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2. INTENDED USE/INDICATIONS
The NCP System is indicated for use as an adjunctive therapy in reducing the
frequency of seizures in adults and adolescents over 12 years of age with partial
onset seizures which are refractory to antiepileptic medications.

3. CONTRAINDICATIONS
The NCP System cannot be used in patients after a bilateral
or left cervical vagotomy.

! CONTRAINDICATION: Do not use shortwave diathermy, microwave
diathermy or therapeutic ultrasound diathermy (hereafter referred to as
diathermy) on patients implanted with a VNS Therapy System. Diagnostic
ultrasound is not included in this contraindication.

Energy delivered by diathermy may be concentrated into or reflected by
implanted products such as the VNS Therapy System. This concentration or
reflection of energy may cause heating.

Testing indicates that diathermy can cause heating of the VNS Therapy
System well above temperatures required for tissue destruction. The heating
of the VNS Therapy System resulting from diathermy can cause temporary or
permanent nerve or tissue or vascular damage. This damage may result in pain
or discomfort, loss of vocal cord function, or even possibly death if there is
damage to blood vessels.

Because diathermy can concentrate or reflect its energy off any sizeimplanted
object, the hazard of heating is possible when any portion of the
VNS Therapy System remains implanted, including just a small portion of the
Lead or electrode. Injury or damage can occur during diathermy treatment
whether the VNS Therapy System is turned ¡°on¡± or ¡°off¡±.

Diathermy is further prohibited because it may also damage the VNS Therapy
System components resulting in loss of therapy, requiring additional surgery
for system explantation and replacement. All risks associated with surgery or
loss of therapy (loss of seizure control) would then be applicable.
Advise your patients to inform all their health care professionals that they
should not be exposed to diathermy treatment.

4. WARNINGS
Physicians should inform patients about all potential risks and adverse events
discussed in the NCP System physician¡¯s manuals.

! The safety and efficacy of the NCP System has not been established for uses
not covered in the ¡°Intended Use/ Indications¡± section of this manual.
! The safety and efficacy of the NCP System treatment have not been
established for stimulation of the right vagus nerve or of any other nerve,
muscle, or tissue.

! Excessive stimulation at a combination of high frequency (¡Ý 50 Hz) and an
excess duty cycle (that is, one that occurs when ON time is greater than OFF
time) has resulted in degenerative nerve damage in laboratory animals. An
excess duty cycle can be produced by continuous or frequent magnet
activation (> 8 hours), as determined by animal studies. Cyberonics
recommends against stimulation at these combinations of ranges.

! Aspiration may result from the increased swallowing difficulties reported by
some patients during stimulation. Patients who have pre-existing swallowing
difficulties are at greater risk for aspiration.

! Device malfunction could cause painful stimulation or direct current
stimulation. Either event could cause nerve damage and other associated
problems. Patients should be instructed to use the magnet to stop stimulation
if they suspect a malfunction, and then to contact their physician immediately
for further evaluation. Prompt surgical intervention may be required if a
malfunction occurs.

! Susceptible patients with predisposed cardiac conduction systems (re-entry
pathway) have not been studied as part of controlled clinical trials to establish
the safety of NCP system treatment in these patients. Evaluation by a
cardiologist is recommended if the family history, patient history, or
electrocardiogram suggests an abnormal cardiac conduction pathway. Serum
electrolytes, magnesium, and calcium should be documented before
implantation. Post-implant electrocardiograms and Holter monitoring are
recommended if clinically indicated.

! Sudden unexplained death in epilepsy (SUDEP): Through August
1996, 10 sudden and unexplained deaths (definite, probable, and
possible) were recorded among the 1,000 patients implanted and treated
with the NCP device. During this period, these patients had accumulated
2,017 patient-years of exposure.

Some of these deaths could represent seizure-related deaths in which the
seizure was not observed, at night, for example. This number represents an
incidence of 5.0 definite, probable, and possible SUDEP deaths per 1,000
patient-years. Although this rate exceeds that expected in a healthy (nonepileptic) population matched for age and sex, it is within the range of
estimates for epilepsy patients not receiving vagus nerve stimulation, ranging
from 1.3 SUDEP deaths for the general population of patients with epilepsy,
to 3.5 (for definite and probable) for a recently studied antiepileptic drug
(AED) clinical trial population similar to the NCP System clinical cohort, to
9.3 for patients with partial onset epilepsy.

! The NCP device is not curative: Physicians should warn patients that the
NCP System is not a cure for epilepsy and that since seizures may occur
unexpectedly, patients should consult with a physician before engaging in
un-supervised activities, such as driving, swimming, and bathing, and in
strenuous sports that could harm them or others.

! Patients with obstructive sleep apnea (OSA) may have increased apneic
events during stimulation. Cyberonics recommends care when treating
patients with preexisting OSA. Lowering stimulus frequency or
prolonging OFF time may prevent exacerbation of OSA.

5. PRECAUTIONS
Physicians should inform patients about all potential risks and adverse events
discussed in the NCP System physician¡¯s manuals.

! Laryngeal irritation may result from stimulation. Patients who smoke may
have an increased risk of laryngeal irritation.

! Dyspnea may result from stimulation. Patients with chronic obstructive
pulmonary disease may have an increased risk of dyspnea.

! It is important to follow recommended implantation procedures and
intraoperative product testing described in this manual. During the
intraoperative Lead Test, infrequent incidents of bradycardia and/or asystole
have occurred. If asystole, severe bradycardia (heart rate < 40 bpm), or a
clinically significant change in heart rate is encountered during a Lead Test or
during initiation of stimulation, physicians should be prepared to follow
guidelines consistent with Advanced Cardiac Life Support (ACLS).

Additionally, postoperative bradycardia can occur among patients with certain
underlying cardiac arrhythmias. If a patient has experienced asystole, severe
bradycardia (heart rate < 40 bpm) or a clinically significant change in heart
rate during a Lead Test at the time of initial device implantation, the patient
should be placed on a cardiac monitor during initiation of stimulation.

The safety of this therapy has not been systematically established for patients
experiencing bradycardia or asystole during VNS Therapy System
implantation.

! Reversal of lead polarity has been associated with an increased chance of
bradycardia in animal studies. It is important to make sure that the Lead
connector pins are correctly inserted (white marker to + connection) into the
Pulse Generator header.

! Do not program the NCP System to an ON or periodic stimulation
treatment for at least 14 days after the initial or replacement
implantation. Failure to observe this precaution may result in patient
discomfort or adverse events.

! Resetting the Pulse Generator turns the device OFF (output current = 0
mA), and all device history information is lost. The device history information
should be printed out before resetting.

! It is important to follow infection control procedures. Infections related to
any implanted device are difficult to treat and may require that the device be
explanted. Cyberonics recommends that the patient be given antibiotics
preoperatively. The surgeon should ensure that all instruments, including the
NCP Tunneling Tool, are sterile prior to the operation.

Cyberonics recommends frequent irrigation of both incision sites with
generous amounts of bacitracin or equivalent solution prior to closure. (These incisions should be closed with cosmetic closure techniques to minimize
scarring.) Also, antibiotics should be administered postoperatively at the
discretion of the physician.

! The NCP System is indicated for use only in stimulating the left vagus nerve
in the neck area inside the carotid sheath.

! The NCP System is indicated for use only in stimulating the left vagus nerve
below where the superior and inferior cervical cardiac branches separate
from the vagus nerve.

! Implanting physicians should be experienced operating in the carotid sheath;
they should be familiar with vagal anatomy, particularly the cardiac branches;
and they should be trained for the surgical implantation of the NCP System.
See the section ¡°Physician Training/Information¡± in this manual.

! A neck brace can be used by the patient for the first week to help ensure
proper Bipolar Lead stabilization.

! Appropriate physician training is very important:

♦ Prescribing physicians should be experienced in the diagnosis and
treatment of epilepsy and should be familiar with the programming and
use of the NCP System.
♦ Implanting physicians should be experienced operating in the carotid
sheath and should be trained for surgical implantation of the NCP System.
(See the ¡°Physician Training/Information¡± section of this manual for more
information.)

MANUALS