Neuromodulation field offers broad new horizons for patients and medical firms

Matthew Taylor always wanted to run, but a future in a wheelchair was more likely.

Stricken with cerebral palsy, Matthew tried all sorts of treatments to loosen his locked limbs. Doctors "released" his hamstrings by cutting them surgically to relax the leg muscles. His hip and pelvis were turned and braced. He even took Botox injections, but relief was short-lived.

By the time Taylor was 12, the notion of implanting a gadget in his body to pump medicine to his spine didn't seem that radical, but the results certainly were. Now 16, he runs cross-country for his high school in Baldwin, Fla. — a metal pump the size of a hockey puck just beneath the skin of his belly.

"I feel like I'm special," said Taylor, standing in his bedroom near his row of running medals. "People put me in the position where I am able to run."

His turnaround stems from a burgeoning area of medical technology called neuromodulation, in which doctors use implantable devices to deliver drugs or electronic pulses directly to the brain or other parts of the body in duress. The array of devices is allowing more patients who suffer chronic pain and disability to enjoy active lifestyles that once seemed unimaginable.

Such treatments are expanding the development of medical devices beyond elderly care and creating some of the fastest-growing markets for medical technology companies.

"The number of diseases that this will impact is the next new frontier," said Thomas Gunderson, a senior analyst with Piper Jaffray & Co.

More than 200,000 patients worldwide have the same drug pump as Taylor. Other small, battery-powered devices have been designed to send electric pulses into the brain to treat ailments such as Parkinson's or other movement disorders. About 100,000 people worldwide receive that treatment, according to Medtronic Inc., the world's largest medical device maker.

"Deep-brain stimulation is the next big thing," said Paul Stypulkowski, senior director of therapy research for Medtronic. "And developing a system … to read brain electrical activity and adjust treatment will be huge."

But emerging demand also puts pressure on device makers, as failures can lead to profound complications for patients.

About 9,000 adverse medical events in the U.S. involved implanted spinal cord stimulators in 2010; 500 resulted in hospitalization. Implantable pumps are among the most common devices to be recalled, according to a review by the federal General Accountability Office.

Medtronic's SynchroMed pump, the same used by Taylor, has been linked to 14 patient deaths over the past 17 years. The Food and Drug Administration (FDA) issued official warnings about that device this past summer.

"It would be hard for me and my family to go back to where I was."

The human body's systems are either chemical or electrical — now doctors and device makers are figuring out how to plug in.

Most neuromodulation devices evolved from pacemakers, as doctors and engineers explored what other ailments could be improved by using an electric pulse. First, it was to deaden pain. Then, as batteries got more powerful and smaller, other uses were explored.

"The role of electricity in medicine goes way back," said Martin Gerber, senior research and development director at Medtronic.

Medtronic recently announced a new system that will collect brain signals as it delivers therapy to treat symptoms of Parkinson's, which afflicts 1 million Americans. The new therapy could eventually lead to technology that allows the device to automatically adjust treatment based on what the brain is telling the device — much as implantable defibrillators now do based on heart rhythms.

The global market for neuromodulation devices is expected to hit more than $7 billion by 2018 — growing at a clip of 14 percent a year, according to Transparency Market Research of Albany, N.Y. That dramatic growth is reflected in the revenues of Minnesota's major medical device companies, which are considered world leaders in this area.

Medtronic's neuromodulation sales — nearly $2 billion — have more than doubled in 10 years. St. Jude reported sales of $423 million in 2012; Boston Scientific, which is based in Massachusetts but employs more than 5,000 Minnesotans, made $367 million.

"How big will this become? I don't know that anybody knows," Gunderson said of the growth potential. "But it's big — $13 billion sounds reasonable to me."

The impact of the technology also is dramatic for some of the 13 million Americans suffering from urinary or fecal incontinence.

Cora Correa of Orlando, Fla., suffered silently from incontinence for years with little hope that anything could be done. She had been diagnosed with multiple sclerosis in 2007, and her neurologist believed that her frequent urges to go to the bathroom were a byproduct of the progression of that disease.

"I felt trapped," said Correa, 42.

A couple of years ago, she decided to try the InterStim implant. Relief — and control — soon followed. The device is small enough, she said, that "I forget that I have it."

A single mother of three, Correa said she has no problem counseling other people who are considering the device — including her daughter.

But, unlike her mother, Bianca Reichard was having problems with urinary retention. Where her mom was going all the time, Reichard was maybe urinating twice a day. She started getting chronic kidney infections and kidney stones.

She started losing her hair and gaining weight, as two years of medication failed to help. Finally, after her 20th birthday, Reichard decided to try the device that was helping her mom.

She had the device implanted last November. She's lost weight and regained her confidence. Her kidneys, she said, "are still horrible" and she still gets infections and kidney stones. But the young nursing student who wants to become a nurse practitioner said she has no second thoughts.

"It gives a lot of people a chance for a normal life," she said.

Despite the awkwardness of her problems, Correa said she's not afraid to talk about them. "God is using us as an example," she said.

"What does this give to me? Opportunity," she said. "Opportunity to enjoy life, to be comfortable."

Developing neuromodulation devices, and discovering what those devices can treat, is not a short process. Device makers face a constant challenge, Stypulkowski said: "How do we make this a more lasting, durable therapy?"

This time, the catheter was full of tiny fractures, allowing the drug to leak short of reaching his spinal cord.

The cause? Taylor had been doing sit-ups. Lots of sit-ups. "He wants a six-pack," his mom explained.

Taylor smiles, admitting he wouldn't mind looking buff, like one of his heroes: Tim Tebow.

Doctors replaced the cracked catheter — and told Taylor to stop doing crunches. But he plans to keep running, he said. "You will never see a runner push as hard as I will push."

Taylor's pump, a SynchroMed model from Medtronic, has been upgraded many times over the years as it has spawned multiple warnings, letters to doctors and design changes.

In addition to those, Medtronic recently announced a safety update related to a 2011 recall, meant to help health care professionals avoid making inadvertent injections of the drug into a patient's body instead of into the pump itself.

Previous problems have dealt with the pump's battery, its motor and its catheter. At least one patient has sued Medtronic over problems.

Dr. Diane Chappuis of Minneapolis is familiar with all of it. She has worked with SynchroMed pumps since her residency in 1996. And she explains the potential positives and problems, and offers this warning:

"This won't make you normal," she says. "It's not a miracle; it's a tool."

The device's safety and durability have been improved over the years, Chappuis said. Still, it seems to get a "bad rap" — despite Medtronic saying that better than 94 percent of the pumps continue to perform well after six years in the body.

Any artificial device placed in the body can fail or become infected, Chappuis said. While she has had to remove pumps because of defect or infection, the vast majority of her patients want to go back to having the device as soon as possible.

"The alternatives are medications or injections," Chappuis said. "And these patients have been through unsuccessful conservative therapy before they had the pump implanted, so there isn't a [better] alternative for them."

Dr. Philipp Aldana remembers Matthew Taylor looking more like a pretzel than an active teenager when they first met.

"Now, he runs better than I do," said Aldana, a pediatric neurosurgeon at the University of Florida-Jacksonville and Wolfson Children's Hospital.

Taylor ran his first 5K within weeks of the drug pump being implanted in his abdomen. A 15K and two half-marathons followed.

While the young man's fine motor skills still need work — his sister Morgan has to help him tie his shoes — his development as a runner is gaining speed. Taylor was recently named to his school's varsity cross-country team for the first time. He ranked fourth out of seven runners.

"His endurance has become amazing," said Taylor's coach, Tim Young.

Taylor has spoken to groups in Minneapolis, Denver and Nashville and has run in fundraisers for hospitals. In July, he ran 70 miles over two weeks at a Nike running camp. Today, he is scheduled to run in the Marine Corps Marathon in Washington, D.C.

Matthew hopes to someday become a motivational speaker. He also prays never to lose this gift he has been given, risks and all.

"It has opened so many doors for me," he said. "Without it, I'd be sitting in a wheelchair right now."