One other article from the St Paul Pioneer press. Quite a nice overview on what the market is doing for congestive heart failure. This is a future and will not be released for over a year. It could take longer. But interesting to see what all the companies are working on.
Good luck,
Mike
A Race for Life
The push is on to develop medical technology
Medical device makers are pushing through technology designed to
Some 5 million Americans suffer from chronic heart failure, and
thousands more are diagnosed with the often-fatal condition each year.
The push is on to develop medical technology to treat what threatens to
become an epidemic.
The first Medtronic product expected to be approved by U.S.
regulators for treatment of chronic heart failure is the pacemaker-like
InSync.
Guidant is on track to get U.S. approval first for its Contak CD, which
incorporates both a pacemaker and defibrillator.
KAREN PADLEY STAFF WRITER
For years, Twin Cities medical device makers have concentrated on
pacemakers and defibrillators, which, respectively, treat heart beats that
are too slow and too fast.
Now, they are taking on a problem that affects even more people --
chronic heart failure.
Medtronic, Guidant and St. Jude Medical Inc. are working on ways to
help the 5 million Americans with the often-fatal condition by extending
their existing technologies.
It's a neck-and-neck race, with an uncertain outcome. Much will
depend on clinical trials now under way, which should show which
patients would benefit most from the devices.
Analysts say the potential demand probably will be bigger than the $1.4
billion spent on defibrillators and perhaps the $2.6 billion spent on
pacemakers last year.
``Heart failure's a $1 billion market now, and it's growing 20 percent to
30 percent a year,' estimated Jan David Wald, an analyst with George
K. Baum & Co.
Heart failure occurs when the heart's pumping ability is impaired, often
as a result of high blood pressure, obesity, diabetes, a heart attack or
coronary artery disease. Symptoms include shortness of breath, fatigue,
swelled ankles and angina.
The older you are, the more likely you are to have it. About 10 percent
of those older than age 70 have been diagnosed with heart failure
compared with 5 percent of those ages 60 to 69.
Pair that with the aging of the baby boom generation and the result is
often called an epidemic by health care officials. A total of 700,000
new cases were diagnosed in 1994, up from 400,000 in 1988. Half of
those with heart failure die within five years.
``It's the only cardiac disease that is increasing in prevalence today,'
said Dr. Jay Cohn, a University of Minnesota professor and founding
president of the Heart Failure Society of America. ``The others have all
yielded to recognition and early treatment.'
As a result, the demand for new treatments is increasing. Drugs,
including blood pressure drugs such as ACE inhibitors and
beta-blockers, are now most commonly used to treat heart failure. Side
effects can sometimes be a problem, though, and patients may not
always take their medicine the way they are supposed to.
The drugs also don't have much impact on heart rhythm problems that
can develop. In a normal heart, both of the heart's lower chambers, or
ventricles, are supposed to contract at the same time. In patients who
suffer heart failure, however, the right ventricle will beat first followed
by the left ventricle. The resulting ``hula'-like motion is very inefficient.
Enter Medtronic, Guidant and St. Jude Medical. All are testing
pacemaker-like devices they hope can resynchronize the heart's lower
chambers and improve the quality of life for heart failure patients.
Medtronic, with fiscal 1999 revenues of $4.1 billion, is No. 1 in both
pacemakers and defibrillators. It's followed by Indianapolis-based
Guidant, which had 1998 revenues of $1.9 billion, and St. Jude
Medical, with 1998 revenues of $1.0 billion.
Medtronic and Guidant already have devices on sale in Europe. St.
Jude hopes to join them in the first quarter of this year. All have U.S.
clinical trials under way and could reach the market as early as 2001.
To treat heart failure, the companies have developed three new types of
products. There's the device itself, which senses when
resynchronization is needed. There's also a lead or wire that delivers an
electrical jolt to the surface of the heart's left ventricle. It must be
threaded through the heart's right side and into a coronary vein that
leads, often tortuously, to the surface of the heart's left side. Various
tools also had to be developed that allow doctors to quickly and
accurately place the lead in the coronary vein.
The similarities end there, however. The first Medtronic product
expected to be approved by U.S. regulators is the pacemaker-like
InSync. The Fridley-based company plans to add a defibrillator with its
InSync ICD and is developing an implantable heart monitor for heart
failure patients called the Chronicle.
Guidant is on track to get U.S. approval first for its Contak CD, which
incorporates both a pacemaker and defibrillator. The company, which
owns Arden Hills-based Cardiac Pacemakers, notes that heart failure
patients have a much greater risk of dying from sudden cardiac death,
which can be treated with a defibrillator, than the general population.
The company also sells the pacemaker-like Contak TR in Europe.
For its part, St. Jude Medical is working on the Frontier, which would
treat both heart failure and atrial fibrillation. In atrial fibrillation, the
heart's upper chamber quivers instead of pumping, increasing the
likelihood of stroke-causing blood clots. About 25 percent of all heart
failure patients also have atrial fibrillation.
St. Jude also is exploring a system that stimulates only the left side of
the heart.
Analysts said Medtronic and Guidant appear to be neck and neck in
Europe. However, they cautioned that it's probably too soon to tell
who the eventual winner will be. The market also is so big that there
may be room for all three, analysts said.
``It doesn't matter who's first to market,' said Tim Nelson, an analyst
with John G. Kinnard & Co. ``The question is market development and
who will be able to reach the heart doctors with a portfolio of
products.'
Analysts expect the devices to have healthy margins because of the
technological advances that were necessary. They estimate those with
only a pacemaker may run roughly $5,000 to $10,000 apiece, while
those with a pacemaker and defibrillator could be about $15,000 to
$20,000.
The market is expected to build slowly, however, because heart failure
patients are often seen by general practitioners and internists who don't
always take advantage of the latest technology. While initial trial results
show patients' quality of life improves noticeably, the companies are
planning large clinical trials involving thousands of patients to measure
patient mortality and to boost market acceptance.
``You need market development trials for these things to really grab
hold of the market and go,' said Sanjiv Arora, a Dain Rauscher
Wessels analyst.
He added that heart failure devices probably will be adopted faster than
defibrillators, which required an entire decade, because the devices will
be used with drugs instead of replacing them.
Heart failure specialists are hoping to raise awareness of the problem
among doctors and the public alike in the coming months. They say
some heart failure patients may incorrectly consider their diagnosis a
``death knell' and fail to seek treatment as a result.
``The underlying disease can be treated effectively and these people
can live a normal life,' said Cohn, of the University of Minnesota,
adding that early diagnosis and treatment is important.
He noted the Heart Failure Society of America, which is based in
Minneapolis, plans a major national public relations campaign next
month during Valentine's Day week. Those involved are expected to
include TV celebrities Willard Scott and Larry King.
Cohn said the growing incidence of heart failure is an expensive burden
for the nation's health care system. It's a leading cause of hospitalization
among Medicare recipients.
``We spent about $38 billion a year to take care of heart failure
patients, or about 15 percent of the total healthcare budget,' he said.
``It's costing society a tremendous burden.'
As a result, analysts predict heart failure will provide plenty of
opportunities for medical device makers as the 21st century begins.
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