MEDLINEplus New Heart Failure Treatments Promise Hope.htm

February 6, 2002

MEDLINEplus: New Heart Failure Treatments Promise Hope-

http://www.nlm.nih.gov/medlineplus/news/fullstory_5654.html -

New Heart Failure Treatments Promise Hope

Reuters

Saturday, January 12, 2002

By Julie Steenhuysen

CHICAGO, Jan 11 (Reuters) - A new class of pacemakers will likely debut this

year, offering new hope for the 5 million Americans suffering congestive heart

failure--a disease that is the most common cause of elderly hospitalization.

Major medical device makers, including Medtronic Inc. and Guidant Corp., are

seeking US regulatory approval for a slate of devices to treat heart failure--a

market that could reach $16 billion.

If approved, doctors will see advances in bi-ventricular pacemakers, a new kind

of therapy that electrically stimulates the heart to beat more efficiently.

These pacemakers may also be equipped with implantable defibrillators that can

revive a patient whose heart had stopped functioning.

" It's a touchstone year, " said Banc of America Securities analyst Kurt Kruger,

referring to the slate of heart failure treatments set for approval in 2002. " In

the past, doctors put patients on drugs and basically sent them home to die. "

The new treatments offer hope for people who suffer congestive heart failure, an

often-fatal condition that slowly starves the body's organs of oxygen. The

condition is the most frequent reason for hospitalization in the United States

for people over 65, and kills almost 285,000 yearly.

The new stopwatch-sized pacemakers have wires leading to the heart's ventricles

and are implanted in the chest to deliver a mild shock to help bring a patient's

heartbeat back into normal rhythm.

Until recently, treatment options for the disease were limited to drug therapy.

Although drugs were effective in treating symptoms, they were incapable of

addressing damage to heart tissue that reduces its pumping function.

NEW RHYTHM

Despite its name, congestive heart failure is a not a sudden, life-ending event.

It typically results after age, illness or a heart attack has left a patient's

heart muscle so damaged it can no longer circulate enough blood. It can result

in fatigue, shortness of breath and swelling of feet.

For almost half of patients with advanced heart failure, electrical impulses no

longer occur in a coordinated rhythm, further reducing the heart's

effectiveness.

For those patients, bi-ventricular pacemakers can provide relief, said Douglas

Zipes, chairman of cardiology at Indiana University and president of the

American College of Cardiology.

" What we're doing with our pacing is changing the sequence of the electrical

events, " he said. The process, known as cardiac resynchronization, increases the

efficiency of the heart's pumping function.

Minneapolis-based Medtronic, the world's largest medical device maker, sells the

only resynchronization device on the US market. Approved last August, the device

has seen rapid acceptance, with sales forecast to exceed $100 million by the end

of Medtronic's fiscal year in April, said Ursula Gebhardt, general manager of

Medtronic's heart failure unit.

In 2002, Medtronic expects to expand its product line with the addition of the

InSync ICD, a device equipped with an implantable cardiac defibrillator. The

InSync ICD is intended to guard against sudden cardiac death by delivering a

massive shock to restart a patient's heart. The condition accounts for nearly

half of the deaths from people with heart failure. An US Food and Drug

Administration (FDA) panel will evaluate the device in early March.

Medtronic also is seeking approval this year for a new delivery system and

leads, the wires that carry the electrical signal to the heart's ventricles.

" The implant technique is getting simpler, " Gebhardt said.

This fall, Medtronic expects FDA approval of the InSync III, a device equipped

with software that allows physicians to adjust treatment based on a patient's

recovery.

" Rather than being in a hospital and putting them on a monitor, we'll have the

capability of making these implanted devices function like a coronary care

unit, " Zipes said.

GUIDANT'S DEVICES

Medtronic will face competition from Indianapolis-based Guidant in 2002. The

cardiovascular device maker expects the FDA to rule in March on its Contak CD, a

device that failed to gain approval from an FDA panel in July.

Since then, Guidant has been working closely with the agency to demonstrate the

device's effectiveness.

Guidant has a lot riding on approval of Contak CD. Chief Executive Ronald

Dollens told Reuters that devices to treat heart failure represent a $16 billion

market opportunity.

" We think we have identified a way for (the FDA) to see additional input that

would give them great confidence on the efficacy of the device, " he said in an

interview.

Guidant also expects to benefit from the positive results of its MADIT II study

of defibrillator use in heart attack patients. Fred McCoy, president of

Guidant's Cardiac Rhythm Management unit, said results of the study could double

the number of people who would qualify for an implantable defibrillator to

600,000 patients a year.

Since 75% of the patients participating in the MADIT II trial had heart failure,

McCoy said the results show the need for a defibrillator back-up in cardiac

resynchronization.

Like Medtronic, Guidant also plans to add diagnostic features to its

resynchronization devices in 2002. Dollens said the company is working on its

third-generation device, which he said could be on the US market by the fourth

quarter.

" Already Medtronic has two quarters under his belt and this has been a smashing

success so far, " Kruger said.

He said this year will determine whether that success was based on clinical

curiosity, or real demand: " This could be proof positive that there is a

substantive market developing. "

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