Medtronic heart-failure device approved for U.S. sale
Terry Fiedler
Star Tribune
Published 08/29/01
Medtronic CEO Art Collins is calling the imminent U.S.
rollout of its InSync device for treating heart failure the
company's 'largest new product introduction ever,' with
estimated first-year sales of 'well north of $100 million.'
The Fridley-based company announced Tuesday that it had
received Food and Drug Administration approval to market
the InSync domestically. Collins said it should be on the market
by the end of next week. The InSync has been sold in Europe
for three years.
Analysts have said the market for devices that
treat heart-failure could reach $1 billion
within three years. Beyond that, Collins said,
'we look at it as a $2 billion market and we
expect to be the clear leader.'
For the foreseeable future, Medtronic will be
the only company in the U.S. market. A panel of outside
experts recommended in July that the FDA approve
Medtronic's InSync device for domestic sale. The panel
rejected plans for a similar device made by Medtronic's closest
rival, Guidant Corp., which has its cardiac rhythm
management group headquarters in Arden Hills.
Guidant will submit a revised proposal before Sept. 6.
U.S. Piper Jaffray analyst Thomas Gunderson noted that
Medtronic won FDA approval four to six weeks earlier than
most people had expected. He added that new U.S. sales would
be in addition to the $40 million annually the company sells
overseas and in trials.
Fred McCoy, president of Guidant's cardiac rhythm
management group, called Medtronic's FDA approval
'excellent news for the ... people struggling with congestive
heart failure. We look forward to joining that marketplace.' He
would not speculate on how soon that might happen.
'This is a very significant market and it's significant that
Medtronic is in the market first,' said A.G. Edwards analyst
Jan Wald. 'But the market is big enough that two or three
players will do well.'
Wald estimated that Little Canada-based St. Jude Medical
would have a heart-failure product on the U.S. market in
about a year and that Guidant would get approval for its
Contak CD, which includes a defibrillator, by next summer.
Heart failure, also called congestive heart failure, is a condition
in which a damaged or overworked heart can't pump enough
blood. Heart attacks, high-blood pressure and valve disease are
among the leading precursors to heart disease. Its symptoms
include fatigue, chest congestion and the buildup of fluid in the
abdomen, feet or legs.
Nearly 5 million Americans have the condition and each year
about 500,000 new cases are detected. Heart failure is the
leading cause of hospital admissions in the country and it's
estimated that heart failure contributes to or causes 250,000
deaths a year.
Medtronic projects that about 650,000 of the 5 million
Americans with the condition are candidates for its InSync
device, which uses electrical current to help the heart pump
more efficiently. The InSync costs about $8,500 and is
surgically implanted in much the same way as a pacemaker.
The half-dollar sized device is used in combination with drugs,
which previously were the only treatment.
Clinical trials showed that the device helped increase exercise
capacity and the quality of life for some of the sickest
heart-failure patients.
Wald said the market will 'take shape kind of slowly' because
doctors who treat the condition will have to refer patients to
another doctor for an implant. He added the surgery is
relatively lengthy. A defibrillator implant might take 35 to 40
minutes, while an InSync implant might take more than two
hours.
Still, Collins said, heart-failure patients who could use the
device are 'very sick and in a mode where their condition is
deteriorating. They will take a proactive approach to find out if
the therapy benefits them.'
-- Terry Fiedler is at tfiedler@startribune.com .
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