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Medtronic gets OK to sell heart device in Europe

Posted on: Sunday, 31 July 2005, 16:00 CDT

By Debra Sherman

CHICAGO (Reuters) - Medical device maker Medtronic Inc. on Sunday said it received approval from European health regulators to sell a heart device that keeps arteries open.

Medtronic said it will immediately roll out in Europe, the Middle East and Asia -- more than 40 countries in all -- its Endeavor drug-eluting stent, a tiny, wire mesh tube coated with medicine that props open arteries during angioplasty procedures.

The medicine, which is licensed from Abbott Laboratories Inc., keeps the treated coronary arteries from reclogging, a common complication when traditional bare metal stents are used.

The worldwide market for drug-eluting stents is $5.5 billion and growing rapidly. Johnson & Johnson and Boston Scientific Corp. dominate the worldwide market for these devices, which have driven profits at both companies during the past year.

In a telephone interview with Reuters, Scott Ward, president of Medtronic's vascular business, said he believes the company will exceed the 15 percent market share within 12 months that Wall Street analysts were anticipating. He estimated the size of the market outside the United States, excluding Japan, to be between $1 billion and $1.5 billion.

Ward forecast Endeavor sales to be $30 million to $50 million per quarter for the next four quarters.

"It takes time to get the market share ... but we've got 80,000 units and we're ready for a blockbuster launch," Ward said, adding that most Wall Street analysts did not seem to expect the company to win European approval until November or December.

"I think this will come as a positive surprise for most of them," he said.

Ward said Endeavor is easier for doctors to use than those currently on the market and has a good safety profile, which is why he expects many doctors to switch from J&J's Cypher stent or Boston Scientific's Taxus stent.

Minneapolis-based Medtronic is still conducting clinical trials in the United States and does not expect to have the device on the U.S. market, estimated at about $3.5 billion, until 2007. Ward said its U.S. trial is on track.

Medtronic will report results of a recently completed trial, dubbed Endeavor III, at the Transcatheter Cardiovascular Therapeutics meeting in October.

Ward said he expects enrollment for a key fourth trial, Endeavor IV, to be completed by April 2006 and expects to submit the data to the U.S. Food and Drug Administration for approval by mid-2006.

Source: REUTERS

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