Rechargeable Internal Neural Stimulators—Is There a Problem with Efficacy?

Harries, Anwen M.; Major, S.G.; Sandhu, Mandeep Singh; Honey, Christopher R.

doi:10.1111/j.1525-1403.2011.00406.x

Cited by 18 publications

(29 citation statements)

References 12 publications

(14 reference statements)

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“…The limitations of the study include that this was not a randomized trial and there was no placebo group. However, the InSite study showed SNM efficacy was similar at 6‐months, 1‐year, and 5‐years post‐implant . suggesting there is no significant placebo effect for SNM therapy by 6‐months.…”

Section: Discussionmentioning

confidence: 96%

“…While this is the first rechargeable SNM system to conduct a clinical study, the advantages of rechargeable neuromodulation systems are well established with rechargeable spinal cord stimulation and deep brain stimulation systems. These studies have shown high satisfaction with rechargeable neuromodulation systems, including 85‐90% of patients preferring or recommending rechargeable devices …”

Section: Discussionmentioning

confidence: 99%

“…These studies have shown high satisfaction with rechargeable neuromodulation systems, including 85-90% of patients preferring or recommending rechargeable devices. [17][18][19] An important advantage of rechargeable neuromodulation is the cost-effectiveness compared to non-rechargeable therapy. Noblett et al constructed a cost-consequence model and demonstrated that, over a 15-year horizon, adoption of a rechargeable device strategy was projected to save the U.S. healthcare system up to 12 billion USD.…”

Section: Discussionmentioning

confidence: 99%

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A prospective, multicenter study of a novel, miniaturized rechargeable sacral neuromodulation system: 12‐month results from the RELAX‐OAB study

Blok

Kerrebroeck

Wachter

et al. 2018

Neurourology and Urodynamics

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Aims Historically, providing SNM therapy required use of a non‐rechargeable implantable pulse generator (IPG) with an average device lifespan of 4.4 years. Multiple device replacement surgeries are necessary with this device for long‐term overactive bladder (OAB) management. A longer‐lived device can reduce and potentially eliminate the need for replacement surgeries, thereby improving the long‐term safety and cost‐effectiveness of SNM therapy. The objective of this study was to evaluate the safety and efficacy of a miniaturized, rechargeable SNM system. Methods This prospective, multi‐center study implanted 51 subjects with the SNM system in a single stage procedure without an external trial period. Subjects had overactive bladder as demonstrated on a 3‐day voiding diary (≥8 voids/day and/or ≥2 incontinence episodes over 72‐h). Outcome measures at 1‐year follow‐up included quality of life (evaluated by ICIQ‐OABqol questionnaire), therapy responder rates (≥50% reduction in voids and/or leaks or <8 voids per day), subject satisfaction questionnaire, and adverse events (AEs). Results At 1‐year, 94% of Test Responders continued to respond to r‐SNM therapy based on bladder diary criteria. Subjects experienced significant improvement of 21.1 points on the ICIQ‐OABqol. 84% of subjects were satisfied with r‐SNM therapy and 98% found their charging experience acceptable. Device‐related AEs occurred in 21% of subjects, with discomfort due to stimulation occurring in 20% of subjects. This AE was resolved with reprogramming in all instances. Conclusions The Axonics r‐SNM System provides sustained clinically significant improvements in OAB subjects after 1‐year. Subjects were satisfied with r‐SNM therapy and reported an easy and acceptable recharging experience.

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Section: Discussionmentioning

confidence: 96%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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A prospective, multicenter study of a novel, miniaturized rechargeable sacral neuromodulation system: 12‐month results from the RELAX‐OAB study

Blok

Kerrebroeck

Wachter

et al. 2018

Neurourology and Urodynamics

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“…Depending on the stimulation parameters, the procedure of charging the battery must, with the current technology, be undertaken daily or a few times a week, in comparison to physically exchanging the pulse generator, a replacement made on average every 3 to 5 years (Timmermann et al 2013) Some patients stated that this—sometimes daily—routine acted as a constant reminder of the underlying disease or disorder. As a result, they ended up identifying themselves more with their disease or disorder in comparison to their prior experience with non-rechargeable batteries (Harries et al 2012). Here, an intended improvement for the users created a concern that, from a narrative perspective, could be understood as a problem regarding an experienced loss in authenticity in terms of expressing that they felt less like themselves, and more like someone being impaired, more like a patient than a person.…”

Section: Case: Authenticitymentioning

confidence: 99%

Thinking Ahead on Deep Brain Stimulation: An Analysis of the Ethical Implications of a Developing Technology

et al. 2014

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Deep brain stimulation (DBS) is a developing technology. New generations of DBS technology are already in the pipeline, yet this particular fact has been largely ignored among ethicists interested in DBS. Focusing only on ethical concerns raised by the current DBS technology is, albeit necessary, not sufficient. Since current bioethical concerns raised by a specific technology could be quite different from the concerns it will raise a couple of years ahead, an ethical analysis should be sensitive to such alterations, or it could end up with results that soon become dated. The goal of this analysis is to address these changing bioethical concerns, to think ahead on upcoming and future DBS concerns both in terms of a changing technology and changing moral attitudes. By employing the distinction between inherent and noninherent bioethical concerns we identify and make explicit the particular limits and potentials for change within each category, respectively, including how present and upcoming bioethical concerns regarding DBS emerge and become obsolete. Many of the currently identified ethical problems with DBS, such as stimulation-induced mania, are a result of suboptimal technology. These challenges could be addressed by technical advances, while for instance perceptions of an altered body image caused by the mere awareness of having an implant may not. Other concerns will not emerge until the technology has become sophisticated enough for new uses to be realized, such as concerns on DBS for enhancement purposes. As a part of the present analysis, concerns regarding authenticity are used as an example.

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“…Rechargeable IPGs, which have longer predicted battery lives, are an alternative to primary-cell devices. In some cohorts, a majority of the patients were highly satisfied with the rechargeable stimulators (McAuley et al, 2013, Timmermann et al, 2013, Waln and Jimenez-Shahed, 2014); whereas in other cohorts, some patients felt that the burden of recharging was not worth the extra battery life (Harries et al, 2012, Lam and Rosenow, 2010). Whether a patient prefers a primary-cell or rechargeable IPG, improved efficiency can impact the cost and acceptability of DBS.…”

Section: Introductionmentioning

confidence: 99%

Design andin vivoevaluation of more efficient and selective deep brain stimulation electrodes

2015

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Objective Deep brain stimulation (DBS) is an effective treatment for movement disorders and a promising therapy for treating epilepsy and psychiatric disorders. Despite its clinical success, the efficiency and selectivity of DBS can be improved. Our objective was to design electrode geometries that increased the efficiency and selectivity of DBS. Approach We coupled computational models of electrodes in brain tissue with cable models of axons of passage (AOPs), terminating axons (TAs), and local neurons (LNs); we used engineering optimization to design electrodes for stimulating these neural elements; and the model predictions were tested in vivo. Main results Compared with the standard electrode used in the Medtronic Model 3387 and 3389 arrays, model-optimized electrodes consumed 45–84 % less power. Similar gains in selectivity were evident with the optimized electrodes: 50 % of parallel AOPs could be activated while reducing activation of perpendicular AOPs from 44–48 % with the standard electrode to 0–14 % with bipolar designs; 50 % of perpendicular AOPs could be activated while reducing activation of parallel AOPs from 53–55 % with the standard electrode to 1–5 % with an array of cathodes; and, 50 % of TAs could be activated while reducing activation of AOPs from 43–100 % with the standard electrode to 2–15 % with a distal anode. In vivo, both the geometry and polarity of the electrode had a profound impact on the efficiency and selectivity of stimulation. Significance Model-based design is a powerful tool that can be used to improve the efficiency and selectivity of DBS electrodes.

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Rechargeable Internal Neural Stimulators—Is There a Problem with Efficacy?

Cited by 18 publications

References 12 publications

A prospective, multicenter study of a novel, miniaturized rechargeable sacral neuromodulation system: 12‐month results from the RELAX‐OAB study

A prospective, multicenter study of a novel, miniaturized rechargeable sacral neuromodulation system: 12‐month results from the RELAX‐OAB study

Thinking Ahead on Deep Brain Stimulation: An Analysis of the Ethical Implications of a Developing Technology

Design andin vivoevaluation of more efficient and selective deep brain stimulation electrodes

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