By Denise Roland
Deep brain stimulation, an established therapy that modifies the
brain's circuitry to treat symptoms of Parkinson's disease and
other movement disorders, is attracting fresh attention from
medical-device makers who believe it is underused.
St. Jude Medical Inc. recently introduced a new DBS system in
the U.S., and Boston Scientific Corp. is planning its own entry
late next year. Both already sell the implantable devices for DBS
in Europe.
The shake-up in the U.S. reflects the promise that St. Jude --
which recently combined with Abbott Laboratories -- and Boston
Scientific see in a market that for years has been served by just
one company: Medtronic PLC.
Although DBS accounts for just $500 million of Medtronic's
roughly $30 billion in annual revenue, it is one of the company's
fastest-growing areas, expanding around 9% a year, according to a
company presentation at a medical meeting in late 2015. The price
of a Medtronic DBS system ranges from about $18,000 to $35,000.
"The last two decades, Medtronic has done the yeoman's work of
creating and legitimizing DBS," said Brett Wall, head of the
company's brain business. "It's about time someone else got in this
market."
Parkinson's, an incurable, degenerative neurological disease,
affects around one million people in the U.S. DBS, which involves
embedding a wire in the brain and a pacemaker-like unit in the
chest, has been shown to significantly increase control over
symptoms in those with advanced Parkinson's.
But not all patients stand to benefit from DBS. Some can control
their symptoms using medication alone, while others have
complications, such as dementia, that rule out surgery.
Even so, all three medical-device companies believe only a
fraction of eligible patients are undergoing the surgical
procedure. Maulik Nanavaty, head of neuromodulation at Boston
Scientific, estimates that about 13% of Parkinson's patients who
could benefit from DBS have used it. Medtronic puts that figure at
around 25%.
One reason for the modest use in the U.S., according to Allen
Burton, medical director of neuromodulation at St. Jude, is a lack
of familiarity. Many Parkinson's patients are treated by
primary-care doctors or community neurologists who lack connections
with the roughly 100 specialist centers across the country that
offer DBS.
The cost of DBS implantation can reach $100,000, but insurers
typically reimburse most or all of the bill, according to the
National Parkinson Foundation. As much of a deterrent to use is the
time commitment required. The procedure involves a two-day hospital
stay, plus numerous consultations before and after treatment. There
is also the travel time to the specialist centers.
St. Jude is working with community neurologists to raise the
profile of DBS and is considering advertising the procedure
directly to patients. The device makers are also betting that
improving the precision of DBS will make it more marketable.
With traditional DBS implants, the current radiates out from the
end of the wire. Now Boston Scientific and St. Jude have developed
devices that can "steer" the electrical impulse in a particular
direction, with the aim of reducing side effects such as mood
changes or speech difficulties. Medtronic plans to launch its own
steerable device in the next two to three years, Mr. Wall said.
It also is working on a way to vary the strength of the
electrical signal depending on the brain's own activity, though
that technology is at least five years away from launch.
Another approach: advocating use of DBS at an earlier stage. DBS
is typically used in patients with advanced Parkinson's, but the
Food and Drug Administration earlier this year said Medtronic could
market one of its devices when the disease had been diagnosed for
as little as four years. That decision followed a large study by
Medtronic showing that earlier-stage patients did better on
medication plus DBS, compared with medication alone.
Even with such advances, medical-device makers could come up
against a more fundamental problem: fear of surgery, particularly
on the brain. "Many people would avoid brain surgery if they have
other options," said Jeff Bronstein, a neurologist at University of
California, Los Angeles. "The risks are relatively small, but if
you happen to be in the 1% to 2% that has a stroke, that's a big
deal."
Concern about surgery risks means DBS is viewed "almost as a
last resort, " according to Patrick Hickey, an assistant professor
of neurology at Duke University School of Medicine who has received
grant funding from Medtronic. But he said it was gradually
"becoming part of the treatment program" as doctors became more
familiar with it.
Some believe DBS has more potential still. Among them are
researchers at Vanderbilt University, who believe it could go
beyond controlling the symptoms of Parkinson's to delaying the
progression of the disease itself.
David Charles, a professor of neurology at Vanderbilt who has
done consulting work for Medtronic, said the research team was in
the process of raising funds to run a large clinical test of that
hypothesis, after a small study showed early-stage Parkinson's
patients on standard therapy were two to five times more likely to
worsen in two years than those using DBS.
"DBS plus medicine seems to be not just a little better, but
potentially is far superior to standard therapy," Dr. Charles said.
"That still needs to be proven."
Write to Denise Roland at Denise.Roland@wsj.com
(END) Dow Jones Newswires
January 08, 2017 07:14 ET (12:14 GMT)
Copyright (c) 2017 Dow Jones & Company, Inc.
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