Quality of Life

A stimulating rationale for VNS Therapy^TM - break the cycle of repeated anti-seizure medication (ASM) failures

At least 1/3 of epilepsy patients will not achieve seizure freedom with ASMs^2,3
Patients living with DRE suffer physical, psychological, and societal consequences of refractory seizures along with a heavy drug burden and increased mortality^4-7
Important determinants of health-related quality of life in DRE include the burden of ASM toxicity, depressive symptoms and seizure worry^8,9

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 seizures (with or without secondary generalization) or generalized seizures that are refractory to anti-seizure medications.

VNS Therapy^™ is proven to be a safe adjunctive treatment and is well-tolerated by most patients without contributing to ASM toxicity

Can improve seizure control without contributing to ASM toxicity
No drug interactions—can be combined with any ASM regimen

Most common side effects

The most common side effects of VNS Therapy^™ occur during stimulation and generally become less noticeable over time for most patients^11,12:
- Hoarseness
- Shortness of breath
- Sore throat
- Coughing
Infection is the most common complication of the procedure¹³

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Helps improve your patients' emotional well-being and overall quality of life¹⁴

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Continued reduction in seizure frequency over time: 76% mean seizure frequency reduction in patients that undergo 10 years of VNS Therapy¹⁵

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Associated with reduced depressive symptoms¹⁰

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Proven to be a safe, adjunctive treatment and is well-tolerated by most patients without contributing to ASM toxicity¹³

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Can provide improvements in seizure control with 59% reporting ≥ 50% reduction and 41% reporting ≥ 80% reduction¹⁶

VNS Therapy™ has proven safety and tolerability profile with side effects reducing over time

Safety Profile

VNS Therapy^™ has no drug interactions and does not cause drug-related toxic central nervous system side effects.

Common side effects include hoarseness or change in voice tone, shortness of breath, sore throat, and coughing. Most side effects associated with VNS Therapy occur only during stimulation, tend to diminish over time, or are eliminated by adjusting parameter settings.

The most common side effect of the surgical procedure is infection.

For more safety information click here.

INTENDED USE / INDICATIONS Epilepsy (Non-US) 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 seizures (with or without secondary generalization) or generalized seizures that are refractory to anti-seizure medications.

References

1. Data on file. Survey Report. LivaNova USA, Inc. Houston, TX. October 2021 2. Chen Z, Brodie MJ, Liew D, Kwan P. Treatment Outcomes in Patients With Newly Diagnosed Epilepsy Treated with Established and New Antiepileptic Drugs. JAMA Neurol. 2018;75(3):279-286. 3. Kwan P & Brodie MJ. Early identification of refractory epilepsy. N Engl J Med 2000; 342: 314-9. 4. Wheless JW. Intractable epilepsy: A survey of patients and caregivers. Epilepsy Behav. 2006;8(4):756-764. 5. Gilliam F. Optimizing health outcomes in active epilepsy. Neurology. 2002;58(8 suppl 5):S9-S20. 6. Fisher RS, et al. The impact of epilepsy from the patient's perspective. Epilepsy Res. 2000;41(1):39-51. 7. Thurman DJ, et al. The burden of premature mortality of epilepsy in high-income countries: A systematic review from the Mortality Task Force of the ILAE. Epilepsia. 2017;58(1):17-26. 8. Luoni C, Bisulli F, Canevini MP, et al. Determinants of quality of life in epilepsy. Epilepsia. 2011;52(12):2181-2191. 9. Loring DW, Meador KJ, Lee GP. Determinants of quality of life in epilepsy. Epilepsy Behav. 2004;5(6):976-980. 10. Kim SJ, Kim DY, Jo HJ, et al. Effect of Long-Term Treatment with Vagus Nerve Stimulation on Mood and Quality of Life in Korean Patients with Drug-Resistant Epilepsy. J Clin Neurol. 2021;17(3):385-392. 11. Ben-Menachem E. Vagus Nerve Stimulation, Side Effects, and Long-Term Safety. J Clin Neurophysiol 2001;18(5):415-418. 12. Morris GL, Mueller WM. Long-term treatment with vagus nerve stimulation in patients with refractory epilepsy. Neurology. 1999;53(8):1737-1735. 13. VNS Therapy System Epilepsy Physician's Manual Houston, TX: LivaNova USA Inc.; 2023. 14. Soleman J, Stein M, Knorr C, et al. Improved quality of life and cognition after early vagal nerve stimulator implantation in children. Epilepsy Behav. 2018;88:139-145. 15. Elliott RE, Morsi A, Tanweer O, et al. Efficacy of vagus nerve stimulation over time: Review of 65 consecutive patients with treatment-resistant epilepsy treated with VNS > 10 years. Epilepsy Behav. 2011;20(3):478-483. 16. Hamilton P, Soryal I, Dhahri P, et al. Clinical outcomes of VNS therapy with AspireSR (including cardiac-based seizure detection) at a large complex epilepsy and surgery centre. Seizure. 2018;58:120-126. 17. Data on file. E36 E37 Pooled Calculations. LivaNova USA, Inc. Houston, TX. 2015.

In a survey of 200 VNS Therapy™ patients and caregivers¹:

A stimulating rationale for VNS Therapy^TM - break the cycle of repeated anti-seizure medication (ASM) failures

Stimulating life with VNS Therapy™ - helps improve your patients' emotional well-being and overall quality of life

VNS Therapy^™ is proven to be a safe adjunctive treatment and is well-tolerated by most patients without contributing to ASM toxicity

Most common side effects

VNS Therapy™ can help improve their Qol and reduce the burden of DRE

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VNS Therapy™ has proven safety and tolerability profile with side effects reducing over time

Safety Profile

Choose a country

To see the other countries, please click here.

In a survey of 200 VNS Therapy™ patients and caregivers1:

A stimulating rationale for VNS TherapyTM - break the cycle of repeated anti-seizure medication (ASM) failures

Stimulating life with VNS Therapy™ - helps improve your patients' emotional well-being and overall quality of life

VNS Therapy™ is proven to be a safe adjunctive treatment and is well-tolerated by most patients without contributing to ASM toxicity

Most common side effects

VNS Therapy™ can help improve their Qol and reduce the burden of DRE

-

-

-

-

-

VNS Therapy™ has proven safety and tolerability profile with side effects reducing over time

Safety Profile

Choose a country

To see the other countries, please click here.

In a survey of 200 VNS Therapy™ patients and caregivers¹:

A stimulating rationale for VNS Therapy^TM - break the cycle of repeated anti-seizure medication (ASM) failures

VNS Therapy^™ is proven to be a safe adjunctive treatment and is well-tolerated by most patients without contributing to ASM toxicity