ST. LOUIS PARK, Minn. (AP) -- Don Falk stretched his right arm over his
head, past the faint marks where a surgeon sank two wires deep in his brain,
to show how uncontrollable tremors in his hand used to slap him awake in the
morning.

It was just one of many difficulties he suffered as his Parkinson's disease
advanced. Falk had trouble shaving and walking, and his medications caused
his head to twitch awkwardly, making him self-conscious in church.

"It's the day-to-day living that is so hard with Parkinson's," he said.

In May, Falk, 52, started to get better with the help of an emerging class
of implantable medical devices called neuromodulators - tiny machines that
stimulate the central nervous system to treat a host of disorders. Analysts
say they could be the next big thing for some of the market's hottest
medical technology companies.

Of course, the same hurdles that have stood in the way of other medical
technologies will have to be overcome, including getting government
approvals, securing adequate insurance reimbursements and persuading busy
doctors to learn to use the devices.

The deep brain stimulator silently pulsing away deep in Falk's head is made
by Fridley-based Medtronic Inc., a multibillion dollar medical device
company and the leader in the more than $1 billion market for
neuromodulators.

Medtronic has the only deep brain stimulator on the market, but St.
Paul-based St. Jude Medical Inc. is in clinical trials of its own version
through its newly acquired subsidiary Advanced Neuromodulation Systems Inc.
of Plano, Texas, which already sells spinal implants to treat chronic pain.

"I can tell you eight years ago, neuromodulation was not on the tip of
anybody's tongue, but today it is reaching critical mass and it's gaining
momentum and people are starting to imagine what is possible," said Chris
Chavez, president of St. Jude Medical's ANS division.

Cyberonics Inc. of Houston is the smallest player, with a device to treat
epilepsy by shocking a nerve in the neck, and Boston Scientific bought into
the market in 2004 by acquiring Sylmar, Calif.-based Advanced Bionics Corp.,
a maker of robotic inner ears.

The acquisitions show even some of the nation's hottest medical technology
companies see neuromodulation as part of their future, said Jan Wald, an
analyst for A.G. Edwards.

"They were looking for growth and they found it in neuromodulation," Wald
said.

Medtronic, St. Jude Medical and Boston Scientific don't break out sales
figures for their neuromodulation devices.

But ANS quarterly revenue rose 26 percent to $39.3 million during its last
quarter before St. Jude bought it in November for $1.4 billion. And
Cyberonics Inc. reported sales grew 19 percent to $31.3 million for the
quarter ended Jan. 27, though the company reported an overall loss on heavy
spending to prepare marketing of a newly approved neuromodulation therapy
for drug-resistant chronic depression.

Neuromodulators are technological cousins of implantable heart
defibrillators, a $5.5 billion market that's growing at nearly 20 percent a
year.

The devices do have some hurdles. While they've been shown to be safe and
effective at treating some disorders, they're generally recommended only
after drugs and other less invasive treatments fail.

The surgical procedure can be complex, and the devices themselves are
expensive, about $50,000 for the deep brain stimulator, less for other
devices in the class. And that doesn't include the costs of surgery.

The results are impressive, but "it's not a big moneymaker," said Dr.
Richard Veyna, Falk's neurosurgeon at Methodist Hospital in this Minneapolis
suburb. Not enough doctors know about the technology, and at current
insurance reimbursement rates simpler procedures are more profitable, Veyna
said.

Perhaps surprisingly, the risks of brain surgery rarely dissuade patients,
maybe because they are tired of living with Parkinson's symptoms and have
seen other treatments fail, he said.

Falk said he didn't hesitate about brain surgery. "My tremor was so bad I
just wanted it done," he said. His adult children didn't think twice either:
"They did not like me just sitting there, shaking and stuff."

Falk touts his procedure to other Parkinson's patients, telling them that
his medication has been cut by two-thirds and his insurance covered the
procedure.

Competition, higher volume and technological advances drove down the costs
of implantable cardiac devices, and could do the same for the
neuromodulators. Only a small number of people who might benefit from the
devices -- people who suffer from Parkinson's, tremors, epilepsy, chronic
depression or chronic pain -- are now getting them, Wald said.

"Neurostimulation to me, in fact the whole neurological space, is what
cardiology was 10 years ago," Wald said. "The opportunity is just vast."

Nearly all neuromodulation systems have the same general parts: Pulse
generators, wires that touch nerves and implanted batteries, which must be
replaced every few years. The most common versions are implanted in the
spine, not the brain.

Dr. Todd Sitzman, an anesthesiologist in Hattiesburg, Miss., has used them
in hundreds of patients with chronic pain over the last decade.

"Does it work from the patient's perspective? Without question," said
Sitzman, who sits on the National Pain Foundation's board of directors. "It
is a therapy that gives them some relief and some semblance of a life."

Companies are already pushing to develop new applications for the devices.
They see potential uses in treating diseases including depression,
obsessive-compulsive disorder, erectile dysfunction, traumatic brain
injuries, obesity, angina, incontinence and ringing in the ears.

St. Jude's Chavez said those possibilities, along with the aging populations
in the United States, Japan and Europe, made it likely that any financial
hurdles for the devices would only be temporary.

Falk now has two bumps where his forehead meets his hairline, evidence of
the plastic plugs that sealed dime-sized holes in his skull. The surgery was
unpleasant, he said, but his medications have been sharply reduced and the
worst of the tremors are gone.

Everything is simpler now. The Coon Rapids man can use a computer mouse
because his hand doesn't shake like it used to.

"Just getting out of bed is easier," he said.

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