Cyberonics Announces 100,000th Patient Implant of VNS Therapy®

Announcement highlights important patient milestone during 25th anniversary year

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HOUSTON, Dec. 20, 2012 /PRNewswire/ -- Cyberonics, Inc. (NASDAQ: CYBX) today announced the 100,000th patient implant of its Vagus Nerve Stimulation (VNS) Therapy system. The announcement comes as Cyberonics recognizes a milestone year marking the 25th anniversary of the company's founding. The VNS Therapy System for the treatment of epilepsy received CE Mark approval 18 years ago, and this year marks the 15th anniversary of approval by the United States Food and Drug Administration (FDA).

 

According to an Institute of Medicine Report released earlier this year, approximately one in 26 people will develop epilepsy at some point during their lives. VNS Therapy is a unique device-based treatment option specifically developed for people with refractory epilepsy. Epilepsy is considered refractory when seizures are not adequately controlled by medications alone or when the side effects associated with seizure medications are intolerable. Recently-published data from New York University clinician researchers show that more than 60 percent of people with refractory epilepsy treated with adjunctive VNS Therapy experience 50 percent or greater reduction in seizures. Clinician researchers from Emory University have also shown in a recent publication that adding VNS Therapy to the treatment regimen of patients experiencing refractory epilepsy is associated with significant reductions in resource utilization (ER visits, hospitalizations, and inpatient days) and epilepsy‐related clinical events, as well as a net cost savings after 1.5 years.

 

"Cyberonics is proud to acknowledge this important milestone and the impact VNS Therapy has made on the lives of so many people with epilepsy and their families," said Dan Moore , Cyberonics' President and Chief Executive Officer. "We look forward to expanding access to VNS Therapy and innovating new therapeutic options for patients around the world."

 

VNS Therapy device technology has evolved over time to become smaller, have a longer battery life and offer new programming functionalities. The latest model of VNS Therapy, the AspireHC® generator, is available in the U.S. and in Europe. The AspireHC generator offers physicians and patients additional options, such as longer battery life, improved electronics and enhanced programming features. Cyberonics continues to develop new device-based solutions for epilepsy, including the ProGuardian™ system, an innovative, in-home monitoring system; the AspireSR™ generator, a VNS Therapy system featuring automatic magnet-mode stimulation; and Relay™, a wireless-enabled generator.

http://www.prnewswire.com/news-releases/cyberonics-announces-100000th-patient-implant-of-vns-therapy-184314661.html

2012-12-13 VNS Therapy - Joyce's 13th Anniversary

2012-12-13 VNS Therapy - Joyce's 13th Anniversary

Seishin Shinkeigaku Zasshi. 2012;114(10):1208-15.

[Will electroconvulsive therapy disappear in the near future?].

[Article in Japanese]

Motohashi N.

Source

Department of Neuropsychiatry, Interdisciplinary Graduate School of Medicine and Engineering, University of Yamanashi.

Abstract

Electroconvulsive therapy (ECT) has been widely used, with some modification of its methods, for the treatment of refractory mental disorders. In Japan, brief-pulse ECT was approved in 2002 under conditions that well-trained psychiatrists should administer ECT and that modified ECT is mandatory. However, unmodified ECT is still often performed in Japan. We have to improve safety of ECT further. Major indications for ECT are depression and catatonia. Mechanisms of ECT are still unknown, but the neurogenesis hypothesis is promising. Furthermore, several brain stimulation techniques without seizure induction, such as transcranial magnetic stimulation, vagus nerve stimulation, deep brain stimulation and transcranial direct current stimulation, have been introduced for the treatment of refractory mental disorders. Ethical criteria must be determined for further research and treatment with these techniques.

PMID:

23234202

[PubMed - in process]

http://www.ncbi.nlm.nih.gov/pubmed/23234202

press release

Nov. 8, 2012, 7:00 a.m. EST

Pilot Study Extension Indicates Long-Term Treatment Durability with BioControl Medical's CardioFit(R) System

YEHUD, Israel & NEW HOPE, Minn., Nov 08, 2012 (BUSINESS WIRE) -- BioControl Medical has announced that pilot study extension results unveiled at the American Heart Association Scientific Sessions 2012 have indicated durability of treatment with its CardioFit(R) system for heart failure. Presented on November 7 in "Long-term Benefits of Vagal Nerve Stimulation Therapy in Heart Failure," the extended study data showed that the CardioFit's favorable clinical effects - as demonstrated by improved hemodynamics, quality of life and six-minute walk test - were maintained in patients beyond the study's original six- and 12-month evaluation points, up to 24 months.(1)

"These results are an encouraging validation of vagus nerve stimulation's potential as an effective long-term treatment for heart failure," said Dr. Srdjan Raspopovic, Clinical Center of Serbia, Belgrade, Serbia, a CardioFit pilot study investigator who presented the data at AHA 2012. "Larger controlled studies are currently underway to confirm these findings, and if they do, we believe that VNS will become an important new treatment alternative in the heart failure armamentarium."

Conducted in Italy, Germany, The Netherlands and Serbia, the original multi-center pilot clinical study of the CardioFit was designed to assess the six-month safety and clinical response to the therapy in 32 patients with NYHA II-IV heart failure on optimized background medical therapy.

Study data showed that patients experienced sustained significant improvement across key clinical measures at six and 12 months, including left ventricular function and structure, heart rate variability, and resting heart rate.(2) Patients also showed improvement in self-reported quality of life surveys and six-minute hall walk tests.(2) The study extension's 24-month data, available on 19 patients, showed sustained clinical improvement with the CardioFit therapy. Patient follow up now extends beyond four years, with good therapy tolerance and no reported safety issues.

"The extended pilot results are important data that build on BioControl Medical's growing body of research supporting VNS for the treatment of heart failure," said Ehud Cohen, Ph.D., chief executive officer of BioControl Medical. "We thank the investigators for their rigorous work assessing the long-term effects of CardioFit in our early study, and we look forward to gathering more data on a broader population of patients as our pivotal clinical trial continues to advance."

The safety and efficacy of the CardioFit is being explored further in the INOVATE-HF (INcrease Of VAgal TonE in Heart Failure) global, multi-center, investigational device exemption (IDE) clinical study. Initiated in April 2011, INOVATE-HF is a prospective, randomized, controlled clinical study that will evaluate the system's potential to reduce hospitalization and death among patients with HF, while also exploring whether combined treatment with CardioFit and prescription drug therapy is more effective than drug therapy alone.(3)

INOVATE-HF will ultimately enroll up to 650 patients at up to 80 centers in the United States and Europe. Results of the INOVATE-HF study will be used to support a Premarket Approval Application (PMA) to the U.S. Food and Drug Administration (FDA) for market clearance of CardioFit.

About the CardioFit

The CardioFit system consists of a stimulator, a sensor lead and a stimulation lead, which are implanted under the skin of the chest. The sensor lead is extended from the stimulator to the right ventricle of the heart, and the stimulation lead is extended from the stimulator to the vagus nerve on the right side of the neck. Once activated, the stimulator's electrical pulses are transferred via the stimulation lead to the vagus nerve. At the same time, the sensor lead monitors changes in heart activity and turns stimulation on or off accordingly. Like a pacemaker, the CardioFit System can be programmed on and off via external wireless communication with the device.

About BioControl Medical

Headquartered in Yehud, Israel with offices in New Hope, Minn., BioControl Medical develops and markets advanced implantable devices for the treatment of autonomic disorders, conditions whereby the autonomic nervous system ceases to function properly, resulting in a disruption to the control of involuntary body processes. The devices enable controlled electrical stimulation of various nerves to achieve therapeutic results. For more information on BioControl Medical, visit www.biocontrol-medical.com .

Caution: In the United States, the CardioFit is an investigational device. Limited by Federal (or United States) law to investigational use.

References
(1)Dennert R, et al. "Long-term Benefits of Vagal Nerve Stimulation Therapy in Heart Failure." American Heart Association Scientific Sessions 2012.
(2)De Ferrari GM, Crijns HJ, Borggrefe M, Milasinovic G, Smid J, Zabel M, Gavazzi A, Sanzo A, Dennert R, Kuschyk J, Raspopovic S, Klein H, Swedberg K, Schwartz PJ. "Chronic vagus nerve stimulation: a new and promising therapeutic approach for chronic heart failure." Eur Heart J (2011) 32 (7): 847-855.
(3)Hauptman PJ, Schwartz PJ, Gold MR, Borggrefe M, Van Veldhuisen DJ, Starling, RC, Mann DL. "Rationale and study design of the INcrease Of Vagal TonE in Heart Failure study: INOVATE-HF." American Heart Journal (June 2012) 163 (6): 955-962.
SOURCE: BioControl Medical

http://www.marketwatch.com/story/pilot-study-extension-indicates-long-term-treatment-durability-with-biocontrol-medicals-cardiofitr-system-2012-11-08

J Neural Transm. 2012 Nov 2. [Epub ahead of print]

Auricular transcutaneous electrical nerve stimulation in depressed patients: a randomized controlled pilot study.

Hein E, Nowak M, Kiess O, Biermann T, Bayerlein K, Kornhuber J, Kraus T.

Source

Frankenalb-Klinik Engelthal, Clinic for Psychiatry, Psychotherapy, Psychosomatic Medicine, and Addiction Rehabilitation, Reschenbergstraße 20, 91238, Engelthal, Germany, ernst.hein@yahoo.de.

Abstract

Invasive vagus nerve stimulation has been demonstrated to be an effective treatment in major depressive episodes. Recently, a novel non-invasive method of stimulating the vagus nerve on the outer canal of the ear has been proposed. In healthy subjects, a prominent fMRI BOLD signal deactivation in the limbic system was found. The present pilot study investigates the effects of this novel technique of auricular transcutaneous electric nerve stimulation in depressed patients for the first time. A total of 37 patients suffering from major depression were included in two randomized sham controlled add-on studies. Patients were stimulated five times a week on a daily basis for the duration of 2 weeks. On days 0 and 14, the Hamilton Depression Rating Scale (HAMD) and the Beck Depression Inventory (BDI) were assessed. In contrast to sham-treated patients, electrically stimulated persons showed a significantly better outcome in the BDI. Mean decrease in the active treatment group was 12.6 (SD 6.0) points compared to 4.4 (SD 9.9) points in the sham group. HAMD score did not change significantly in the two groups. An antidepressant effect of a new transcutaneous auricular nerve stimulation technique has been shown for the first time in this controlled pilot study. Regarding the limitations of psychometric testing, the risk of unblinding for technical reasons, and the small sample size, further studies are necessary to confirm the present results and verify the practicability of tVNS in clinical fields.

PMID:

23117749

[PubMed - as supplied by publisher]

http://www.ncbi.nlm.nih.gov/pubmed/23117749

Related citations in PubMed

• BOLD fMRI deactivation of limbic and temporal brain structures and mood enhancing effect by transcutaneous vagus nerve stimulation.[J Neural Transm. 2007]
  BOLD fMRI deactivation of limbic and temporal brain structures and mood enhancing effect by transcutaneous vagus nerve stimulation.

  Kraus T, Hösl K, Kiess O, Schanze A, Kornhuber J, Forster C. J Neural Transm. 2007; 114(11):1485-93. Epub 2007 Jun 14.
• Repetitive transcranial magnetic stimulation for the treatment of major depressive disorder: an evidence-based analysis.[Ont Health Technol Assess Ser....]
  Repetitive transcranial magnetic stimulation for the treatment of major depressive disorder: an evidence-based analysis.

  Health Quality Ontario. Ont Health Technol Assess Ser. 2004; 4(7):1-98. Epub 2004 Jun 1.
• Sensitivity to detect change and the correlation of clinical factors with the Hamilton Depression Rating Scale and the Beck Depression Inventory in depressed inpatients.[Psychiatry Res. 2012]
  Sensitivity to detect change and the correlation of clinical factors with the Hamilton Depression Rating Scale and the Beck Depression Inventory in depressed inpatients.

  Schneibel R, Brakemeier EL, Wilbertz G, Dykierek P, Zobel I, Schramm E. Psychiatry Res. 2012 Jun 30; 198(1):62-7. Epub 2012 Mar 22.
• Review Transcutaneous electrical nerve stimulation (TENS) for dementia.[Cochrane Database Syst Rev. 2003]
  Review Transcutaneous electrical nerve stimulation (TENS) for dementia.

  Cameron M, Lonergan E, Lee H. Cochrane Database Syst Rev. 2003; (3):CD004032.
• Review Effects of auricular acupuncture-like transcutaneous electric nerve stimulation on pain levels following wound care in patients with burns: a pilot study.[J Burn Care Rehabil. 1990]
  Review Effects of auricular acupuncture-like transcutaneous electric nerve stimulation on pain levels following wound care in patients with burns: a pilot study.

  Lewis SM, Clelland JA, Knowles CJ, Jackson JR, Dimick AR. J Burn Care Rehabil. 1990 Jul-Aug; 11(4):322-9.

See reviews...See all...

Epilepsy Curr. 2012 Sep;12(5):188-91. doi: 10.5698/1535-7511-12.5.188.

Neurostimulation-past, present, and beyond.

Ben-Menachem E.

Source

Institution of Clinical Neuroscience and Physiology, Sahlgrenska Academy, Göteborgs University, 413 45 Göteborg, Sweden, ebm@neuor.gu.se.

Abstract

Neurostimulation as a treatment for epilepsy has been around for almost 20 years in the form of vagus nerve stimulation. Newer types of neurostimulation are being developed and stand on the brink of approval for use. The two newest therapies, not yet approved in the United States, are deep brain stimulation and the Responsive Neurostimulator System . In fact, in Europe, approval has already been given for deep brain stimulation and newer forms of vagus nerve stimulation. Efficacy is similar between these therapies, and side effects are moderate, so what will be the future? The challenge will be to learn how to use these therapies correctly and offer the right treatment for the right patient.

PMID:

23118604

[PubMed - in process]

http://www.ncbi.nlm.nih.gov/pubmed/23118604

Related citations in PubMed

• Review Neurostimulation: vagus nerve stimulation and beyond.[Semin Pediatr Neurol. 2011]
  Review Neurostimulation: vagus nerve stimulation and beyond.

  Kotagal P. Semin Pediatr Neurol. 2011 Sep; 18(3):186-94.
• Neurostimulation for epilepsy.[Handb Clin Neurol. 2012]
  Neurostimulation for epilepsy.

  Vonck K, Herdt Vd, Sprengers M, Ben-Menachem E. Handb Clin Neurol. 2012; 108:955-70.
• [Newer treatment of epilepsy--brain pacemakers and transcranial magnetic stimulation].[Rinsho Shinkeigaku. 2005]
  [Newer treatment of epilepsy--brain pacemakers and transcranial magnetic stimulation].

  Akamatsu N. Rinsho Shinkeigaku. 2005 Nov; 45(11):928-30.
• Review Neurostimulation therapies for treatment resistant depression: a focus on vagus nerve stimulation and deep brain stimulation.[Int Rev Psychiatry. 2011]
  Review Neurostimulation therapies for treatment resistant depression: a focus on vagus nerve stimulation and deep brain stimulation.

  Rizvi SJ, Donovan M, Giacobbe P, Placenza F, Rotzinger S, Kennedy SH. Int Rev Psychiatry. 2011 Oct; 23(5):424-36.
• Neurostimulation for the Treatment of Epilepsy: A Review of Current Surgical Interventions.[Neuromodulation. 2012]
  Neurostimulation for the Treatment of Epilepsy: A Review of Current Surgical Interventions.

  Wu C, Sharan AD. Neuromodulation. 2012 Sep 4; . Epub 2012 Sep 4.

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Br J Neurosurg. 2012 Nov 1. [Epub ahead of print]

Long-term effectiveness and tolerability of vagal nerve stimulation in adults with intractable epilepsy: a retrospective analysis of 100 patients.

Ching J, Khan S, White P, Reed J, Ramnarine D, Sieradzan K, Sandeman D.

Source

Department of Neurosurgery, Institute of Neurosciences, Frenchay Hospital , Bristol , UK.

Abstract

Data for 100 vagal nerve stimulation (VNS) patients were collected and analysed retrospectively. The mean seizure reduction was 17.86% (n = 67) at 6 months, 26.21% (n = 63) at 1 year, 30.43% (n = 53) at 2 years, 48.10% (n = 40) at 3 years, 49.44% (n = 32) at 4 years, 50.52% (n = 35) at 5 years, 45.85% (n = 31) at 6 years, 62.68% (n = 25) at 8 years, 76.41% (n = 9) at 10 years, 82.90% (n = 4) at 12 years. Evidence of statistical significance for mean seizure reduction over time was strong with all p values less than 0.05 except at 12 years (p = 0.125) where the sample size was small (n = 4). Mean seizure reduction was 49.04% and 51 (51%) patients were considered responders, defined as a 50% or more reduction in seizure frequency. Twenty-one (21%) patients suffered surgical complications. Of these 15 patients were self-limiting and 6 patients were irreversible or required a device revision. Fifty patients (50%) suffered from side-effects, while vagal stimulation cycled on (VNS on) post-operatively. However, of these, only one patient suffered from intolerable side effects requiring the device to be switched off temporarily. This study demonstrates the long-term efficacy in seizure reduction with the use of VNS. Complication rates and tolerability did not deviate greatly from that previously reported, indicating that VNS is a safe and effective treatment for seizure reduction in intractable epilepsy.

PMID:

23113878

[PubMed - as supplied by publisher]

http://www.ncbi.nlm.nih.gov/pubmed/23113878