UPDATE: St. Jude Keeps Growth Outlook, Reviews Valve Plans
February 06 2009 - 12:35PM
Dow Jones News
St. Jude Medical Inc. (STJ) on Friday backed its long-term
earnings growth outlook while detailing for the first time its
interest in the market for replacement heart valves that don't
require major surgery.
The so-called transcatheter valves, which can be threaded into
place through arteries, are a key new product and growth driver for
Edwards Lifesciences Corp. (EW). The valves also have attracted the
attention of medical-device heavyweights Medtronic Inc. (MDT) and
Johnson & Johnson (JNJ).
Those companies have said that they are pursuing the market. St.
Jude, which already competes with Edwards in the market for valves
that require more significant surgery, is also entering the
fray.
"We've been busy this year" expanding investment in that area,
said Daniel J. Starks, St. Jude's chairman and chief executive,
speaking at the company's annual investor conference.
He also reiterated the St. Paul, Minn., company's goal for
expanding per-share earnings at a minimum 15% compound annual
growth rate. The company, where implanted pacemaker and
defibrillator heart devices are the biggest business, also targets
double-digit sales growth.
St. Jude's shares were recently trading 4 cents lower at
$37.16.
St. Jude has completed initial animal work studying
transcatheter valves and plans its first clinical implants to study
the devices in humans late next year, using one type of delivery
approach. First implants with another type of delivery approach are
anticipated in late 2011, and market introduction is several years
away.
European approval for one delivery approach could come in mid
2012, and approval for the other approach could come in 2013, said
Frank J. Callaghan, president of St. Jude's cardiovascular
division. He the company isn't ready yet to give guidance regarding
potential U.S. approval - accessing the U.S. often comes after
Europe due to requirements for bigger studies.
Despite the long wait, transcatheter valves are generating some
enthusiasm in a medical-devices sector where major markets are
showing their age and there is high interest in new growth drivers.
Edwards is one of few device makers that actually saw its stock
price rise last year amid brutal broader market conditions as early
sales of its transcatheter valve exceeded expectations.
Edwards' "Sapien" valve, available in Europe so far, garnered
sales of $53 million last year, and the company has projected sales
of $75 million to $95 million in 2009. A private company called
CoreValve is already competing with Edwards in Europe, but Edwards
believes it has a long head start in its push toward the U.S.
market. Its major U.S. study is rolling along.
Sapien is a replacement for faulty aortic valves, or the valves
that send blood to the body from the heart's main pumping chamber.
The valves are viewed as an option for sick patients who may be too
frail to withstand the rigors of major heart surgery.
There are two ways to deliver the devices to the heart,
depending on a patient's condition. One, called a transfemoral
procedure, involves passing the valve up a blood vessel through a
small incision in the leg. There is another option called a
transapical procedure, in which the valve is delivered between the
ribs, for patients whose blood vessels may not accommodate the
first delivery method.
St. Jude is also focused on aortic valves that can be put in
place with both delivery methods. Callaghan said St. Jude has
settled on a self-expanding metal framework design for the valves,
which are surrounded by this framework and then expanded once
they've been delivered.
Callaghan said that testing to determine the device's durability
is well underway and that St. Jude is very pleased with the
results.
"This is certainly a segment we are very excited about and
pursuing very rapidly," he said.
-By Jon Kamp, Dow Jones Newswires; 617-654-6728;
jon.kamp@dowjones.com
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