October 31, 2011

Cyberonics Receives FDA Approval for Expansion of MRI Use With VNS Therapy® Systems

HOUSTON, Oct. 31, 2011 /PRNewswire/ -- Cyberonics, Inc. (NASDAQ:CYBX), a global leader in medical devices for the treatment and management of epilepsy, today announced that the U.S. Food and Drug Administration ("FDA") approved a significant expansion of options for Magnetic Resonance Imaging ("MRI") use by patients who have the VNS Therapy System.
The expansion includes:

• New: All cylindrical MRI scanners with magnetic field strengths of 3.0 and 1.5 Tesla; Previous: GE Signa 1.5 Tesla scanner only
• New: Imaging of head and extremities, including knees, using transmit/receive coils; Previous: head imaging only using transmit/receive coils

"This approval will enable VNS Therapy System patients to obtain access to the faster, higher resolution imaging available with 3.0 Tesla MRI scanners," commented Dan Moore, Cyberonics' President & Chief Executive Officer. "Our VNS technology, coupled with this approval, provides physicians with expanded imaging options for patients with epilepsy.
"We are pleased that the FDA has been responsive to patient needs and granted this approval."

http://ir.cyberonics.com/releasedetail.cfm?ReleaseID=619246

Aust N Z J Psychiatry. 2011 Nov;45(11):923-938.

The emerging use of brain stimulation treatments for psychiatric disorders.

Fitzgerald PB.

Source

Monash Alfred Psychiatry Research Centre, The Alfred and Monash University School of Psychology and Psychiatry , The Alfred, First Floor Old Baker Building, Commercial Road, Melbourne, Victoria, 3004 , Australia.

Abstract

Objective: The aim of this study was to review the current state of development and application of a wide range of brain stimulation approaches in the treatment of psychiatric disorders. Method: The approaches reviewed include forms of minimally invasive magnetic and electrical stimulation, seizure induction, implanted devices and several highly novel approaches in early development. Results: An extensive range of brain stimulation approaches are now being widely used in the treatment of patients with psychiatric disorders, or actively investigated for this use. Both vagal nerve stimulation (VNS) and repetitive transcranial magnetic stimulation (rTMS) have been introduced into clinical practice in some countries. A small body of research suggests that VNS has some potentially long-lasting antidepressant effects in a minority of patients treated. rTMS has now been extensively investigated for over 15 years, with a large body of research now supporting its antidepressant effects. Further rTMS research needs to focus on defining the most appropriate stimulation methods and exploring its longer term use in maintenance protocols. Very early data suggest that magnetic seizure therapy (MST) has promise in the treatment of patients referred for electroconvulsive therapy: MST appears to have fewer side effects and may have similar efficacy. A number of other approaches including surgical and alternative forms of electrical stimulation appear to alter brain activity in a promising manner, but are in need of evaluation in more substantive patient samples. Conclusions: It appears likely that the range of psychiatric treatments available for patients will grow over the coming years to progressively include a number of novel brain stimulation techniques.

PMID:

22044172

[PubMed - as supplied by publisher]

http://www.ncbi.nlm.nih.gov/pubmed/22044172

New Data Suggests VNS Effective in Managing Depression in Everyday Practice

on February 11, 2011 | Permalink | Comments (0)

Topics: Service Lines, Neurosciences

A study released earlier this week from the University of Pennsylvania School of Medicine demonstrated that Vagus Nerve Stimulation (VNS) is as effective in treating depression in clinical practice as was shown in clinical trials. VNS is a treatment where short bursts of electric activity are administered to targeted loci in the brain via the vagus nerve. A pulse generator is implanted under the skin near the chest and leads are threaded to the vagus nerve. VNS was approved for epilepsy in 1997 and for treatment-resistant depression in 2005. Though approved for depression, VNS is used for the most part as a last ditch option for medically refractory epilepsy. Increasing recognition, clinical data, and established reimbursement paradigms have allowed VNS to be used more widely for epilepsy than for depression.
In this new study, published in the Journal of Clinical Psychiatry by Cristancho and colleagues, VNS was implanted in 15 patients with treatment-resistant depression (10 had Major Depressive Disorder and 5 had Bipolar Disorder). Though the study was relatively small and performed on a limited number of people, the findings do show that VNS is a feasible and effective treatment for depressed patients who do not respond positively to medication management. Using the Beck Depression Inventory, the mean scores fell from 37.8 to 24.6 from using VNS for 12 months, with one case of remission. When using the Hamilton Depression Rating Scale instead of the Beck Depression Inventory as an outcome measure, six patients (43 percent) responded well to VNS and two patients went into remission at 12 months.
Studies such as these demonstrate that VNS is a viable treatment option for depression. Additional studies, with larger sample sizes and increased follow-up times, will add to the repertoire of clinical data justifying VNS for depression and likely enhance uptake. While clinical trials and practical outcomes may increase acceptance of VNS for depression, insurance coverage and reimbursement decisions will ultimately influence use. Since VNS is a surgical procedure with device costs of approximately $20K, most patients will only undergo treatment if covered by insurance. Currently, restrictive reimbursement from Medicare and commercial payers has hindered VNS use. The University of Pennsylvania study researchers noted that most patients were denied VNS coverage until a detailed clinical justification for VNS use was submitted by the provider.

http://www.advisory.com/Research/Technology-Insights/The-Pipeline/2011/02/New-Data-Suggests-VNS-Effective-in-Managing-Depression-in-Everyday-Practice

Neurosurgery. 2010 Dec;67(2 Suppl Operative):457-60.

Revision of vagal nerve stimulator electrodes through a posterior cervical triangle approach: technical note.

O'Neill BR, Wilberger JE.

Source

Division of Pediatric Neurosurgery, The Children's Hospital, University of Colorado, Aurora, Colorado, USA. Boneill35@gmail.com

Abstract

BACKGROUND:

We describe an approach to vagal nerve stimulator (VNS) lead replacement through the posterior cervical triangle. Scar around the structures of the carotid sheath is avoided and new leads are placed on a pristine section of the vagus nerve proximal to the original site.

CLINICAL PRESENTATION:

Skin incision from the implantation surgery is incorporated and extended to allow access to the posterior border of the sternocleidomastoid muscle (SCM). Dissection proceeds along the posterior border of the SCM. The SCM and jugular vein are retracted anterior to expose a fresh segment of the vagal nerve immediately superficial to the carotid artery and proximal to the original electrode site. Once the nerve is adequately exposed, electrode placement proceeds in the standard fashion. Dysfunctional electrodes are left in place, and the lead wire is cut as near the electrodes as can be easily accessed. Three patients have undergone lead revision with this approach. Lead placement was successful and free from complications in all cases.

CONCLUSION:

The posterior cervical triangle approach provides a virgin dissection plane for VNS revision.

PMID:

21099572

[PubMed - indexed for MEDLINE]

http://www.ncbi.nlm.nih.gov/pubmed/21099572