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Enabling your patients to enjoy life
Just like everyone else, patients with difficult-to-treat epilepsy want to enjoy their lives. However, it
is inevitably difficult to provide help to patients who have tried out a number of different epilepsy
EUROPEAN INDICATION FOR USE:
treatments with little or no success.
The VNS Therapy System is indicated for use as an
adjunctive therapy in reducing the frequency of seizures in
patients whose epileptic disorder is dominated by partial
VNS Therapy has been developed for both adults and children and is applied through a small device.This
seizures (with or without secondary generalisation) or
non-pharmacological treatment is an adjunctive therapy to be used with drugs, and this means that your
generalised seizures, which are refractory to antiepileptic
patients’ medication intake might be reduced. In turn, this could lead to a reduction in the side effects
medications.
associated with the drugs they are taking.
Cyberonics Europe S.A./N.V.
Belgicastraat 9, 1930 Zaventem, Belgium
Tel. +32 2 720 95 93, Fax +32 2 720 60 53
VNS Therapy could help your patients to experience reductions in the frequency and intensity of their
www.VNSTherapy.eu seizures. Furthermore, your patients may feel improvements in terms of their mood, alertness and sense
© 2007 Cyberonics, Inc.All rights reserved.
of control.
Cyberonics
®
is a registered trademark of Cyberonics, Inc.
VNS Therapy
TM
is a trademark of Cyberonics, Inc. In essence, the aim of VNS Therapy is to help your patients to experience increased confidence,
REFERENCES: Morris G.L. et al. independence and enjoyment of life.Neurology 1999; 53(7):1731-1735 • Tatum W.O.
et al. Neurology 2001; 56(4):561-563 • Harden C.L. et al. Epilepsy & Behavior
2000; 1:93-99 • Elger G. et al. Epilepsy Research 2000; 42:203-210 • VNS Therapy
Patients Registry,April 25, 2003. Data on file, Cyberonics, Inc. Houston,Tex. • The reality is that there are a limited number of options in dealing with difficult-to-treat
Rychlicki F. et al. Seizure 2006; 15(7):483-490 • Matsuura M. Psychiatry and Clinical
epilepsy. By choosing VNS Therapy, you might well find the option that will best suit your
Neurosciences 2000; 54(2):249-253 • Henry T. R. Neurology 2002; 59(Suppl 4):
S3-S14 • Fromes G.A. et al. Epilepsia 2000; 41(7):117 patients.
Brief Summary
1
of Safety Information for the VNS Therapy™ System [Epilepsy and epilepsy patients not receiving vagus nerve stimulation, ranging from 1.3 SUDEP deaths for the Lead by an MRI body scan can cause injury. Additionally, in vitro tests have shown that
Depression Indications] (March 2007) the general population of patients with epilepsy, to 3.5 (for definite and probable) for a an intact Lead without an implanted Pulse Generator presents substantially the same
1. INTENDED USE / INDICATIONS Epilepsy (Non-US) — The VNS Therapy System is recently studied antiepileptic drug (AED) clinical trial population similar to the VNS Therapy hazards as a full VNS Therapy System. If an MRI should be done, use only a transmit-and-
indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients System clinical cohort, to 9.3 for patients with medically intractable epilepsy who were receive type of head coil. MRI compatibility was demonstrated using 1.5T General Electric
whose epileptic disorder is dominated by partial seizures (with or without secondary epilepsy surgery candidates. 5. WARNINGS — DEPRESSION This device is a permanent Signa and 3.0T Philips MR systems. Use caution when other MR systems are used, since
generalization) or generalized seizures that are refractory to antiepileptic medications. implant. It is only to be used in patients with severe depression who are unresponsive to adverse events may occur because of different magnetic field distributions. Consider other
Depression (Non-US) — The VNS Therapy System is indicated for the treatment of chronic standard psychiatric management. It should only be prescribed and monitored by physicians imaging modalities when appropriate. Procedures in which the radio frequency (RF) is
or recurrent depression in patients that are in a treatment-resistant or treatment-intolerant who have specific training and expertise in the management of treatment-resistant transmitted by the body coil should not be done on a patient who has the VNS Therapy
depressive episode. 2. CONTRAINDICATIONS Vagotomy — The VNS Therapy System depression and the use of this device. It should only be implanted by physicians who are System.Thus, protocols must not be used that utilize local coils that are RF receive-only, with
cannot be used in patients after a bilateral or left cervical vagotomy. Diathermy — Do not trained in surgery of the carotid sheath and have received specific training in the implantation RF-transmit performed by the body coil. Note that some RF head coils are receive-only, and
use short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy on of this device. Physicians should warn patients that VNS Therapy has not been determined that most other local coils, such as knee and spinal coils, are also RF-receive only.These coils
patients implanted with a VNS Therapy System. Diagnostic ultrasound is not included in this to be a cure for depression. Patients being treated with adjunctive VNS Therapy should be must not be used in patients with the VNS Therapy System. See MRI with the VNS Therapy
contraindication. 3. WARNINGS — GENERAL Physicians should inform patients about all observed closely for clinical worsening and suicidality, especially at the time of VNS Therapy System (Non-U.S. version) for details. Extracorporeal shockwave lithotripsy may damage
potential risks and adverse events discussed in the physician’s manuals.This document is not stimulation parameter changes or drug or drug dose changes. Excessive stimulation: Note: the Pulse Generator. If therapeutic ultrasound therapy is required, avoid positioning the area
intended to serve as a substitute for the complete physician’s manuals. The safety and Use of the Magnet to activate stimulation is not recommended for patients with depression. of the body where the Pulse Generator is implanted in the water bath or in any other
efficacy of the VNS Therapy System have not been established for uses outside the “Intended 6. PRECAUTIONS — GENERAL Physicians should inform patients about all potential risks position that would expose it to ultrasound therapy. If that positioning cannot be avoided,
Use/Indications” section of the physician’s manuals.The safety and effectiveness of the VNS and adverse events discussed in the VNS Therapy physician’s manuals. Prescribing physicians program the Pulse Generator output to 0 mA for the treatment, and then after therapy,
Therapy System in patients with predisposed dysfunction of cardiac conduction systems should be experienced in the diagnosis and treatment of depression or epilepsy and should reprogram the Pulse Generator to the original parameters. If the patient receives medical
(re-entry pathway) have not been established. Post-implant electrocardiograms and Holter be familiar with the programming and use of the VNS Therapy System. Physicians who treatment for which electric current is passed through the body (such as from a TENS unit),
monitoring are recommended if clinically indicated. Postoperative bradycardia can occur implant the VNS Therapy System should be experienced performing surgery in the carotid either the Pulse Generator should be set to 0 mA or function of the Pulse Generator
among patients with certain underlying cardiac arrhythmias. It is important to follow sheath and should be trained in the surgical technique relating to implantation of the VNS should be monitored during initial stages of treatment. Routine therapeutic ultrasound
recommended implantation procedures and intraoperative product testing described in the Therapy System. The safety and effectiveness of the VNS Therapy System have not been could damage the Pulse Generator and may be inadvertently concentrated by the device,
Implantation Procedure part of the physician’s manuals. During the intraoperative System established for use during pregnancy.VNS should be used during pregnancy only if clearly causing harm to the patient. For complete information related to home occupational
Diagnostics (Lead Test), infrequent incidents of bradycardia and/or asystole have occurred. If needed.The VNS Therapy System is indicated for use only in stimulating the left vagus nerve environments, cellular phones, other environmental hazards, other devices, and ECG
asystole, severe bradycardia (heart rate <40 bpm), or a clinically significant change in heart in the neck area inside the carotid sheath.The VNS Therapy System is indicated for use only monitors, refer to the physician’s manuals. 8. ADVERSE EVENTS — EPILEPSY Adverse
rate is encountered during a System Diagnostics (Lead Test) or during initiation of in stimulating the left vagus nerve below where the superior and inferior cervical cardiac events reported during clinical studies as statistically significant are listed below in
stimulation, physicians should be prepared to follow guidelines consistent with Advanced branches separate from the vagus nerve. It is important to follow infection control alphabetical order: ataxia (loss of the ability to coordinate muscular movement); dyspepsia
Cardiac Life Support (ACLS). Difficulty swallowing (dysphagia) may occur with active procedures. Infections related to any implanted device are difficult to treat and may require (indigestion); dyspnea (difficulty breathing, shortness of breath); hypesthesia (impaired sense
stimulation, and aspiration may result from the increased swallowing difficulties. Patients with that the device be explanted. The patient should be given antibiotics preoperatively. The of touch); increased coughing; infection; insomnia (inability to sleep); laryngismus (throat,
pre-existing swallowing difficulties are at greater risk for aspiration. Dyspnea (shortness of surgeon should ensure that all instruments are sterile prior to the procedure. The VNS larynx spasms); nausea; pain; paresthesia (prickling of the skin); pharyngitis (inflammation of
breath) may occur with active VNS Therapy.Any patient with underlying pulmonary disease Therapy System may affect the operation of other implanted devices, such as cardiac the pharynx, throat); voice alteration (hoarseness); vomiting. 9. ADVERSE EVENTS —
or insufficiency such as chronic obstructive pulmonary disease or asthma may be at pacemakers and implanted defibrillators. Possible effects include sensing problems and DEPRESSION Implant-related adverse events reported during the pivotal study in ≥ 5% of
increased risk for dyspnea. Patients with obstructive sleep apnea (OSA) may have an inappropriate device responses. If the patient requires concurrent implantable pacemaker, patients are listed in order of decreasing occurrence: incision pain, voice alteration, incision
increase in apneic events during stimulation. Lowering stimulus frequency or prolonging defibrillatory therapy or other types of stimulators, careful programming of each system may site reaction, device site pain, device site reaction, pharyngitis, dysphagia, hypesthesia,
“OFF” time may prevent exacerbation of OSA.Vagus nerve stimulation may also cause new be necessary to optimize the patient’s benefit from each device. Reversal of Lead polarity dyspnea, nausea, headache, neck pain, pain, paresthesia, and cough increased. Stimulation-
onset sleep apnea in patients who have not previously been diagnosed with this disorder. has been associated with an increased chance of bradycardia in animal studies.It is important related adverse events reported during the acute sham-controlled study by ≥ 5% of VNS
Device malfunction could cause painful stimulation or direct current stimulation. Either event that the electrodes are attached to the left vagus nerve in the correct orientation. It is also Therapy-treated patients are (in order of decreasing occurrence): voice alteration, cough
could cause nerve damage. Patients should be instructed to use the Magnet to stop important to make sure that Leads with dual connector pins are correctly inserted (white increased, dyspnea, neck pain, dysphagia, laryngismus, paresthesia, pharyngitis, nausea, and
stimulation if they suspect a malfunction, and then to contact their physician immediately for marker band to + connection) into the Pulse Generator’s Lead receptacles.The patient can incision pain.
further evaluation. Patients with the VNS Therapy System or any part of the VNS Therapy use a neck brace for the first week to help ensure proper Lead stabilization. Do not
System implanted should not have full body MRI. Excessive stimulation at an excess duty program the VNS Therapy System to an “ON” or periodic stimulation treatment for at least Cyberonics, Inc., 100 Cyberonics Boulevard, Houston,Texas 77058 USA,
cycle (that is, one that occurs when “ON” time is greater than “OFF” time) has resulted in 14 days after the initial or replacement implantation. Do not use frequencies of 5 Hz or Tel. 281-228-7200 / 800-332-1375, Fax 281-218-9332
degenerative nerve damage in laboratory animals. Patients who manipulate the Pulse below for long-term stimulation. Resetting the Pulse Generator turns the device OFF Cyberonics Europe, S.A./N.V., Belgicastraat 9, 1930 Zaventem, Belgium,
Generator and Lead through the skin (Twiddler’s Syndrome) may damage or disconnect the (output current = 0.0 mA), and all device history information is lost. Patients who smoke Tel. +32 2 720 95 93, Fax +32 2 720 60 53
Lead from the Pulse Generator and/or possibly cause damage to the vagus nerve. 4. may have an increased risk of laryngeal irritation. 7. ENVIRONMENTAL AND MEDICAL www.VNSTherapy.com
WARNINGS — EPILEPSY The VNS Therapy System should only be prescribed and THERAPY HAZARDS Patients should exercise reasonable caution in avoiding devices that
monitored by physicians who have specific training and expertise in the management of generate a strong electric or magnetic field. If a Pulse Generator ceases operation while in 26-0006-8800/2
seizures and the use of this device. It should only be implanted by physicians who are trained the presence of electromagnetic interference (EMI), moving away from the source may © 2006, 2007 Cyberonics, Inc., Houston,TX.All rights reserved. Cyberonics
®
and NCP
®
are
in surgery of the carotid sheath and have received specific training in the implantation of this allow it to return to its normal mode of operation.VNS Therapy System operation should registered trademarks of Cyberonics, Inc. “VNS,” “VNS Therapy,” “Demipulse,” “Demipulse
device.The VNS Therapy System is not curative. Physicians should warn patients that the always be checked by performing device diagnostics after any of the procedures mentioned Duo,” and “Perennia” are trademarks of Cyberonics, Inc.
VNS Therapy System is not a cure for epilepsy and that since seizures may occur in the physician’s manuals. For clear imaging, patients may need to be specially positioned for
unexpectedly, patients should consult with a physician before engaging in unsupervised mammography procedures, because of the location of the Pulse Generator in the chest.
1
The information contained in this Brief Summary for Physicians represents partial excerpts
activities, such as driving, swimming, and bathing, and in strenuous sports that could harm Therapeutic radiation may damage the Pulse Generator’s circuitry, although no testing has of important prescribing information taken from the physician’s manuals. (Copies of VNS
them or others. Sudden unexplained death in epilepsy (SUDEP):Through August 1996, 10 been done to date and no definite information on radiation effects is available. Sources of Therapy physician’s and patient’s manuals are posted at www.VNSTherapy.com/manuals.)
sudden and unexplained deaths (definite, probable, and possible) were recorded among the such radiation include therapeutic radiation, cobalt machines, and linear accelerators. The The information is not intended to serve as a substitute for a complete and thorough
1,000 patients implanted and treated with the VNS Therapy device. During this period, these radiation effect is cumulative, with the total dosage determining the extent of damage.The understanding of the material presented in all of the physician’s manuals for the VNS
patients had accumulated 2,017 patient-years of exposure. Some of these deaths could effects of exposure to such radiation can range from a temporary disturbance to permanent Therapy System and its component parts nor does this information represent full
represent seizure-related deaths in which the seizure was not observed, at night, for damage, and may not be detectable immediately. External defibrillation may damage the disclosure of all pertinent information concerning the use of this product, potential safety
example.This number represents an incidence of 5.0 definite, probable, and possible SUDEP Pulse Generator. Use of electrosurgery [electrocautery or radio frequency (RF) ablation complications, or efficacy outcomes.
deaths per 1,000 patient-years. Although this rate exceeds that expected in a healthy devices] may damage the Pulse Generator. Magnetic resonance imaging (MRI) should not be
ysAdGenA4BS08-11-1000-EC
(nonepileptic) population matched for age and sex, it is within the range of estimates for performed with a magnetic resonance body coil in the transmit mode.The heat induced in Ph
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