VNS Therapy System: Implant Proves Miraculous for Chronically Depressed

Millions of Americans suffer from depression in some form or another. Treatments for these emotional disorders involve a variety of pharmaceutical products and therapies, and for most, the conventional methods of controlling episodes work very well. But for a great number of people prescription medications and therapies do not seem to offer relief from the chronic depression that can be almost crippling. These people must endure the anguish and frustration that their disorders cause until a radical treatment is unearthed.

That time may be now.

Cyberonics, Inc., a Houston based medical manufacturer, has developed a means for controlling mood swings and debilitating episodes of depression by using a form of electroconvulsive treatment originally intended for epileptics. It is called the VNS Therapy System, and it may just be what the chronically depressed have been searching for.

VNS, or vagus nerve stimulation, relies on mild electrical impulses to stimulate the vagus nerve. The vagus nerve is actually a complex bundle of nerves that threads its way through most of the body. The vagus nerve derives its name from Latin, meaning "wandering". That is what the nerve seems to do as it moves from the region of the medulla oblongata and down through the larger portion of the brain stem. Three major branches of the nerve serve as the conduit for brain impulses to organs in the head, neck, thorax, and abdomen. With connections to the lungs, heart, larynx, esophagus, stomach, pancreas, intestines, even the ears and tongue, the vagus nerve is one of the most crucial neural pathways in the human body.

When damage or abnormalities occur in this nerve, variant forms of epilepsy can manifest themselves. Scientists have long suspected that the vagus nerve is inexorably linked to seizures, common among epileptics. Providing a clear pathway for normal cerebral impulses keeps the occurrence of seizures to a minimum and mild in nature. That was the basis for a pacemaker-like impulse generator. Such generators were effective in patients that were unresponsive to anticonvulsant medications; patients who lose consciousness during a seizure episode; and in patients for whom brain surgery is not a viable alternative. The implant procedure has been highly successful and is becoming a common procedure for physicians around the world.

But now it seems that VNS has another use, one being explored and implemented by researchers at Cyberonics. They have found that the same stimulation therapy so successful in epileptics can dramatically improve the quality of life for chronically depressed patients.

In 2000, Cyberonics began clinical testing of the VNS Therapy System among selected subjects. The results, while controversial to pharmaceutical manufacturers, the insurance industry, and the Food and Drug Administration (FDA), have proven nearly miraculous to recipients of the system. While there were complications reported by some patients, like fibrosis and edema in the neck, the tests concluded that the device and associated therapy were indeed effective in stemming episodes of deep depression. The FDA accepted the results of the clinical trials and approved the general application of the treatment in early 2005, rescinding an earlier edict that more extensive data be submitted prior to official approval. Now the procedure is available in over thirty states across the United States and is gaining acceptance internationally.

The procedure to implant the VNS generator is a simple one, taking about an hour in most cases. Usually done on an outpatient basis, the implantation is a straightforward operation done under general anesthesia. It requires two incisions, one in the left chest area, below the collarbone, and the other in a crease of skin on the left side of the neck. The first incision provides an opening for the placement of the impulse generator. The second provides direct access to the vagus nerve. Small electrodes are placed around the nerve and then are routed via a thin, flexible wire to the generator. The device is then activated and the incisions closed. The incisions heal within two weeks, with very little scarring. Subsequent to the implantation of the device, patients have their generators adjusted by the attending physician during a routine office visit.

The success of the VNS Therapy System has not come easily for Cyberonics. The company has experienced considerable opposition for the development and approval for the device as it pertains to treating chronic depression. The pharmaceutical industry introduced arguments designed to throw doubt on the efficacy of the treatment, and the insurance industry moved to thwart the approval of the treatment in a seeming effort to avoid paying for the implant in policyholders. Factor in a corporate management shakeup- the company's chief executive officer, Robert "Skip" Cummins, and the chief financial officer, Pamela Westbrook, recently resigned, following investigations into questionable accounting practices- and it is apparent that the company has had its share of problems. Still, with newly placed corporate officers, renewed investor confidence, and the approval of the device by the FDA last year, the company shows signs of improved stability. So much so, that billionaire investor Carl Icahn has made a bid to bolster the company's financial interests. While the details of Icahn's full involvement are currently undisclosed, there is no doubt that the mogul responsible for the salvation of troubled ImClone will produce solid growth Cyberonics. Testimony to this supposition can be seen in the jump of company stock values following the announcement of Icahn's involvement.

Even though Cyberonic's new technology gamble provides relief and satisfaction to its core of investors, what truly matters is the relief felt by the patients using the device. Hundreds of patients have received the VNS Therapy System, and each of these people sees the device as a miracle. Many have given testimonials to the fact that VNS has given them back control of their lives and returned to them a happiness that had eluded them for up to 25 years. For most, the device was a last resort, chosen out of desperation after conventional treatments failed. The results have been astounding, with an overwhelming majority of the patients surveyed reporting vastly improved qualities of life. Many of the patients have returned to working full time, and most say that their lives are more fulfilled now, without the burden of depression. And very few of the patients have experienced anything other than the mildest side effects. The most common side effect is a slight to moderate change in a patient's voice because of the nerve stimulation. But it seems that almost none of the patients using VNS technology object to the change in their voices. As one patient, Cathy, put it, "So my voice gets goofy a couple of times a day. Who cares?" She adds, "I now have my life back."

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For additional information on the VNS Therapy System, visit www.vnstherapy.com.