didn't serve Medtronic with a lawsuit," Osgood says. "We're assuming that Johnson & Johnson won't lie around and let these guys steamroll (it)."
Alternatively, or perhaps in combination with litigation, Johnson & Johnson could seek royalty payments instead, as it did successfully in action against Cook.
If Johnson & Johnson aggressively seeks to keep other companies out of the U.S. market, however, the strategy could backfire, spoiling relationships with top cardiologists.
"It would upset us a lot, quite frankly, if the ability to use what's right for an individual patient is superseded by patent issues," Columbia's Heuser says.