WSJ: Medtronic Says Stent Trial Meets Secondary Goals

CHICAGO — Medtronic Inc. (MDT) said its Endeavor III drug-eluting stent trial barely missed its main goal in a patient trial, and that secondary goals were met.
On the whole, the company said, data from the trial put Medtronic’s Endeavor stent in the same safety and efficacy category with competitors Johnson & Johnson and Boston Scientific Corp., and will allow Medtronic to file next year for U.S. approval of its product, with final Food and Drug Administration approval coming sometime in 2007.
Stents are tiny metal tubes designed to keep arteries propped open after angioplasty. Drugs added to the stents can help prevent renarrowing of the vessels.
The main goal of the 436-patient trial was to compare Endeavor with J&J’s Cypher stent in the category of in-segment late loss. This refers to the difference in the width of a vessel just after stenting versus several months later. A small narrowing is almost always the case, and is considered relatively benign. But more advanced narrowing can eventually lead to blockage that must be retreated. “We narrowly missed,” said Scott Ward, president of Medtronic Vascular, referring to narrowing of the vessel width.
Patients in the trial received either a Cypher or an Endeavor stent, with 323 of the 436 receiving Endeavor. The goal was to prove Medtronic’s stent to be non-inferior to Cypher.
In other categories, however, Medtronic said its stent was clinically equivalent to J&J’s. For instance, in measuring the need for physicians to go back in and retreat the same lesion weeks or months after the original procedure due to complications, Medtronic’s stent had a 6.3% rate after nine months, compared with 3.5% for Cypher.
In the category of major adverse coronary events, which can include everything from need for repeat procedures to heart attack to death, Endeavor’s rate was 7.6%, compared with 7.1% for Cypher. The rate of target vessel failure was 12% for Endeavor and 11.5% for Cypher.
Cordis, J&J’s coronary company, issued a statement that said, “As with other drug-eluting stents, the real test will be how the Endeavor stent performs over time and whether it can perform well in complex lesions.” Boston Scientific didn’t have an immediate comment.

Posted by on October 17th, 2005 at 10:51 pm


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