Journal: Neuromodulation : journal of the International Neuromodulation Society
Article Title: Public Regulatory Databases as a Source of Insight for Neuromodulation Devices Stimulation Parameters
doi: 10.1111/ner.12641
Figure Lengend Snippet: Charge and charge density per phase for neuromodulation devices available from public regulatory databases. Charge and charge density information for approved medical devices obtained from public databases plotted along data from McCreery et al. (9,10) for experiments with acute stimulation in feline cortex. Open rectangles symbols correspond to experiments where no tissue damage was observed. Filled black symbols correspond to data points where tissue damage was observed. Medtronic Activa Summary of Safety and Effectiveness Data (SSED) provides details of an acute stimulation study in pigs with deep brain stimulation leads. For stimulation with k-values from 3.18 to 4.47, mechanical damage could not be reliably distinguished from electrical damage (gray filled circles). The EnteroMedics Maestro SSED for peripheral nerve stimulation (PNS) describes a study in pigs where nerve degeneration was observed after neurostimulation with k =0.58, but according to the summary, it originates from mechanical strain (gray filled stars). The SSED for Nevro Corp Senza spinal cord stimulator (SCS) has details for a study in goats with stimulation at k below zero when no signs of damage were observed (gray filled diamonds). Five 510(k) summaries for SCS devices document that Medtronic Xtrel and Mattrix were cleared to operate with k of 3.23 and 2.99; Renew from ANS was cleared for k of 2.65; Freedom SCSs from Stimwave were cleared for k of 2.61 (2014) and 2.51 (2015) (filled blue semitransparent hexagons, diamonds, circles, triangles and inverted triangles, respectively). It is important to stress that SCSs do not operate in Shannon “near-field” scenario. [Color figure can be viewed at wileyonlinelibrary.com]
Article Snippet: The following devices were included: Renew Neurostimulation System with Quattrode Lead Kit from Advanced Neuromodulation Systems Inc, K000852 ( 46 , 47 ); Freedom Spinal Cord Stimulator (SCS) System from Stimwave Technologies Inc, K141399 ( 47 ) and K150517 ( 48 ); Medtronic Mattrix, K934065 ( 47 , 49 ); and Medtronic Xtrel, K883780 ( 47 , 50 ) ( and ). table ft1 table-wrap mode="anchored" t5 caption a7 Device 510(k) Control f , Hz P.W., ms A , cm 2 Q max @500 Ω, μC D max @500 Ω, μC·cm −2 Xtrel (Medtronic) K883780 Voltage 5–1400 0.05–1 0.1225 14.2 118.3 Mattrix (Medtronic) K934065 Voltage 5–240 0.05–0.5 0.1225 10.8 90 Renew (ANS) K000852 Current 10–1500 0.05–0.5 0.13* 7.6 58.5 Freedom (2014, Stimwave) K141399 Current 2–1500 0.05–0.5 0.1272 7.2 56.6 Freedom (2015, Stimwave) K150517 Current 5–1500 0.05–0.5 0.1272 6.4 50.3 Open in a separate window 510(k), 510(k) submission number, f , stimulation frequency (Hz); Control, current or voltage control; P.W., pulse width (millisecond); A , electrode area; Q max @500 Ω, μC; and D max @500 Ω, μC·cm −2 , maximum charge per phase and charge density per phase calculated from device stimulation parameters listed in summaries (assuming 500 Ohm load for voltage controlled stimulation).
Techniques:
![Charge and charge density per phase for neuromodulation devices available from public regulatory databases. Charge and charge density information for approved medical devices obtained from public databases plotted along data from McCreery et al. (9,10) for experiments with acute stimulation in feline cortex. Open rectangles symbols correspond to experiments where no tissue damage was observed. Filled black symbols correspond to data points where tissue damage was observed. Medtronic Activa Summary of Safety and Effectiveness Data (SSED) provides details of an acute stimulation study in pigs with deep brain stimulation leads. For stimulation with k-values from 3.18 to 4.47, mechanical damage could not be reliably distinguished from electrical damage (gray filled circles). The EnteroMedics Maestro SSED for peripheral nerve stimulation (PNS) describes a study in pigs where nerve degeneration was observed after neurostimulation with k =0.58, but according to the summary, it originates from mechanical strain (gray filled stars). The SSED for Nevro Corp Senza spinal cord stimulator (SCS) has details for a study in goats with stimulation at k below zero when no signs of damage were observed (gray filled diamonds). Five 510(k) summaries for SCS devices document that Medtronic Xtrel and Mattrix were cleared to operate with k of 3.23 and 2.99; Renew from ANS was cleared for k of 2.65; Freedom SCSs from Stimwave were cleared for k of 2.61 (2014) and 2.51 (2015) (filled blue semitransparent hexagons, diamonds, circles, triangles and inverted triangles, respectively). It is important to stress that SCSs do not operate in Shannon “near-field” scenario. [Color figure can be viewed at wileyonlinelibrary.com]](https://pub-med-central-images-cdn.bioz.com/pub_med_central_ids_ending_with_1129/pmc05801129/pmc05801129__nihms907582f2.jpg)