| US: Medtronic Endeavor stent had more complications than J&J rival
Found: Mon Mar 15 09:01:27 2010 PDT
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Medtronic Endeavor stent had more complications than J&J rival
Bloomberg News
Published: 3/15/2010 10:49 AM
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Medtronic Inc.'s drug-coated heart stent Endeavor had more deaths and complications than Johnson & Johnson's rival device to prop open clogged arteries, research funded by both companies found.
After 18 months, Medtronic's Endeavor stent was tied to heart attacks, deaths and repeat surgeries in 9.7 percent of patients, compared with 4.5 percent for J&J's Cypher, according to a study presented today at the American College of Cardiology meeting in Atlanta and published online by the journal Lancet.
Results confirm findings from similar nine-month data reported in 2008 that found Cypher safer, said Micheal Maeng, lead researcher of today's 2,332-patient study. The new findings may cut Medtronic's share of the $4 billion global market for drug-coated stents to 18 percent, from 20 percent, said Jan Wald, an analyst with Noble Financial Group in Boston.
"If you have to compare the two stents, the Cypher stent is a better stent," said Michael Maeng, the study's lead researcher and a cardiologist at Aarhus University Hospital in Denmark, in a statement. He has received payments from both Medtronic and J&J.
The design of the study "raises questions about the reproducibility, viability and applicability of the results," Medtronic said in a statement yesterday. The Minneapolis-based drugmaker faulted the study's reliance on data from a Danish patient registry rather than direct physician follow-up of patients, and the method by which investigators collected data on certain complication rates.
Jeffrey Leebaw, a spokesman for New Brunswick, New Jersey- based J&J had no immediate comment yesterday on Medtronic's statement. Maeng didn't return calls seeking comment.
Shares
Medtronic shares rose 3.8 percent, or $1.65, to $45.59 at 10:22 a.m. in New York Stock Exchange composite trading. J&J increased 13 cents to $64.31.
Stents are tiny wire-mesh tubes used to prop open arteries after surgeons have cleared them of fatty deposits that otherwise may obstruct the flow of blood. The current generation of devices is coated with chemical polymer and drugs to prevent tissue from growing inside the stent and reblocking the artery, a main complication of earlier bare-metal versions.
The trial, called Sort Out, found a 2.1 percent rate of heart attacks in those with the Endeavor, compared with 0.9 percent for Cypher. About 8 percent of Endeavor patients required a repeat artery-clearing procedure compared with 3.3 percent of the Cypher group.
Medtronic reported revenue of $603 million from Endeavor and other drug-coated stents in its fiscal year ended April 24, 2009. J&J reported $919 million of revenue from its drug-coated stent Cypher and similar devices last year. They compete with similar devices made by Abbott Laboratories and Boston Scientific Corp.
Limited Erosion
Wald said Medtronic's market share erosion would be limited because similar results were seen in earlier research. "Any big shift that is likely to happen will be with the next generation of stents," Wald said.
The market for drug-coated stents is dominated by Xience, a device made by Abbott, of Abbott Park, Illinois, and a version of that device called Promus sold by Boston Scientific, of Natick, Massachusetts, said Mike Weinstein, an analyst with JPMorgan Securities in New York.
"The market is shifting to the Abbott and Boston Scientific Xience and Promus stents," Weinstein said in a telephone interview yesterday.
Based on earlier studies of Endeavor that showed a more favorable safety profile, Maeng said he expected his study to show that Medtronic's device "would provide strong protection against general stent thrombosis and heart attack," Instead, there was a "high risk" of blood clots forming on the stent and heart attacks soon after surgery, Maeng said.
'Not New'
The Sort Out trial results "are not new to physicians or the investment community and the impact will be less than if this were a first-time report," said David Kandzari, a cardiologist at Scripps Clinic in La Jolla, California, who has led other studies on Endeavor and is a consultant to Medtronic.
The study was funded by Medtronic and J&J, of New Brunswick, New Jersey. Maeng said he has received speaking fees from J&J, consulting fees from Medtronic, and travel grants from both companies.
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