When an advisory panel on Thursday recommended that federal regulators approve a new heart stent made by Abbott Laboratories, few would initially believe the news could benefit market leader and rival Boston Scientific Corp.
But industry observers and analysts say it will.
The Food and Drug Administration (FDA) panel gave the agency the thumbs-up to approve a drug-coated heart stent called Xience, which is made by Illinois-based Abbott. The FDA usually follows panel recommendations, and Abbott hopes to begin selling Xience in the United States in mid-2008.
If Xience ultimately is approved by the FDA, a stent made by Boston Scientific called Promus also will be approved. It is, after all, the same stent.
"If two stents came off the Abbott production line, one stent would go into a Xience box, the second stent into a Boston Scientific Promus box,'' said Jeff Mirviss, vice president of marketing for Boston Scientific. "That is the only difference -- the color of the box.
"The day [Abbott] gets approved [by the FDA] is the same day we get approved,'' he said.
This unusual arrangement, the first in the medical-device industry, stems from Boston Scientific's $27 billion purchase of Guidant Corp. in 2006, which forced the sell-off of Guidant's highly coveted stent business because of antitrust concerns.
Abbott paid $4.1 billion for Guidant's vascular and endovascular business, diving into the ultra-competitive $2 billion drug-coated stent market. For a while, Boston Scientific will pay Abbott a 40 percent royalty on sales of Promus, according to the agreement.
Stents are tiny mesh tubes used to unclog arteries. When stents are coated with drugs, vessels are less likely to renarrow. Only two drug-coated stents are available now in the United States: Taxus, made in Maple Grove by Boston Scientific, and Cypher, a Johnson & Johnson product.
But a new generation of stents looms -- Xience and a stent by Medtronic Inc., called Endeavor -- hungry to take share from existing players. Count Promus in the mix, too.
The clinical data for Xience (and Promus) are excellent, according to Timothy Nelson, an analyst with FAF Advisors Inc., a division of U.S. Bank. Data released by the FDA this week indicated that Xience stents keep arteries open as well as Boston Scientific's Taxus, and patients were about half as likely to suffer heart attacks, require repeat procedures or die.
The real payoff for Boston Scientific is from a marketing perspective, Nelson said. "With Promus, Boston Scientific will have the broadest line of vascular products in the market.''
In addition, Boston Scientific is poised to market the next-generation version of Taxus, called Taxus Liberte, billed as the first stent specifically designed for a drug coating. (Early versions simply took a first-generation bare-metal stent and coated it with drugs.)
Mirviss said Taxus Liberte has better clinical results in patients "because the drug is delivered more evenly throughout the stent struts. The stent is also thinner and easier for doctors to use."
Taxus Liberte will hit the market once an FDA warning letter is lifted. The letter pointed out quality problems with manufacturing processes and prevented the company from marketing new products until the issues are resolved. Boston Scientific executives say the letter could be lifted by the second quarter of 2008.
Once Boston Scientific transfers Promus technology to a next-generation stent, it no longer will pay fees to Abbott. That means Promus then will be made at Boston Scientific's cardiovascular division in Maple Grove, which employs about 3,000 people, and in Ireland.
But Fridley-based Medtronic isn't sitting by quietly. The company is confident it can launch its Endeavor stent by the end of the year.
"If Xience eventually follows Endeavor into the U.S. market, it will do so with a safety profile that has been shown to be comparable to that of the vintage stents, clearly enabling Endeavor to stand apart," said Scott Ward, president of Medtronic's cardiovascular business.
Janet Moore • 612-673-7752