Medtronic Targets 2007 for U.S. Market Entry of Endeavor Stent

While much of the attention at the recently held meeting of the American College of Cardiology (ACC; Bethesda, MD) was on the head-to-head matchup between the Cypher and Taxus drug-eluting coronary stents from Cordis Corp. (Miami Lakes, FL) and Boston Scientific Corp. (Natick, MA), respectively, the Endeavor stent from Medtronic Inc. (Minneapolis) gained new respect from medtech industry analysts as a potential market contender.

Medtronic reported on the results of its Endeavor II trial at the ACC meeting in Orlando, FL. In a company-sponsored study of 1197 patients at 72 facilities in 17 countries, Endeavor successfully met all of its endpoints in a comparison study with its bare-metal stent counterpart, Driver.

The primary endpoint of the trial was target vessel failure (TVF) at nine months. TVF is a composite figure, which includes death (from any cause), myocardial infarction (heart attack), and vessel retreatment (revascularization). Of the patients who received an Endeavor stent, 95% required no further treatment during the nine-month assessment period. The TVF rate with Endeavor was 8.1% in comparison to 15.4% in the bare-metal stent control group.

Other important endpoint results of the Endeavor II trial:

• The Endeavor group demonstrated a significantly lower rate of revascularization: 4.6% versus 12.1% for the bare-metal stent group. Cardiovascular surgeons typically cite revascularization as a critical marker of the effectiveness of drug-eluting stents.
• In another positive indicator, patients with Endeavor had a 9.5% incidence of restenosis or reclogging of the stented vessel, versus 32.7% for the bare-metal stent control group.
• The measured “late loss” or the amount of vessel diameter that has been reduced or “lost” as a result of restenosis within the stent site was 0.62 mm with Endeavor compared with 1.03 mm in the control group.

Commenting on the results of the clinical trial, Richard M. Kuntz, MD, an associate professor at Harvard Medical School and chief of the division of clinical biometrics at Brigham and Women’s Hospital (Boston), who was one of the principal investigators on the study, said, “These are extremely solid clinical and angiographic results, supported by a comprehensive base of data compiled through the outstanding work of the Endeavor II investigators around the world. The study had an impressive 88% follow-up rate in the assigned angiographic cohort and a 97% follow-up rate in the clinical cohort. The result is a strong body of data that provides a clear and compelling case for the outstanding performance of the Endeavor stent.”

Leon: Safety first.

Citing the incidence of “zero thrombosis (clotting at the stent site) beyond thirty days,” Martin B. Leon, MD, a principal investigator of the Endeavor III and Endeavor IV clinical trials and chairman of the Cardiovascular Research Foundation (New York City), said, “The Endeavor stent has demonstrated an impressive safety record that should not be overlooked. It’s among the safest drug-eluting stent systems studied to date.”

In a postpresentation interview, Scott Ward, president of Medtronic’s vascular business, said that he believed “people will be very surprised. Analysts have underestimated this program for a really long time.”

Medtronic, the world’s largest cardiac device maker, and the market leader in the cardiac rhythm management sector, was an early leader in coronary-stent development, but has experienced difficulties in combining drug-eluting technology with its highly regarded cobalt alloy bare-metal coronary stent platform.

Ward: Surprise!

Commenting on Medtronic’s next moves with Endeavor, Ward said, “With this compelling and definitive data, we look forward to working on our efforts to commercialize the Endeavor stent outside the United States this spring. We will present the final results from the Endeavor III trial in October and we intend to begin the Endeavor IV trial in the next few weeks.”

Following the ACC presentation, the talk among industry analysts was no longer about whether Endeavor would ever be a factor in the U.S. market, but how much share it can eventually capture from the competition. Medtronic is aiming for a target date of early 2007 for U.S. market introduction of Endeavor.

Medtronic, with just under 31,000 employees, reported annual sales of $9.09 billion for the year ending April 30, 2004, an 18.5% increase over 2003 revenues of $7.67 billion.

© 2005 Canon Communications LLC

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