Neurostimulation is a hot market in medical technology growth because it offers a new level of efficacy coupled with low rates of complications and side effects compared with drugs and surgery to treat the same ailments. It's been growing at an average rate of 16% per year since 2007 and a new study due out next week projects growth rates of 14% to 23% for certain technologies through 2012.
"It's a new way of approaching the disease state – a solution that has eluded drugs and surgery," Harry Glorikian, managing partner of consulting firm Scientia Advisors (Cambridge, Massachusetts), told Medical Device Daily. "It doesn't have the baggage that comes with drugs and surgery. It's reversible and moderated unlike surgical options. And it's only become possible now because of the melding of neurobiology and medical device manufacturing."
Scientia, which will release its study analyzing this market on Monday, reports that the fastest growth areas include deep brain stimulation, spinal cord stimulation and sacral nerve stimulation.
"If you look at it from the perspective of the current administration and its view on containing costs and nipping a healthcare problem in the bud, if you can imagine that I can use an electrical device that can alleviate the problem, now you're not chronically on drugs, which have side effects," Glorikian said. "In essence, I've decreased healthcare costs. The comparative effectiveness could be significantly higher compared with chronically taking drugs, the side effects, re-dosing, etc."
The Neurostimulation Market Review report finds that the field is currently dominated by four major players: Medtronic (Minneapolis), St. Jude Medical (St. Paul, Minnesota), Boston Scientific (Natick, Massachusetts) and Cyberonics (Houston). But Glorikian is quick to point out that there's plenty of room on the playing field.
"For example, only 4% of the three million people with chronic pain who are treatable are being treated with spinal cord stimulation, so there's plenty of room for growth," he said.
Scientia valued the U.S. neurostimulation market at $1.4 billion in 2007 and projects it will grow to $2.9 billion by 2012. In 2007, spinal cord stimulation comprised 63% of the $1.4 billion market.
Spinal cord stimulation is used primarily to treat chronic pain. When added to drug therapy, these devices decrease pain by 50%; drug therapy alone decreases pain by 9%, according to the Scientia report, which was derived through industry analysis and physician interviews.
"This is definitely no cure, but you can potentially mask the disease state and restore quality of life," Glorikian said.
But would neurostimulation ever supplant pharmaceuticals to treat nerve disorders?
"Right now this segment is treating an extremely small group of people. Neurostimulation won't do away with all drugs. If you have a headache, you'll take Tylenol," he said. "But chronic pain is a different thing. The drawback for drugs for chronic pain include addiction, efficacy and a lot of other problems. But even in the face of all of these drawbacks, if somebody has enough chronic pain, they will eat a fist-full of pills. We think this is the area that will be affected the most. Contrast drugs against neurostimulation: It's a small procedure. Once the switch is flipped, patients report a buzzing feeling in places of pain and the power is adjusted. If it's done correctly, you get a near total block of pain. In the mean time, the patient is free of drug side effects."
The other two largest segments of the market, deep brain and sacral nerve stimulation make up 12% and 13% of the entire neurostimulation market respectively.
Deep brain stimulation (DBS) delivers electrical impulses to targeted areas of the brain via implanted leads and power sources. The report reveals that DBS is used in treating 6% of the approximately six million patients in the U.S. who have movement disorders such as Parkinson's disease, essential tremor and dystonia. DBS also is in the pipeline for use in epilepsy, migraine, major depression, paralysis from stroke and muscular and cognitive disorders.
Sacral nerve stimulation is typically used as a last resort to treat serious bladder or fecal incontinence. In the U.S. alone, 13 million people suffer from serious incontinence and since 1997, about 50,000 have been treated with implanted SNS devices worldwide, according to the report.
Glorikian noted that Medtronic is the only company with an FDA-approved product for clinical use indications for cognitive disorders such as obsessive compulsive disorder. Medtronic's Reclaim was given an FDA humanitarian device exemption for severe OCD earlier this year. (MDD, Feb. 20, 2009). This area, too, has the potential for a large patient population.
"Studies on efficacy are still needed, but it looks extremely promising," he said, adding that all the different disease segments need more studies to prove efficacy and ease of use.
"Right now physicians are very familiar with a drug prescriptions," he said. "But this whole Frankenstein thing of using electrodes and turning the screw to treat patients instead of writing a prescription is unfamiliar. But as new studies get introduced, we see it as a much easier route than taking drugs chronically."
A slew of hurdles arise whenever a new technology pushes forward. One that's front and center for these devices, particularly implanted neurostimulators, is battery life. Batteries typically last just four to five years and require recharging or replacement. But Glorikian sees that problem being solved over time as battery technology advances, ultimately opening the door to even more opportunity and a wider patient population.
Experts in the neurotechnology sector have debated about the ethics of devices that could change the mental state. Some have even raised concerns about the need to restrict uses of neurotechnology since it could probe or alter mental states.
Glorikian argued that the side of effects of many drugs to treat neurological conditions are "not insignificant."
"I think that, as we get to know neurobiology and neuromechanicals better, I think we can help with those side effects more than we do today. Right now we're still learning. That said, there are a lot of people that end up taking drugs and their mental state gets changed, i.e. children who take antidepressants and then are driven to suicide. As these devices get more precise, we can mitigate some of those side effects."
And although Glorikian is unaware of any moves to enhance FDA review of neurostimulation devices, "Getting devices through the regulatory process has always been easier than for a drug. But as you get more pharmaceutical-like clinical results, there may be a shift at the FDA."
Despite these issues, Glorikian and his report predict positive outcomes for patients and device makers.
"Neurologists are very excited," he said. "It can really change some people's lives much more effectively than popping a pill. From the manufacturers perspective, there is opportunity to consider these unmet needs. There's an opportunity to get into a growth area when it's still quite nascent."
Lynn Yoffee, 770-361-4789; firstname.lastname@example.org