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Thursday, May 30, 2013

CMS Says 'No' to Vagus Nerve Stimulation for Depression

CMS Says 'No' to Vagus Nerve Stimulation for Depression

Caroline Cassels

May 30, 2013
Medicare patients with treatment-resistant depression will not have access to vagus nerve stimulation (VNS) therapy, according to a recent decision by the Centers of Medicare and Medicaid Services (CMS).

In a company release, the VNS device manufacturer, Cyberonics, Inc., announced that the CMS had declined its request for approval and stated it was "very disappointed in the position taken by CMS that new evidence accumulated over the past 5 years and recently published in 4 peer-reviewed journals does not support reconsideration of the non-coverage decision."

"We believe the total body of evidence that began appearing in the scientific literature in 1998 presents compelling rationale for access to VNS therapy in a very ill subpopulation of Medicare beneficiaries," Cyberonics' president and CEO Dan Moore said in the company release.

"The company plans to work with other interested parties to continue to pursue access to this important therapeutic option for patients who could benefit from VNS Therapy, including carefully evaluating all options for appealing this decision," Moore added.

The VNS Therapy System has been approved by the US Food and Drug Administration for the treatment of refractory epilepsy and treatment-resistant depression.


Doctor claims $200M in damages from Cyberonics

May 29, 2013, 11:53am CDT Updated: May 29, 2013, 12:11pm CDT

Doctor claims $200M in damages from Cyberonics

Cyberonics is involved in an ongoing dispute with a doctor about royalty payments.
Reporter- Houston Business Journal
A Miami Beach, Fla. doctor claims Houston-based Cyberonics Inc. (Nasdaq: CYBX) owes him $200 million in damages and $613,000 for unpaid royalties, according to regulatory filings.

Although Dr. Jacob Zabara's complaints against Cyberonics date to 2012, this is the first time he has allotted a value to the alleged damages.

The medical device company said in a May 28 regulatory filing that Zabara alleges he is entitled to royalties on products that use his patents, which were licensed to the company under a 1988 license agreement.

Zabara initially inquired about his royalty payments in 2012 in a letter, his attorney, William Helfand of Houston's Chamberlain Hrdlicka, told Houston Business Journal.

"In response to his inquiry about why he wasn’t being paid his royalties, this company sued him seeking a ruling of the court that it did not owe him," Helfand said.

Cyberonics filed a lawsuit in the U.S. District Court Southern Division of Texas against the doctor in April last year, seeking a declaration that Zabara is not entitled to any royalties.

"Dr. Zabara has been paid tens of millions of dollars of royalties since the inception of the license," according to Cyberonics' original complaint. "In July 2011, however, that royalty stream ended as the original patents expired. No further royalties are due for Cyberonics' current devices."

Helfand disagrees, however, and said "payments were not properly calculated." In addition, Helfand alleges the company did not comply with a requirement to market some of Zabara's other inventions.

Earlier this month, a district court ruled Cyberonics breached the license agreement by "failing to pay the $9,000-per-quarter minimum royalty since July 2011," according to a regulatory filing.

A trial in the dispute over the agreement has been set for June 10.

Wednesday, May 29, 2013

What is the role of brain stimulation therapies in the treatment of depression?

Curr Psychiatry Rep. 2013 Jul;15(7):368. doi: 10.1007/s11920-013-0368-1.

What is the role of brain stimulation therapies in the treatment of depression?


Campbell Family Research Institute, Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, 1001 Queen St. W. Unit 4, Room 115, Toronto, ON, M6J 1H4, Canada,


Brain stimulation therapies have demonstrated efficacy in the treatment of depression and treatment-resistant depression (TRD). Non-invasive brain stimulation in the treatment of depression has grown substantially due to their favorable adverse effect profiles. The role of transcranial direct current stimulation in TRD is unclear, but emerging data suggests that it may be an effective add-on treatment. Repetitive transcranial magnetic stimulation has demonstrated efficacy in TRD that is supported by several multicenter randomized controlled trials. Though, vagus nerve stimulation has been found to be effective in some studies, sham controlled studies were equivocal. Electroconvulsive therapy (ECT) is a well-established brain stimulation treatment for severe depression and TRD, yet stigma and cognitive adverse effects limit its wider use. Magnetic seizure therapy has a more favorable cognitive adverse effect profile; however, equivalent efficacy to ECT needs to be established. Deep brain stimulation may play a role in severe TRD and controlled trials are now underway.
[PubMed - in process]

NDI Medical launches spinoff to optimize deep brain stimulation for Parkinson’s disease

NDI Medical launches spinoff to optimize deep brain stimulation for Parkinson’s disease

May 28, 2013 3:53 pm by | 0 Comments

deep brain stimulation st. jude medical
Photo from St. Jude Medical
In the decade since the FDA cleared the first deep brain stimulation device to treat symptoms of Parkinson’s disease (Medtronic’s Activa), it’s become established a safe, effective option along the spectrum of care. But Geoff Thrope, the founder and managing director of venture and commercialization firm NDI Medical LLC, said that technology hasn’t changed much since it first came out.

Now, as other companies advance me-too deep brain stimulation devices in the U.S. and bring them to market in other countries (read: St. Jude Medical and Boston Scientific), there’s a market opportunity for technology that can make the newer devices different and better.

NDI has spun off a new portfolio company, Deep Brain Innovations, to do just that. CEO Thrope said NDI has been working with Warren Grill, a professor of biomedical engineering at Duke University, over the past several years to identify needs of clinicians that weren’t being met by existing DBS technology. Thrope said they saw two big opportunities: making the devices more efficient, so that their batteries would last longer, and improving their performance.

DBS devices comprises electrodes, leads and a pulse generator that are implanted in patients. They deliver electrical pulses to targeted areas of the brain to block electrical nerve signals that generate PD symptoms like tremor, stiffness, slowed movement and walking problems. Clinicians program a “dose” of therapy by selecting the amplitude of stimulation delivered, the duration of the pulse and the frequency of stimulation.

Grill – also the company’s chief scientific officer – has developed a fourth dimension, enabling clinicians to control what he calls the temporal pattern of stimulation, or the pattern of time between the pulses. Using computer models and engineering methods, he design patterns of stimulation,like Morse code, that maintain the device’s efficacy while making it more efficient. Deep Brain Innovations, then, thinks it can use that technique to improve the longevity of implanted DBS devices and reduce replacement-related risks and costs.

Over the last few years, the team has done a series of clinical studies with thought leaders at Duke University, Emory University and Wake Forest Baptist Medical Center that have demonstrated effectiveness of the technique, Thrope said. Now, Deep Brain Innovations is looking to secure a commercial partner with which it can run a final clinical trial, complete the regulatory process and bring the device to market within the next 24 months.

“Now what you can do is modify (a device’s) pattern through software, whether that’s with technology already on the market or a company that’s bringing a new product into the marketplace,” Thrope said. “We should be able to accelerate the process of delivering this particular new therapy into the marketplace in a much more efficient manner that if you were coming up with a totally new therapy.”

Formed in 2012, Deep Brain Innovations is the latest spinoff of NDI, which invests in and develops neurostimulation technologies in large markets where there’s at least one validated product but where needs still exist. The global market for neurostimulation devices is expected to grow rapidly, reaching $6.8 billion within three years.

NDI has also spun out SPR Therapeutics, which is commercializing a device for shoulder pain in post-stroke patients, and Checkpoint Surgical, a device to help doctors locate nerves during operations. The last product Thrope and Grill worked on together, a bladder pacing system called MedStim, was acquired by Medtronic for $42 million in 2008.


Deep Brain Stimulation: Evidence Based Science or Wishful Thinking?

Deep Brain Stimulation: Evidence Based Science or Wishful Thinking?

By Natalie Timoshin, Managing Editor | May 28, 2013

I have a friend whose nephew received a diagnosis of late stage cancer about 9 months ago—everyone thought (but didn’t say) his chances for survival were slim. After stem cell transplantation, he’s just marked 100 days of being cancer free.

Cancer outcomes like this make me optimistic for the future. Deep brain stimulation (DBS) might be another reason to feel optimistic about the future.

One of my favorite sites on the internet is Ted Talks. I don’t spend a lot of time on the internet, but I do have a few favorites (eg, New York Times, Psychiatric Times, the National Gallery of Art), and Ted Talks tops this list. The topics are varied and I learn something new every time: I recently learned how to tie my shoelaces so that they don’t untie and had my future brightened by Andres Lozano, MD, PhD, who talked about Parkinson, depression, and ways that their processes might be turned off.

Because of new imaging techniques and advances in our understanding of neurophysiology, neurological and psychiatric disorders are increasingly being recognized as disorders of circuit functions in the brain. Using techniques such as DBS, neurosurgeons are able to pinpoint malfunctioning circuits and to recalibrate them. DBS is very precise—the electrode is inserted through the skull and into any area of the brain to deliver electricity.

Dr Lozano is chief of neurosurgery at the University of Toronto, where he and his team are studying the use of DBS to turn brain circuits on and off, depending on the circuits’ role in certain disorders (eg, movement, mood, memory). In his presentation on Ted Talk, Lozano describes the case of a little boy with dystonia who is no longer able to stand or walk and whose prognosis is dismal—he will be progressively more disabled and his chances of survival are nil. Dr Lozano and his team used DBS to suppress the circuits in his brain responsible for movement. Three months later the boy is walking. As a young adult he is living a normal life and going to university.

Both pharmacological and psychotherapeutic modalities are used to treat MDD, yet 10% to 20% of patients with depression do not respond to treatment. PET scans have shown that areas of the brain responsible for motivation, drive, and decision making are impaired in patients with severe depression, and the sadness center is overactive. After six months of continuous DBS, the sadness center is turned off, and the circuits responsible for motivation, drive, and decision making have made a comeback.

Similar positive results were seen when DBS was used in patients with early Alzheimer disease. Healthy brains use 20% of the body’s supply of glucose—as Alzheimer disease progresses, glucose utilization shuts down. Dr Lozano and his team wanted to know if this “power failure” could be reversed. They placed DBS electrodes in the Fornix area of the brain and looked at what happened to glucose consumption. After one month, areas of the brain that had stopped using glucose had resumed consumption. The implications seem to be that not only can DBS modify symptoms but that the technique can help repair damaged areas of the brain as well.

Is DBS evidence-based science or wishful thinking? What do you make of the different brain stimulating techniques? Is there reason for my optimism? Can I continue to believe that my golden years will not be plagued by memory loss and cognitive decline?

Oh, my friend’s nephew . . . he celebrated by getting engaged!
For Release Tuesday, May 28, 2013; 5:30 PM ET

HOUSTON, May 28, 2013 -- Cyberonics, Inc. (NASDAQ:CYBX) today announced the receipt of a letter from the Centers of Medicare and Medicaid Services (CMS) declining the company’s request to reconsider the 2007 National Coverage Determination for the treatment-resistant depression indication.  

"Cyberonics is very disappointed in the position taken by CMS that the new evidence accumulated over the past five years and recently published in four peer-reviewed journals does not support reconsideration of the non-coverage decision. We believe the total body of evidence that began appearing in the scientific literature in 1998 presents compelling rationale for access to VNS Therapy in a very ill subpopulation of Medicare beneficiaries," said Dan Moore, Cyberonics’ President and Chief Executive Officer.

 "The company plans to work with other interested parties to continue to pursue access to this important therapeutic option for patients who could benefit from VNS Therapy, including carefully evaluating all options for appealing this decision."

The company will provide additional information at its previously-announced financial results conference call on June 5, 2013. 

About Cyberonics, Inc. and the VNS Therapy System
Cyberonics, Inc. is a medical technology company with core expertise in neuromodulation. The company develops and markets the VNS Therapy system, which is FDA-approved for the treatment of refractory epilepsy and treatment-resistant depression. The VNS Therapy system uses an implanted medical device that delivers pulsed electrical signals to the vagus nerve. Cyberonics markets the VNS Therapy system in selected markets worldwide.

Safe harbor statement
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. These statements can be identified by the use of forward-looking terminology, including "may," "believe," "will," "expect," "anticipate," "estimate," "plan," "intend," "forecast," or other similar words. Statements contained in this press release are based on information presently available to us and assumptions that we believe to be reasonable. We are not assuming any duty to update this information if those facts change or if we no longer believe the assumptions to be reasonable. Investors are cautioned that all such statements involve risks and uncertainties, including without limitation, statements concerning appealing CMS’s decision not to reconsider the 2007 NCD and obtaining a positive coverage determination from CMS for VNS Therapy in patients with treatment-resistant depression. Our actual results may differ materially. Important factors that may cause actual results to differ include, but are not limited to: continued market acceptance of VNS Therapy and sales of our products; the development and satisfactory completion of clinical trials and/or market test and/or regulatory approval of new products, including VNS Therapy for the treatment of other indications; satisfactory completion of the post-market registry required by the U.S. Food and Drug Administration as a condition of approval for the treatment resistant depression indication; adverse changes in coverage or reimbursement amounts by third-parties; intellectual property protection and potential infringement claims; maintaining compliance with government regulations and obtaining necessary government approvals for new products and indications; product liability claims and potential litigation; reliance on single suppliers and manufacturers for certain components; the accuracy of management's estimates of future expenses and sales; the potential identification of material weaknesses in our internal controls over financial reporting; and other risks detailed from time to time in our filings with the Securities and Exchange Commission (SEC). For a detailed discussion of these and other cautionary statements, please refer to our most recent filings with the SEC, including our Annual Report on Form 10-K for the fiscal year ended April 27, 2012 and our Quarterly Report on Form 10-Q for fiscal quarters ended July 27, 2012, October 26, 2012 and January 25, 2013.

Additional information about Cyberonics and the VNS Therapy system is available at  

Contact Information
Greg Browne, CFO
Cyberonics, Inc.
100 Cyberonics Blvd.
Houston, TX 77058
Main: (281) 228-7262
Fax: (281)  218-9332

Tuesday, May 28, 2013

Epilepsy Device Pioneer Cyberonics Still Evolving After 25 Years

Epilepsy Device Pioneer Cyberonics Still Evolving After 25 Years
Bernadette Tansey    5/28/13      Follow@tanseyverse 
Long before the explosion in the personal electronics field brought us iPods and iPhones, biomedical engineers were making devices to interact with the personal electrical “circuitry” that regulates the human heart and other organs. Back in 1958, Minneapolis, MN-based Medtronic produced its first battery-operated, portable pacemaker to stimulate nerves in the malfunctioning heart. It looked something like an old Sony Walkman cassette player strapped around the waist.

In 1987, Texas entrepreneurs founded a company to try a nerve stimulation device as a treatment for epilepsy. The units now marketed by that company, Houston, TX-based Cyberonics (NASDAQ: CYBX) still have the same basic design: a surgeon implants a unit called a generator under the skin of the upper chest, then threads an electrode from the generator up through the side of the neck. The thin wire, wrapped around the vagus nerve, delivers mild electrical pulses designed to head off seizures. The device is supposed to reduce the frequency of epileptic seizures.

The size of Cyberonics’ generator unit, however, has changed since the first model was approved by the FDA in 1997.

Cyberonics CEO Daniel Moore keeps one of the company’s first models on his desk.

“People say it was the size of a hockey puck,” Moore says. “It wasn’t quite that big.”

Recent improvements in battery technology have allowed Cyberonics to shrink the devices it sells today to the size of a watch face, Moore says. And, like pacemaker manufacturers, Cyberonics has been working to make its Vagus Nerve Stimulation (VNS) Therapy system more responsive to individual needs. The company is also tapping the interactive potential of the units as collectors of data for patients and their physicians.

The latest round of technical improvements come as Cyberonics has largely recovered from a big setback a few years ago. The company hit a low point in May 2007, when Medicare said there wasn’t enough evidence to support use of the Cyberonics device for patients with treatment-resistant depression. The company saw its sales drop 8 percent the following year, before it regained its momentum in 2009, with renewed focus on epilepsy. Sales climbed about 15 percent last year to $218.5 million.

The Texas firm faced no clear competitors when it began developing its implantable units for epilepsy in the 1980s. It was a different situation than the one faced by Medtronic in 1958. Back then, the Minneapolis company’s portable, external cardiac pacemaker helped heat up a race to market the first pacemaker that could be implanted in the body—which Medtronic (NYSE: MDT) did in 1960.
The first task for Cyberonics was to persuade doctors and the FDA that its implantable VNS device had a place in the epilepsy treatment spectrum.

In the United States, nearly 3 million people have epilepsy, according to the Epilepsy Foundation, a non-profit patient support group. About half of those diagnosed can get seizure relief from the first drug prescribed, Moore says. If not, doctors try one medicine after another, alone or in combinations, to find a regimen that works. For two-thirds of patients, drugs will curb the disorder, Moore says. But that leaves a substantial population whose seizures aren’t fully controlled. Cyberonics estimates that about 400,000 people in the United States are candidates for its product.

The company’s VNS devices usually deliver a 30-second electrical pulse to the vagus nerve about every five minutes, but the timing and strength of the electrical burst is programmed by a doctor using a handheld computer. The National Institute of Neurological Disorders and Stroke estimates that the therapy reduces the frequency of seizures by an average of 20 to 40 percent. Patients with the device keep taking anti-epilepsy medication, but they may be able to reduce the dose.

In 1997, Cyberonics’ device was approved in the United States for people over the age of 12 who suffer from partial seizures that resist drug treatment. Partial seizures arise in a specific area of the brain, rather than across the whole brain.

The epilepsy device was generating more than $100 million in annual revenues by 2007. But that was a rocky year. Cyberonics had spent millions on R&D to prove that the VNS system could also be effective in depression that doesn’t respond to existing drugs, a potentially larger market than epilepsy. The FDA had approved the device in 2005 for people whose depression was resistant to drug therapy. But Medicare administrators decided in 2007 not to reimburse for the device after reviewing evidence on its benefits and patients’ needs.

At that point, Moore says, the company was losing more than $50 million a year and held $132.5 million in debt. Dissident Cyberonics shareholders, backed by activist investor Carl Icahn, pressured the company to replace three board members. Cyberonics then brought in Moore, a veteran executive from Boston Scientific, as its new CEO.

Moore refocused the company on expanding its epilepsy franchise in the United States and internationally. About 19 percent of sales now come from 70 countries worldwide. Cyberonics, with 570 employees, has been profitable since 2009. The company has paid off the $132.5 million in obligations that burdened it in 2007.

“That debt is gone,” Moore says.

Cyberonics has continued to run clinical trials in depression, and recently re-submitted its case for reimbursement to the Centers for Medicare & Medicaid Services (CMS).

Epilepsy, therefore, still accounts for most sales of the VNS device. Of the approximately 125,000 people newly diagnosed with epilepsy in the United States, about 15,000 to 24,000 are potential candidates for the Cyberonics product, Moore says. That gives the company room for expansion—it treats about 4,000 new U.S. patients a year.

Meanwhile, Cyberonics has been working on successive generations of its device to adapt the technology to individual patients’ needs. Although the VNS device can reduce seizures to some extent through a scheduled series of electrical bursts, an attack can begin between these intervals. Cyberonics provides a supplementary handheld magnet that patients can sweep over the implanted generator in their chests to initiate a pulse when they feel a seizure coming on.

Batteries in the devices are now smaller, and some units can turn themselves off between pulses to prolong battery life. The battery’s life span is important because the generator must be replaced by another surgery when the battery runs down. Batteries now last about three to eight years, depending on the pattern of use for the individual patient, Moore says.

The sixth generation VNS device, AspireSR, is now in development. It is designed to monitor the patient’s heart rate for signs that a seizure may be beginning, and fire off a pulse in response.

Cyberonics is also working on a number of new features, including rechargeable batteries and a device called ProGuardian—an external heart rate monitor to alert patients or their caregivers of impending seizures. Another product in development called Relay would wirelessly transmit data about the patient to a doctor’s computer.

But meanwhile, competitors are also innovating. Cyberonics’ main competition comes from existing anti-epilepsy drugs and new medicines in development, according to its annual report. But rivals are also emerging among device makers. Seattle-based NeuroVista, for one, is developing a device that can provide advance warning to patients about an oncoming epileptic seizure, so they can find a safe place to lay down.

Cyberonics’ forerunner in neuromodulation, the medical device giant Medtronic, has tested its own device for epilepsy. Medtronic has been expanding the market for its Deep Brain Stimulation (DBS) Therapy, which is now FDA-approved for the treatment of Parkinson’s disease, essential tremor and other conditions. In 2010, Medtronic received clearance from regulators to sell the device in Europe, to treat adults with partial-onset seizures that drugs can’t fully control. An FDA panel recommended approval, with some conditions. But the U.S. regulatory agency asked Medtronic to conduct another pre-market study before giving it the green light to sell the device here. Medtronic is in discussions with the FDA on other routes to make the therapy available in the U.S.

Two other companies have gotten European regulatory clearance for their own vagus nerve stimulation devices: CerebralRx of Israel, and Neurotech , which was acquired in November by Sorin Group of Milan, Italy. In February, an FDA panel recommended approval of an anti-epilepsy device made by Mountain View, CA-based NeuroPace. Its RNS System consists of electrodes in the brain that detect abnormal electrical activity and respond with electrical impulses.

Three other companies are working on various non-invasive neuromodulation technologies to treat epilepsy, depression, or both—without implanting a device in the body. Two are US-based: NeuroSigma of Los Angeles, CA, and Neuronetics of Malvern, PA.

Cyberonics has an alliance with the third: CerboMed, a private company based in Erlangen, Germany. Its NEMOS t-VNS system, which includes an earplug-like device, is designed to stimulate a branch of the vagus nerve in the outer ear by sending a pulse through the skin. CerboMed’s device has received clearance for marketing in Europe for patients with epilepsy, depression, and pain. In September, Cyberonics said it had made an initial investment of about $2.6 million in Cerbomed and gained an exclusive option to market the NEMOS device worldwide as an epilepsy treatment.

That said, Cyberonics’ products still dominate the market in devices for epilepsy.

In December, as Cyberonics celebrated its 25th anniversary as a company, it announced that a total of 100,000 of its VNS devices had been implanted.

Moore says the company’s turnaround since 2007 owed much to the progress the company had already made.

“It was possible because there were so many good people here, and a good product,” Moore says.

Bernadette Tansey is a freelance journalist based in Berkeley, CA. Follow @tanseyverse

Friday, May 24, 2013

TMS for Resistant Depression: Long-term Results Are In

TMS for Resistant Depression: Long-term Results Are In

Caroline Cassels

May 24, 2013
SAN FRANCISCO — Transcranial magnetic stimulation (TMS) appears to offer long-term efficacy in patients with treatment-resistant major depressive disorder (TR-MDD), new research shows.

Presented here at the American Psychiatric Association's 2013 Annual Meeting, the multicenter, longitudinal, naturalistic, observational study showed that acute TMS induced "statistically and clinically meaningful response and remission" in patients with TR-MDD during the acute phase, and that the results were maintained at 52 weeks.

"This is the first study to examine 12-month outcomes of TMS in a large dataset in a real-life setting. We have data on 257 patients that got all the way through the long-term follow-up, and we found that 68% improved and 45% had complete remission at 1 year follow-up," study investigator Linda L. Carpenter, MD, assistant professor, Department of Psychiatry and Human Behavior, Brown University School of Medicine, and chief, Mood Disorders Program, Butler Hospital, in Providence, Rhode Island, told Medscape Medical News.

"I think this will really be impressive for confirming the long-term durability of this effect to potential payers. This is exciting times for psychiatrists and patients, who have a new treatment option to pursue," she added.

Previous research has shown that TMS is a safe and effective acute treatment option for patients with TR-MDD. However, the long-term efficacy and durability of the treatment in this patient population were unclear.

To assess the changes in depressive symptoms and functional capacity across the duration of acute and long-term follow-up of TMS treatment, the investigators studied 307 depressed patients who were part of a prospective multicenter observational clinical trial examining the utilization and outcomes of the NeuroStar TMS Therapy System (Neuronetics Inc, Malvern, Pennsylvania).

Study participants had a primary diagnosis of unipolar, nonpsychotic major depressive disorder and had failed to receive benefit from prior antidepressant treatment. The mean age of the participants was 48.6 ± 14.2 years, and 66.8% were women.

The study's primary outcomes included Clinical Global Impressions–Severity of Illness Scale (CGI-S), Patient Health Questionnaire (PHQ-9), and the Self-Rated Inventory for Depression Symptomatology (IDS-SR).

All patients initially received the standard simulation protocol (120% of motor threshold, 10-Hz cycles of 4 seconds of active stimulation followed by 26 seconds of no stimulation for a total of 3000 pulses per treatment session), but this could change to meet patient needs. Treatment was received daily for a period of 4 to 6 weeks.

Real-world Study
Of the total study population, 264 patients (62%) from 42 clinical practices achieved symptomatic improvement, and 41% reported complete remission with acute treatment.

Of these individuals, 257 entered a 12-month long-term follow-up phase of the study, in which they were tapered off of the acute treatment regimen and were observed for 52 weeks.

Outcome measures were obtained at 3, 6, 9, and 12 months. Concurrent medication use and TMS reintroduction for recurrent symptoms were recorded and summarized during the long-term follow-up.

At 12 months, 68% of patients achieved symptomatic improvement, and 45% reported complete remission. Maintenance of benefit was observed under a pragmatic regimen of continuation antidepressant medication and access to TMS reintroduction for symptom recurrence.

The researchers report that compared with baseline, there was a statistically significant reduction in mean (standard deviation [SD]) CGI-S, PHQ-9, and IDS-SR total scores at the end of acute treatment (5.1 [0.9] vs 3.2 [1.5]; 18.3 [5.2] vs 9.6 [7.0]; and 45.7 [11.0] vs 27.4 [15.8]; all P < .0001), which was sustained throughout the 52-week follow-up period (3.0 [1.5], 9.4 [7.2], and 27.3 [16.1], respectively; all P < .0001).

"The durability of NeuroStar TMS Therapy demonstrated by this robust, real-world study is remarkable, as it's not typical to see long-term benefit in patients who have treatment-resistant forms of depression," study investigator Philip Janicak, MD, professor of psychiatry, Rush University Medical College, and medical director of the Rush Psychiatric Clinical Research Center, in Chicago, said in a statement.

"Great News"
Asked by Medscape Medical News for independent comment on the study, Mark George, MD, professor of psychiatry, radiology, and neurosciences and director of the Medical University of South Carolina Center for Advanced Imaging Research as well as the Brain Stimulation Laboratory in Charleston, said that the study is good news for clinicians and patients alike.

Dr. George's group was the first to publish a study on TMS and depression in 1994, and he has been actively investigating the technology since that time.

He also led a large National Institutes of Health study, published in 2010, showing that repetitive daily TMS produced statistically significant and clinically meaningful antidepressant effects compared with sham treatment in patients with TR-MDD.

"This is a very important and exciting study. Several prior studies have shown that prefrontal rTMS works to treat depression acutely. Until this study, we have had only limited information about how well these patients do a year after completing a course of TMS. Long-term data following remission produced by medications or electroconvulsive therapy [ECT] in these treatment-resistant patients have been disappointing, with only about 13% being still remitted a year later.

"For example, over half of patients who remit with ECT are ill again 6 months later. Thus, having 45% in remission a full year later is very, very encouraging that rTMS is perhaps changing the underlying pathological circuitry associated with depression and producing a more stable remission than the other treatments.

"This is great news for our field and for the millions of patients who suffer from depression and do not respond well to medications," Dr. George added.

Dr. Janicak reports that he has received grant/research support from Janssen-Ortho Pharmaceutica Inc, Neuronectics Inc, Otsuka Pharmaceuticals, and Sunovion Pharmaceutical Inc. Dr. Carpenter reports that she is a consultant for Abbott Laboratories, Johnson & Johnson, and Lundbeck and that she has received grant/research support from NeoSync, Medtronic Inc, Neuronetics, and the National Institute of Mental Health. Dr. Dunner has disclosed no relevant financial relationships. The remaining authors are employees of Neuronetics Inc. Dr. George reports no relevant financial relationships, he reports that he does not take money from TMS manufacturers for speaking or consulting, and he reports that he does not own equity in any device or drug company.
The American Psychiatric Association's 2013 Annual Meeting. Abstract NR12-5. Presented May 21, 2013.

Thursday, May 23, 2013

Implanted device curbs Valpo man's seizures

Implanted device curbs Valpo man's seizures

VALPARAISO | A small scar on the left side of his chest is one of only a few outward signs that John Camacho is not 100 percent OK.

The Valparaiso man, who turns 33 in July, seems to live like an average bachelor.

A framed black-and-white aerial shot of Wrigley Field hangs above the TV in the front room of his one-bedroom apartment. A gray schnauzer-pug mix named Luke follows him from room to room.

But, Camacho cannot work nor drive. Only recently did he start living on his own.

"I might look like I'm 100 percent, but I'm not," he said.

A car crash nearly 13 years ago put him in a coma for two weeks. When he emerged, nothing looked familiar, not even faces of loved ones.

For 2 1/2 years, he re-learned the basics. He took first steps and learned words like "hat" and "television" and "blue."

"I had to learn how to walk, do everything," he said.

Regular seizures interrupted his progress. A bad headache or a wave of sleepiness would signal an approaching seizure. Camacho couldn't be alone the first five years.

"I felt like I had no life," he said.

That changed 14 months ago. After undergoing an hour-long procedure at Methodist Hospitals Southlake campus in Merrillville, Camacho now has a regular stream of electricity pulsing into his brain via a wire device implanted in his chest. It dispenses Vagus Nerve Stimulation, or VNS, therapy.

At the signs of an approaching seizure, he swipes a magnetic bracelet against the device in his chest, and it sends a jolt of electricity to his brain, derailing the seizure.

The technology loosened the tether on his life. He can enjoy the nightlife of downtown Chicago or get dinner with his family and friends without fear of a seizure.

He still cannot drive or work. He keeps busy helping the older people in his apartment complex or playing cards and dice with them.

Camacho believes he survived the accident to help others and to be a sign of hope.

"God kept me here for a reason," he said.

The accident happened when Camacho, driving a friend's car home, nodded off at the wheel. He woke up as the car was about to flip. Camacho recalls he saw St. Michael the Archangel, who told him to go to sleep, as he wrapped Comacho in his wings.

The car hit a tree and wrapped around it. He didn't break any bones and suffered only a small cut on his head. But his brain was damaged.

Camacho doesn't remember the accident and says he went to heaven while he was in a coma. Some doubted he would survive, but Camacho said the 8-foot-tall, muscular St. Michael watched over him at the hospital.

"You can believe it or not," he said. "I just know what I saw."

Camacho said he's always been a people person and enjoyed having fun. Since his accident, his attitude is even more upbeat.

"Rock it out to the fullest," Camacho said. "You never know. Tomorrow, you can be gone."

People are too stressed out, he said.

"They're missing everything," he said.

Tuesday, May 21, 2013

New Data Show Long-Term Benefit of Transcranial Magnetic Stimulation in Difficult-to-Treat Patients with Depression using NeuroStar TMS Therapy System

New Data Show Long-Term Benefit of Transcranial Magnetic Stimulation in Difficult-to-Treat Patients with Depression using NeuroStar TMS Therapy System

Largest clinical study evaluating durability of Transcranial Magnetic Stimulation
(TMS) shows depression patients maintained remission through 52 weeks with the NeuroStar
SAN FRANCISCO, May 21, 2013 /PRNewswire/ -- New data released today at the annual meeting of the American Psychiatric Association show that the NeuroStar TMS Therapy System(R) induced statistically and clinically meaningful response and remission in patients with Major Depressive Disorder (MDD) during the acute phase of therapy, which were maintained through one year of treatment. At the end of acute treatment, 62 percent of patients achieved symptomatic improvement while 41 percent reported complete remission. At 12 months, 68 percent of patients achieved symptomatic improvement while 45 percent reported complete remission. Maintenance of benefit was observed under a pragmatic regimen of continuation antidepressant medication and access to TMS reintroduction for symptom recurrence.

"The durability of NeuroStar TMS Therapy demonstrated by this robust, real-world study is remarkable, as it's not typical to see long-term benefit in patients who have treatment resistant forms of depression," said Dr. Philip Janicak, M.D., Professor of Psychiatry at Rush University, and Medical Director of the Rush Psychiatric Clinical Research Center. "The study reinforces the sustained efficacy of NeuroStar TMS Therapy in a majority of patients with depression who have not found relief through oral antidepressant medication."
With 42 clinical practices participating, 307 patients with a primary diagnosis of unipolar, non-psychotic major depressive disorder, who had failed to receive benefit from prior antidepressant medication, received NeuroStar TMS Therapy.

The objectives of this study were to assess the change in depressive symptomatology and functional capacities across the duration of acute and long-term follow-up treatment with NeuroStar TMS. Of the patient population, 257 patients received benefit with acute TMS treatment, then were tapered from their acute treatment regimen and consented to long-term observation over 52 weeks.

Clinical assessments were based on data obtained at three, six, nine and twelve months using the clinician-rated Clinical Global Impression Severity of Illness (CGI-S), and the patient-rated Patient Health Questionnaire (PHQ-9) and Inventory for Depressive Symptomatology-Self Report (IDS-SR).
Neuronetics, Inc. is building upon the robust clinical profile of NeuroStar TMS Therapy System.

Most recently, Neuronetics initiated an open-label study to evaluate the safety and efficacy of the NeuroStar(R) in patients with MDD who are living with post-partum depression. In addition, Neuronetics is also conducting a randomized study on durability of TMS as a maintenance therapy.
About NeuroStar TMS Therapy System(R) Neuronetics' NeuroStar TMS Therapy System was cleared by the FDA in October 2008 for the treatment of Major Depressive Disorder (MDD).

NeuroStar TMS Therapy is indicated for the treatment of MDD in adult patients who have failed to achieve satisfactory improvement from one prior antidepressant medication at or above the minimal effective dose and duration in the current episode. NeuroStar TMS Therapy is a non-systemic (does not circulate in the bloodstream throughout the body) and non-invasive (does not involve surgery) form of neuromodulation. It stimulates nerve cells in an area of the brain that has been linked to depression by delivering highly-focused MRI-strength magnetic field pulses. The treatment is available by prescription and typically administered daily for 4-6 weeks.

Nearly 500 NeuroStar Systems are now in operation across the U.S. and more than 12,000 patients have received treatment since clearance by the U.S. Food & Drug Administration in 2008. In June 2012, Neuronetics received the CE Mark for the NeuroStar TMS Therapy System.

For full safety and prescribing information, visit

About Depression

Depression is a serious illness that affects about 20 million Americans annually. People with depression may experience a range of physically and emotionally debilitating symptoms, including anxiousness, sadness, irritability, fatigue, changes in sleep patterns, loss of interest in previously enjoyable activities and digestive problems. It is estimated that about four million patients do not benefit from standard treatments for depression, even after repeated treatment attempts.

About the Study

The study was designed to assess the long-term effectiveness of NeuroStar TMS Therapy in a naturalistic clinical practice settings over 52 weeks following a clinically beneficial acute treatment course. The study population spanned 42 clinical practices with a cumulative total of 307 patients with a primary diagnosis of unipolar, non-psychotic major depressive disorder, who had failed to receive benefit from prior antidepressant medication.

NeuroStar TMS Therapy was administered to patients as determined by the evaluating physician, consistent with labeled use. Patients who received benefit from acute NeuroStar TMS Therapy were tapered from their TMS regimen and observed through 52 weeks of follow-up. Clinical assessments (CGI-Severity of Illness, PHQ-9 and IDS-SR) were obtained at three, six, nine and twelve months. Concurrent medication use and TMS reintroduction for recurrent symptoms was recorded and summarized during the long-term follow up.

Compared with baseline, there was a statistically significant reduction in mean [SD] CGI-S, PHQ-9 and IDS-SR total scores at the end of acute treatment (5.1 [0.9] versus 3.2 [1.5], 18.3 [5.2] versus 9.6 [7.0], and 45.7 [11.0] versus 27.4 [15.8], all P<0 .0001="" 27.3="" 52="" 9.4="" all="" and="" follow-up="" p="" respectively.="" sustained="" the="" throughout="" was="" week="" which="">
About Neuronetics, Inc.

Neuronetics, Inc., is a privately-held medical device company focused on developing non-invasive therapies for psychiatric and neurological disorders using MRI-strength magnetic field pulses. Based in Malvern, PA, Neuronetics is the leader in the development of TMS Therapy, a non-invasive form of neuromodulation. For more information, please visit or

NeuroStar(R) , NeuroStar TMS Therapy(R) and TMS Therapy(R) are registered trademarks of Neuronetics, Inc.

SOURCE Neuronetics, Inc.

/CONTACT: Sue McMonigle, Neuronetics, Inc., Office: 610-981-4153, Cell: 215-527-4205,, or Maura Siefring, Tonic Life Communications, Office: 215-928-2346, Cell: 215-837-8450,

Get happy about depression study results

May 21, 2013, 5:01pm EDT

Get happy about depression study results

Senior Reporter- Philadelphia Business Journal
Neuronetics presented new data showing its NeuroStar TMS Therapy System was not only effective in the immediate treatment of patients suffering from depression, but sustained those results through one year of treatment.

“It’s not typical to see long-term benefit in patients who have treatment resistant forms of depression,” said study investigator Dr. Philip Janicak, a professor of psychiatry at Rush University and the medical director of Rush Psychiatric Clinical Research Center.

The study results were presented Tuesday by the Malvern, Pa., company, led by CEO Bruce Shook, at the annual meeting of the American Psychiatric Association in San Francisco.

Get happy about depression study results

Neuronetics’ TMS (transcranial magnetic stimulation) therapy involves the use of a non-invasive therapeutic device to deliver MRI-strength, pulsed, magnetic fields that induce an electronic current in the cerebral cortex — the part of the brain that controls mood.

The study found 68 percent of the patients treated with Neurostar experienced significant improvement in their depression, and 45 percent reported being in complete remission a year later.
The clinical trial involved 42 clinical practices and 307 patients with a primary diagnosis of unipolar, non-psychotic major depressive disorder, whose conditions failed to improve after previously receiving antidepressant medication.

More than 12,000 patients have received treatment from one of the nearly 500 NeuroStar Systems now in operation across country since the therapy was cleared by the Food & Drug Administration in 2008, according to Neuronetics.

In June 2012, Neuronetics received the European Commission approval for the NeuroStar TMS Therapy System.

Brain Imaging Shows How Vagus Nerve Stimulation Improves Symptoms of Depression



Brain Imaging Shows How Vagus Nerve Stimulation Improves Symptoms of Depression

Foundation NARSAD Grantees Charles R. Conway, M.D. and Yvette I. Sheline, M.D. Experts on Depression
Drs. Conway and Sheline
In a study funded in part by the Brain & Behavior Research Foundation, Foundation NARSAD Grantees Charles R. Conway, M.D. and Yvette I. Sheline, M.D., and team found that vagus nerve stimulation (VNS) made positive, long-term changes to the brains of people suffering from major depression. Vagus nerve stimulation works by stimulating the vagus nerve (a nerve that runs from the brainstem to the abdomen) by delivering an electronic pulse for thirty seconds every five minutes. The study included thirteen patients who had major depression over the course of two to twenty years who had not responded to treatment from up to five different antidepressant medications.
Dr. Sheline is well known for her work using brain scans to learn about depression. She conducted breakthrough research in the 1990s using functional magnetic resonance imaging (fMRI) scans to identify structural brain changes in the hippocampus and amygdala in depression that established depression as a brain disease. With a 1998 NARSAD Grant, she went on to use fMRI scans to identify how antidepressants correct abnormal brain function to alleviate symptoms of depression.
In the current study, working with Dr. Conway, study first author and associate professor of psychiatry, Washington University School of Medicine, St. Louis, MO, and team, positron emission tomography (PET) brain imaging scans were used to monitor the treatment’s effects on brain activity in specific regions known to be connected to depression. Each participant had a PET scan before the initiation of VNS stimulation, three months into treatment and at twelve months.
After several months, nine study participants experienced reduced depression symptoms and the researchers found that VNS brought about changes in brain metabolism weeks or even months before patients begin to feel better.
“We saw very large changes in brain metabolism occurring far in advance of any improvement in mood,” says Dr. Conway. “It’s almost as if there’s an adaptive process that occurs. First, the brain begins to function differently. Then, the patient’s mood begins to improve.”

Importantly, the researchers also found that VNS affected other deeper structures in the brain, many of which have high concentrations of brain cells that release dopamine, a neurotransmitter that helps control the brain’s reward and pleasure centers and also helps regulate emotional responses. This supports a growing consensus in the field that problems in dopamine pathways may be particularly important in treatment-resistant depression, explains Conway. And he said the finding that vagus nerve stimulators influence those pathways may explain why the therapy can help and why, when it works, its effects are not transient. Patients who respond to VNS tend to get better and stay better.

The study findings were published online on Feb. 15, 2013 in Brain Stimulation.


Monday, May 20, 2013

Man makes medical history with device to control seizures

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Man makes medical history with device to control seizures

The Dispatch
Published: Monday, May 20, 2013 at 11:52 a.m.

Contributed photo
Toney Kincaid is shown with his wife, Betty. Kincaid has a vagus nerve stimulation implant to control seizures.
Toney Kincaid spends much of his time keeping his grandchildren, whom he once thought he would never see.

He was a ticking time bomb.

Ironically, a watch-like device gave him back his life. And little did he know he would become part of medical history, only the second person in the world to have a vagus nerve stimulation implant and the first person in the world to become seizure free because of it.

The nadir of his existence materialized in 1983 in the cafeteria of the Duracell Battery plant on U.S. Highway 64 where he worked. In front of some 200 coworkers, he began staggering, then convulsing. It wasn't just any seizure he was having. It was a grand mal seizure, the one that is characterized by a loss of consciousness and violent muscle contractions.

From that point, the Lexington native's life spiraled downhill. He lost his job, health insurance, driver's license and self-esteem. He still had his seizures, though — up to 3,000 a month. By 1988, his epilepsy was so out of control that doctors feared he didn't have much time to live.

"When my seizures began in 1983, I did not know how a seizure could take control of my body, and I had no control," remembers Kincaid, who is now 61 and lives in the Holly Grove community. "I would become confused and began to feel my body drawing, then I would lose consciousness. During these years, my family could not understand what was going on with me."

Kincaid's medical problem stemmed from abnormal and poorly formed blood vessels in the brain. Its medical term is arteriovenous malformation.

He had pioneering brain surgery for that in 1970 when he was 20 years old. "That was uncharted grounds back then. They didn't know a lot about it back then," Kincaid explains.

Scar tissue from the surgery resulted in his epidemic of seizures.

In 1984, he connected with fellow Davidson County native Dr. J. Kiffin Penry of Denton, a renowned neurologist and researcher who was in the forefront of efforts to improve medical treatment of epileptics. Penry, a former professor at the Bowman Gray School of Medicine at Wake Forest University, who died in 1996, told Kincaid he had two hard choices. He could become essentially a guinea pig for the fledging clinical research or die.

He choose the former but found no instant results. None of the four types of research drugs quelled his seizures.

"I was at my breaking point after being in research trials for five years, and nothing would control my seizures," says Kincaid, who explains he became virtually homebound. It was difficult to function in public. Many of his friends and acquaintances did not understand his malady and kept their distance. Parents of his children's friends would not allow them to visit.

A crude version of the stimulator was first implanted in animals.

Penry was the first to conduct such clinical tests on humans. "I remember Dr. Penry telling me, 'an old dog can't talk, so we're going to put it in you,'" Kincaid says.

According to Invention and Technology Magazine, the treatment involved implanting a cookie-sized device below the left collarbone, with positive and negative leads threaded up to the vagus nerve, around which were wrapped two platinum-foil coils. The two leads essentially created a closed circuit among battery, wires and nerve, thereby concentrating the current on the nerve better than a single lead and decreasing side effects. Penry used a computer to specify the frequency, strength and duration of the stimulations based on experience and the characteristics of the individual case.

Over nine months, beginning in March 1989, Penry slowly increased the strength of the stimulation he gave Kincaid. July 31,1989, was the first seizure-free day Kincaid could remember, and in January 1990 he had his last seizure.

"It's like a pacemaker for the brain," Kincaid describes.

Cyberonics of Houston, Texas, developed the VNS Therapy System. The treatment option recently hit a milestone of 15 years since FDA approval.

"Without this device I would not be living today," Kincaid says. Over the years he has had a half dozen different implants and two of the three different models of the Cyberonics product. The latest stimulator on the market is about the size of a small pocket watch with an indefinite battery life.

Kincaid plans to upgrade to the newest model in the near future.

"I would not have the ability to be a functional part of society without the device," Kincaid says. "With all my seizures, I had no short-term memory. I was unable to remember my children's names or to read. Everything became entangled. My wife could not leave me unattended."

The life-changing device, Kincaid says, "has given me back my self-respect. I felt useless and not worthy of being a husband or parent. When I was homebound for so long, it seemed there would never be any hope for my seizure disorder."

In addition to Penry, Kincaid says he is also indebted to his wife, Betty. They will celebrate their 40th anniversary this October.

The two often speak at medical conferences about the device.

"When we first started, Cyberonics wanted to hear my wife's side of the story. My seizures devastated our family. Our kids were afraid they would come home and find their daddy dead."

Kincaid says he is in relatively good health, though he has some weakness on his left side, which he attributes to his brain surgery.

He wants those who suffer from epileptic seizures to know about the device and how it can change their lives.

Dwight Davis can be reached at 249-3981, ext, 226 or at

Transcranial magnetic stimulation used for depression treatment

Transcranial magnetic stimulation used for depression treatment

Local doctors use magnets to effectively treat depression

Published  9:49 AM EDT May 20, 2013

DANVERS, Mass. -
Thomasina Bedingfield has battled major depression for 50 years and dealt with endless failed treatments.
"When I was 22, they were giving me tranquilizers,” said Bedingfield.
“She was taking a number of medications, but despite that was still very anxious, having trouble functioning, crying all the time,” said Dr. Barry Ginsberg, chief of psychiatry at Beverly Hospital, a member of Lahey Health.
But thanks to a new treatment called Transcranial Magnetic Stimulation, or TMS therapy, the 71-year-old can finally say she’s happy.
“It involves stimulating a particular area of the brain with a rapidly pulsating, strong magnetic field,” said Ginsberg.
That area, the left, prefrontal cortex, is believed to regulate mood, and when someone's depressed, isn't as active as it should be.
The FDA-approved treatment kicks it back into high gear with magnetic pulses about the strength of an MRI.
“You do see people who've just had a response to TMS that they don't get to anything else,” said Ginsberg.
That includes people like Bedingfield, with major depression who've tried antidepressants without success. According to studies, two out of three feel better and one in three patients are completely symptom-free after six weeks of treatment.
“It’s just as effective, maybe even more effective, for people who are earlier in their course of depression,” said Ginsberg.
In extremely rare cases, TMS therapy can cause seizures, but “that's less than one in every 10,000 treatments,” said Ginsberg.
The most common complaint is a tapping feeling during the 37-minute treatment.
“It’s slightly unpleasant at the first treatment, and after that, it's nothing at all. People oftentimes go to sleep during the sessions,” said Ginsberg.
Treatments initially are five days a week for four to six weeks.
“When I got halfway through, I knew I was better,” said Bedingfield.
Experts say the sky's the limit for this new technology and are researching other uses from weight loss to treating pain disorders and migraines.