Abstract
Introduction
A few years after their introduction in 2002, drug-eluting stents had all but
replaced bare-metal stents in the treatment of coronary heart disease,
capturing up to 90% of the market. Physicians favored the new stents primarily
because of their ability to minimize the risk of restenosis associated with
bare-metal stents. Recently, however, new safety concerns have begun to erode
the market share of drug-eluting stents. The promise of next-generation
drug-eluting stents that are beginning to emerge-including Medtronic' s
Endeavor, expected to launch in the United States in late 2007, and Abbott' s
Xience, currently in clinical trials in the United States and Japan-is likely
to help the drug-eluting stent market rebound from its current low. However,
lingering safety concerns and the possibility of competitive pricing may keep
the market from achieving its earlier high.
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- The need to effectively compete with the next generation of drug-eluting
stents has prompted the current market leaders-Johnson & Johnson and Boston
Scientifi c-to acquire companies with next-generation stents in their
pipelines. How do next-generation stents differ from currently available
drug-eluting stents? Will the recent mergers of Boston Scientifi c and Guidant
and Johnson & Johnson and Conor Medsystems help the market leaders to retain
their market dominance?
- Recent concerns that drug-eluting stents are associated with increased
risk of late stent thrombosis arise from data on just two products-Boston
Scientifi c' s Taxus stent and Cordis/Johnson & Johnson' s Cypher stent. What
competitive opportunities does the potential for late stent thrombosis offer
to manufacturers of other drug-eluting stents? How do current concerns about
the risk of late stent thrombosis affect the outlook for Medtronic' s Endeavor
stent, if it receives approval in the United States?
- To acquire Guidant, Boston Scientifi c not only took on a heavy debt load,
it also struck a deal with Abbott Laboratories that gave Abbott rights to
Guidant' s Xience V DES platform. Was the decision to acquire Guidant a good
strategic move for Boston Scientifi c? Will Boston Scientifi c' s privatelabel
Xience stent, Promus, affect the company' s overall sales of drug-eluting
stents?
- Recent safety concerns about drug-eluting stents have dampened the early
enthusiasm for this technology. How is the FDA likely to respond to the
recent safety concerns about drug-eluting stents? Is the drug-eluting stent
market likely to rebound from its recent fall?
- In March 2007, Medtronic released two-year results from the largest and
longest drug-eluting stent clinical trial program to date. What advantages
does Medtronic' s Endeavor stent offer over existing drug-eluting stents? How
is the availability of the Endeavor stent likely to affect the market share of
the Taxus and Cypher stents?
Scope
- Use of stents in coronary heart disease: the limitations of
“balloon” angioplasty; introduction of bare-metal stents; the
advantages and mechanisms of drug-eluting stents.
- Market leaders: Boston Scientifi c' s Taxus versus Cordis/Johnson &
Johnson' s Cypher; the takeover battle for Guidant.
- Recent concerns: the risk of late stent thrombosis; discontinuation
of antiplatelet therapies; the effects of drug-eluting stents on coronary
collateral functions; FDA conclusions.
- Emerging innovations: new stents from Medtronic, Abbott/Boston
Scientifi c, Conor Medsystems, and Biosensors.
- Outlook: upcoming diffi culties with regulatory approval; potential
growth of antiplatelet medications; the emergence of competitive pricing;
future competition from bioabsorbable stents.
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