Medtronic gets OK to sell heart device in Europe

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.