The United States has a global reputation as high-tech heaven, but when it comes to putting the latest medical gadgets into action, Europe leads the way.
That's because winning approval from the U.S. Food and Drug Administration for breakthrough medical devices typically takes years, compared with the months needed to secure the blessing of European regulators. As a result, European clinicians often are first to reap the rewards of American innovation.
U.S. medical devicemakers stand among the country's most creative companies-and most powerful exporters. In 1996 the U.S. medical device industry posted a $5.1 billion trade surplus worldwide and had total sales of $44 billion, according to the U.S. Commerce Department.
"It's a little bothersome that (overseas) you are working with higher-tech equipment-invented in the U.S.-that we can't use here without it taking a long time" for approval, says Richard Heuser, M.D., an interventional cardiologist at Columbia Medical Center-Phoenix (Arizona).
Heuser, in demand as a lecturer worldwide, frequently has the chance to implant the latest coronary stents while he's in clinics outside the U.S. Cardiologists use stents, slender metal tubes, as permanent scaffolds to prop open clogged coronary blood vessels cleared by angioplasty.
Typically, European doctors get the most sophisticated devices, such as stents, years before their American counterparts. For instance, last month the FDA approved a stent made by Guidant Corp. of Indianapolis, Indiana, only after the company completed a multiyear clinical trial involving more than 1,300 patients. Japanese authorities, also sticklers, gave the stent the green light in June. In contrast, the Guidant stent has been available in Europe since November 1995.
The key factor behind the technology gap is the immense height of the regulatory barriers to entry in the U.S. vs. the European Community. The domestic lag stems largely from the FDA's requirement that products be proved effective and safe. Conducting the necessary clinical studies is time-consuming and expensive.
Agency supporters, including Heuser to an extent, say some delay is the inevitable price of close product scrutiny that protects Americans from shoddy devices.
Critics, including the Republican-controlled U.S. Congress, say the FDA could greatly speed approvals without endangering U.S. consumers. In fact, they argue, restricting access to worthy devices may pose a greater risk to public health. Recently passed legislation could streamline FDA approvals somewhat but not enough to significantly close the approval gap with Europe, most observers agree.
For the most part, European authorities stick to judgments about device safety and manufacturing quality and leave effectiveness decisions to clinicians' choice. Doctors won't use a device that's ineffective for long, the reasoning goes.
A European governmental review, conducted by one country but valid throughout the EC, is usually completed in a matter of months and requires little clinical data.
The U.S. approval lag also affects European companies trying to export to America, still the largest device market. But at least one European manufacturer has a philosophical take on the disparity.
"In the U.S. you're more oriented toward the safety of the patients, whereas Europeans are more oriented toward the innovation of the device," says Eric Simon, president and chief executive of EDAP-TMS, a Paris-based maker of minimally invasive devices for treating urological disease.
In Europe, Simon adds, patients are less likely to sue if something goes wrong and are also more comfortable with clinical risks. Those differences are expressed in the different regulatory approaches, he says.
As long as the approval gap persists, American clinicians and healthcare administrators can only gaze longingly at Europe as a window to the future.
"A purchasing agent could look at what our next generation products are . . . and see how they're really working," says John Miller, chief financial officer at Arterial Vascular Engineering, a Santa Rosa, California-based maker of stents.
Since it went to market in 1994, the company has sold more than 160,000 coronary stents-all outside the U.S. In Europe, Arterial Vascular Engineering claims a 30% share of the nearly $550 million market, placing it at the top of the fractious heap of stent firms, according to the company and some analysts. In contrast, only 330 U.S. patients have had Arterial's stents implanted, Miller says. Those few were part of the company's clinical studies to support an application filed with the FDA in August.
Until recently, U.S. interventional cardiologists have been in the grip of Johnson & Johnson, whose Palmaz-Schatz stent got FDA approval in 1994 and has dominated the U.S. with 90%-plus market share.
That wasn't difficult because until this summer Johnson & Johnson, New Brunswick, New Jersey, had a domestic duopoly with Cook Group, Bloomington, Indiana, whose stent has limited FDA approval and has garnered only modest clinical interest.
But in the past few months, two other U.S. heavyweights have broken into their home market. Minneapolis, Minnesota-based Medtronic in June and Guidant in October won FDA approval for stents they have sold in Europe for years.
Now industry observers predict the reversal of Johnson & Johnson's stent fortunes in Europe will be replayed on the U.S. stage. On the Continent, Johnson & Johnson's stent share has fallen from No. 1 to No. 4 or No. 5, analysts report.
"Stents are a great example of a market that developed much more rapidly in Europe than the U.S. and is clearly a preview of the kinds of technology U.S. clinicians will be interested in," says Rick Wise, a medical technology analyst at Bear, Stearns & Co., a New York investment bank.
"Clinical practice with stents in Europe is one year to two years ahead of the U.S.," Wise wrote in a recent report.
The lingering gap has created stent envy among U.S. physicians, who only now are poised to get access to the devices they've heard about for years. "U.S. doctors," Wise says, "are thirsting after them."