VNS Therapy™ provides a unique, favorable
safety and tolerability profile. Most acute side effects occur only
during stimulation.1 These effects are typically mild
to moderate and may diminish over time. Tolerability may be improved
by the adjustment of parameter settings during office visits.2
The VNS Therapy System cannot be used in patients
after a bilateral or left cervical vagotomy. VNS Therapy is contraindicated
for use with shortwave diathermy, microwave diathermy or therapeutic
ultrasound diathermy as the potential may exist for the energy delivered
by diathermy to cause heating of the VNS Therapy System. Additionally,
if an MRI should be required for a patient implanted with VNS Therapy,
use only a transmit and receive head coil. The heat induced in the
Lead by a full body coil MRI has the potential to cause injury.3
Regarding teratogenicity with VNS Therapy, there are no adequate
and well-controlled studies of VNS in pregnant women. Reproduction
studies have been performed using female rabbits stimulated with
the commercially available VNS Therapy System at stimulation dose
settings similar to those used for humans. These animal studies
have revealed no evidence of impaired fertility or harm to the fetus
due to VNS therapy. Because animal reproduction studies are not
always predictive of human response and animal studies cannot address
developmental abnormalities, VNS should be used during pregnancy
only if clearly needed. Although the operating ranges of the VNS
Therapy System and fetal monitors are dissimilar and no interaction
would be expected, testing has not been performed. Therefore, the
potential may exist for interaction between the VNS Therapy System
and fetal monitoring systems.
For additional information, please link either
to the brief
summary or the Physician’s
Manual for the VNS Therapy Pulse Model 102 Generator.
References:
*3-month results (high stimulation only, n=152). Physician’s
Manual, VNS Therapy Pulse Model 102 Generator, Cyberonics, Inc.;
June 2002.
†Year 1, 2, and 3 results (all study patients, n=440). Morris
GL III, Mueller WM. Neurology. 1999;53:1731-1735.
1Boon P, et al. Acta
Neurol Belg. 1999;99:275-280.
2Schachter SC, Saper CB. Epilepsia. 1998;39:677-686.
3Physician’s Manual, VNS Therapy Pulse Model 102
Generator, Cyberonics, Inc.; June 2002
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