Comparison and Selection of Current Implantable Anti-Epileptic Devices

Wong, S.S.; Mani, Ram S.; Danish, Shabbar F.

doi:10.1007/s13311-019-00727-2

Cited by 38 publications

(41 citation statements)

References 98 publications

(105 reference statements)

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“…The external programming system allows healthcare providers to change generator settings in addition to visualizing and downloading data collected by the device over time (3). A detailed review of the surgical implant procedure, magnetic resonance imaging safety and compatibility, programming principles, and real-world clinical evidence that supports the therapy's use can be found elsewhere (4)(5)(6)(7)(8)(9).…”

Section: Introductionmentioning

confidence: 99%

Evolution of the Vagus Nerve Stimulation (VNS) Therapy System Technology for Drug-Resistant Epilepsy

Afra

Adamolekun

Aydemir

et al. 2021

Front. Med. Technol.

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The vagus nerve stimulation (VNS) Therapy® System is the first FDA-approved medical device therapy for the treatment of drug-resistant epilepsy. Over the past two decades, the technology has evolved through multiple iterations resulting in software-related updates and implantable lead and generator hardware improvements. Healthcare providers today commonly encounter a range of single- and dual-pin generators (models 100, 101, 102, 102R, 103, 104, 105, 106, 1000) and related programming systems (models 250, 3000), all of which have their own subtle, but practical differences. It can therefore be a daunting task to go through the manuals of these implant models for comparison, some of which are not readily available. In this review, we highlight the technological evolution of the VNS Therapy System with respect to device approval milestones and provide a comparison of conventional open-loop vs. the latest closed-loop generator models. Battery longevity projections and an in-depth examination of stimulation mode interactions are also presented to further differentiate amongst generator models.

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Section: Introductionmentioning

confidence: 99%

Evolution of the Vagus Nerve Stimulation (VNS) Therapy System Technology for Drug-Resistant Epilepsy

Afra

Adamolekun

Aydemir

et al. 2021

Front. Med. Technol.

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“…Since 1994 multiple studies have assessed the efficacy and safety of VNS. The largest studies, E03 (multinational) and E05 (US Centers) were of similar design and followed response in patients with refractory epilepsy, which was described as at least 6 focal onset seizures involving loss of awareness in a 30-day period with no more than 21 days in between [56,59,[61][62][63][64]. They were observed for a 3-month baseline period followed by 3 months post-implantation where participants received high (average 1.3 mA) versus low stimulation (average 1.2mA, less stimulation and pulse frequency) [63].…”

Section: Evidencementioning

confidence: 99%

“…It was approved in 1997 for patients >12 years of age and was expanded to include patients >4 years of age as of 2017. VNS consists of stimulating electrodes that are coiled around the left vagus nerve in the carotid sheath and implanted subcutaneously in the left anterior chest wall [18,56,57](See Fig. 3).…”

Section: Introductionmentioning

confidence: 99%

Neuromodulation in Drug Resistant Epilepsy

Rincon¹,

Barr²,

Velez‐Ruiz³

2021

Aging and disease

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Epilepsy affects approximately 70 million people worldwide, and it is a significant contributor to the global burden of neurological disorders. Despite the advent of new AEDs, drug resistant-epilepsy continues to affect 30-40% of PWE. Once identified as having drug-resistant epilepsy, these patients should be referred to a comprehensive epilepsy center for evaluation to establish if they are candidates for potential curative surgeries. Unfortunately, a large proportion of patients with drug-resistant epilepsy are poor surgical candidates due to a seizure focus located in eloquent cortex, multifocal epilepsy or inability to identify the zone of ictal onset. An alternative treatment modality for these patients is neuromodulation. Here we present the evidence, indications and safety considerations for the neuromodulation therapies in vagal nerve stimulation (VNS), responsive neurostimulation (RNS), or deep brain stimulation (DBS).

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“…Although there has been steady progress with these strategies over the decades, many approaches are maturing to the point where they seem poised to provide a workable and effective therapy for a larger number of patients. 70 Indeed, the introduction in 2013 of an FDA-approved closed loop device that detects seizures and aborts them by deep brain stimulation has spawned many efforts to refine stimulation parameters for better seizure control. 71 New seizure prediction algorithms 8 as well as new devices may allow intravenous injection or even direct infusion of antiseizure agents into the brain at the onset of or immediately before a seizure is predicted.…”

Section: Real-time Management Of Seizuresmentioning

confidence: 99%

Epilepsy Benchmarks Area III: Improved Treatment Options for Controlling Seizures and Epilepsy-Related Conditions Without Side Effects

et al. 2020

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The goals of Epilepsy Benchmark Area III involve identifying areas that are ripe for progress in terms of controlling seizures and patient symptoms in light of the most recent advances in both basic and clinical research. These goals were developed with an emphasis on potential new therapeutic strategies that will reduce seizure burden and improve quality of life for patients with epilepsy. In particular, we continue to support the proposition that a better understanding of how seizures are initiated, propagated, and terminated in different forms of epilepsy is central to enabling new approaches to treatment, including pharmacological as well as surgical and device-oriented approaches. The stubbornly high rate of treatment-resistant epilepsy—one-third of patients—emphasizes the urgent need for new therapeutic strategies, including pharmacological, procedural, device linked, and genetic. The development of new approaches can be advanced by better animal models of seizure initiation that represent salient features of human epilepsy, as well as humanized models such as induced pluripotent stem cells and organoids. The rapid advances in genetic understanding of a subset of epilepsies provide a path to new and direct patient-relevant cellular and animal models, which could catalyze conceptualization of new treatments that may be broadly applicable across multiple forms of epilepsies beyond those arising from variation in a single gene. Remarkable advances in machine learning algorithms and miniaturization of devices and increases in computational power together provide an enhanced opportunity to detect and mitigate seizures in real time via devices that interrupt electrical activity directly or administer effective pharmaceuticals. Each of these potential areas for advance will be discussed in turn.

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Comparison and Selection of Current Implantable Anti-Epileptic Devices

Cited by 38 publications

References 98 publications

Evolution of the Vagus Nerve Stimulation (VNS) Therapy System Technology for Drug-Resistant Epilepsy

Evolution of the Vagus Nerve Stimulation (VNS) Therapy System Technology for Drug-Resistant Epilepsy

Neuromodulation in Drug Resistant Epilepsy

Epilepsy Benchmarks Area III: Improved Treatment Options for Controlling Seizures and Epilepsy-Related Conditions Without Side Effects

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