The nerve to expect more. The nerve to redefine patient expectations.
The VNS Therapy™ System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients 4 years of age and older with partial onset seizures that are refractory to antiepileptic medications
Children with drug-resistant epilepsy (DRE) who are treated with anti-seizure medications (ASMs) alone could suffer from developmental deterioration that impacts motor and social function1
Pediatric patients who did not achieve seizure freedom for 5 continuous years were at a 5.2× greater risk of SUDEP (95% CI 1.4-18.5)2
SUDEP=sudden unexpected death in epilepsy
Poorly controlled seizures have serious cognitive consequences in the developing brain (N=198, P<0.0001)3
VNS Therapy™ reduces the frequency, duration, and severity of seizures and improves postictal recovery
In a study of 347 pediatric patients followed up for 24 months5:
The nerve to enhance a patient’s quality of life
VNS Therapy™ has shown to offer quality-of-life (QoL) benefits that can help patients overcome the obstacles they face in everyday life.
VNS Therapy™ may be associated with lower SUDEP rates10
Study with 277,661 person-tears of follow up with 2689 deaths, including 632 of SUDEP, showed that long-term VNS Therapy is associated with lower SUDEP rates
The data suggest that SUDEP risk significantly decreases during long-term follow up of patients with refractory epilepsy treated with VNS Therapy. This finding might reflect several factors, including the natural, long-term dynamic of SUDEP rate, attrition, and the impact of VNS Therapy. The role of each of these factors cannot be confirmed due to the limitations of the study.10
SUDEP Rate in years 1-2 of VNS Therapy10
SUDEP Rate in years 3-10 of VNS Therapy10
(rate ratio 0.68; 95% confidence interval [CI] 0.53-0.87; P = 0.002)
VNS Therapy™ has demonstrated safety and is well tolerated
The most common side effects occur during stimulation and typically become less noticeable over time.11,12 The most common side effect of the surgical procedure is infection.13
References: 1. Otsuki T, Kim HD, Luan G, et al. Brain Dev. 2016;38(5):449-460. 2. Sillanpää M, Shinnar S. N Engl J Med. 2010;363(26):2522-2529. 3. Berg, AT, Zelko FA, Levy, SR, et al. Neurology. 2012;79:1384- 1391. 4. Russo A, Hyslop A, Gentile V, et al. J Child Neurol. 2020;883073820974855. doi:10.1177/0883073820974855. 5. Orosz I, McCormick D, Zamponi N, et al. Epilepsia. 2014;55(10):1576-1584. 6. Lo WB, Chevill B, Philip C, et al. Childs Nerv Syst. 2020;10.1007/s00381-020-04962-3. doi:10.1007/s00381-020-04962-3. 7. Englot DJ, Hassnain KH, Rolston JD, et al. Epilepsy Behav. 2017;66:4-9. 8. Soleman J, Stein M, Knorr C, et al. Epilepsy Behav. 2018;88:139-145. 9. Helmers SL, Duh MS, Guerin A, et al. Eur J Paediatr Neurol. 2012;16(5):449-458. 10. Ryvlin P, So EL, Gordon CM, et al. Epilepsia. 2018;59(3):562-572. 11. Ben-Menachem E. J Clin Neurophysiol. 2001;18(5):415 418. 12. Morris GL, Mueller WM. Neurology. 1999;53(7):1731-1735. 13. Epilepsy Patient’s Manual for Vagus Nerve Stimulation, LivaNova, Inc., Houston, TX.