Positive Studies Boost Stent Maufacturers as Market Competition Heats Up

BUSINESS NEWS

Following nearly two years of negative reports and speculation regarding the safety of drug-eluting stents, manufacturers of the devices had to be pleased with the almost universally positive clinical findings presented at the recently held joint meeting of the American College of Cardiology (ACC; Washington, DC) and the Society for Cardiovascular Angiography and Interventions (SCAI; Washington, DC) in Chicago. The most significant outcome of the meeting was the general consensus among researchers and industry analysts that drug-eluting stents, while continuing to demonstrate superior performance in preventing restenosis, do not present a greater risk of late-term thrombosis than their bare-metal counterparts.

Over the past two and a half years, widespread concern that drug-eluting stents might be linked to blood clots and potentially fatal cardiac events has resulted in a precipitous decline in their usage. The use of drug-eluting stents peaked at the end of 2005, when it represented 85–90% of all implanted coronary stents. By the end of last year, the utilization rate of drug-eluting stents is estimated to have dropped to 65%. During the same period, the U.S. market for drug-eluting stents declined dramatically from nearly $4 billion in annual sales to a current estimated valuation of around $2 billion.

Analysts agree that market recovery for drug-eluting stents is under way. But the eventual size of the drug-eluting stent market remains in question.

Venkat Rajan, a medtech analyst with Frost & Sullivan (San Antonio), doubts that drug-eluting stents will ever get back to the near-90% penetration rate they enjoyed in 2005. Nevertheless, Rajan still sees significant recovery ahead. "They could get back to the low 80% range, considering both the largely successful resolution of the safety issue and the introduction of more-advanced, next-generation devices," he says.

As recovery proceeds, stent manufacturers will face a market that is much different and more competitive than it was at the start of the downturn. The drug-eluting stent duopoly enjoyed by Cordis Corp. (Miami Lakes, FL), a Johnson & Johnson company, and Boston Scientific Corp. (Natick, MA) no longer exists. Medtronic Inc. (Minneapolis) received FDA approval for its Endeavor stent last February, and Abbott (Abbott Park, IL) expects to enter the market with its Xience drug-eluting stent before the end of the second quarter.

Thomas Gunderson, managing director and senior medtech analyst with Piper Jaffray & Co. (Minneapolis), says that "Endeavor should meet or beat expectations due to a history of extensive clinical trials and ease of tracking in the artery. However, the stent still does not offer a true rapid-exchange implanting system, which could stunt sales."