Medtronic's Endeavor Poised to Enter Struggling Stent Market

BUSINESS NEWS

In October, FDA's circulatory system devices panel unanimously recommended full agency approval of the Endeavor drug-eluting coronary stent, manufactured by Medtronic Inc. (Minneapolis). The panel's recommendation was predicated on two conditions: a five-year follow-up study including 5000 or more patients, and labeling to emphasize the benefit of dual antiplatelet drug therapy for at least one year following stent implantation.

The Endeavor stent system comprises four components: a cobalt-alloy-based stent, the polymer phosphorylcholine, the drug Zotarolimus, and the stent delivery system. FDA's nine-member panel reviewed extensive data comparing Endeavor to Medtronic's bare-metal Driver stent and the only drug-eluting coronary stents currently available in the United States: Cypher, manufactured by Cordis Corp. (Miami Lakes, FL), a Johnson & Johnson company, and Taxus, manufactured by Boston Scientific Corp. (Natick, MA).

Scott Ward, president of Medtronic's cardiovascular business unit, expressed the company's pleasure with the panel's recommendation. "We are very pleased with the outcome of the panel meeting and appreciate the advisory committee's careful consideration of the extensive data on the Endeavor stent," he said. "We will continue to work with FDA to bring the Endeavor stent to the U.S. market as soon as possible so that patients and physicians in the U.S. can benefit from this next-generation technology."

When Endeavor finally receives FDA approval, it will face a much more daunting market than did its predecessors. Less than a year after Cypher and Taxus were both available in the United States, drug-eluting stents nearly displaced their bare-metal predecessors, capturing 85–90% of the market for coronary stents. As the devices continued to gain the support of interventional cardiologists, the market grew at a torrid pace, reaching a worldwide valuation of around $6 billion by the end of 2005.

In March 2006, however, the widely reported Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) study, presented at the annual meeting of the American College of Cardiology, suggested that angioplasty with stent implantation yielded essentially the same outcomes as drug therapy accompanied by lifestyle changes (e.g., diet and exercise).

Later that year, the market took a more serious blow, as a number of clinical studies raised concerns about potentially deadly blood clots associated with the use of drug-eluting stents. The resulting attention in the industry, business, and general-interest press resulted in a cooling of the market.

Dropping from their previous lofty utilization rates of 85–90%, drug-eluting stents presently account for around 65% of stent implantations in the United States. Overseas markets have declined as well, with the United Kingdom's National Health Service, the world's largest publicly run healthcare agency, considering whether or not to ban their use entirely and go back to bare-metal devices.

More long-term clinical data about the use of drug-eluting stents are expected to dispel many of the safety concerns that have arisen over the past two years. Even so, most analysts anticipate a slow recovery for the market, particularly as next-generation devices are introduced.

Copyright ©2007 MX