cva stroke 2011
DESCRIPTION
Stroke Presentation 2011TRANSCRIPT
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• 10 year old medical device company10 year old medical device company• Atlanta ,Ga. and manufacturing in Modesto, Ca.Atlanta ,Ga. and manufacturing in Modesto, Ca. Shenzhen, ChinaShenzhen, China• FDA - seven 510ks, 8 medical claims, CE MarkFDA - seven 510ks, 8 medical claims, CE Mark• CMS Codes, Medicare ReimbursementCMS Codes, Medicare Reimbursement• In the market having treated > 200,000 patientsIn the market having treated > 200,000 patients• 8 published clinical studies with several pending8 published clinical studies with several pending• FDA/GMP and ISO13485/2003FDA/GMP and ISO13485/2003• Distribution agreements for Japan and GermanyDistribution agreements for Japan and Germany
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• WorldWorld’’s 1s 1stst Garment Electrodes Garment Electrodes • Wearable / PC interactive StimulatorWearable / PC interactive Stimulator
• Nocturnal Stimulation: Nocturnal Stimulation:
““Therapy While SleepingTherapy While Sleeping””
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Delivers electro-therapy * uniform therapy over the treatment area
Conductivity remains stable for 90 days
Soft, comfortable, washable
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Micro-current HVPG• 40 years of clinical use• > 100 Citations• 17 RCT Studies; n= 817• Meta analysis of 95%• HHS endorsed• CMS endorsed• 4 Prizm Clinical Studies
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49 year old patient 10 months after spinal cord injury
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“ Daily Electro-Mesh™ Glove stimulation can modify altered motor control and improve voluntary wrist extension movement in stroke subjects with chronic neurological deficits.”
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S. Golaszewski,et.al.
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“…change occurred in a definite pattern in the region of the regional cerebral blood flow of the brain cortex after mesh glove whole hand stimulation…‑ ”
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Modulatory effects on humansensorimotor cortex by whole-handafferent electrical stimulationS.M. Golaszewski, MD;
Conclusions: “The increased BOLD response spatially localized within the sensorimotor cortex reflects an increase in neuronal activity that may provide augmented neuronal excitability”.
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Cutaneous electrical stimulation may enhancesensorimotor recovery in chronic strokeSH Peurala, K Pitkänen, J Sivenius and IM Tarkka Brain Research and Rehabilitation Center Neuron, Kuopio, Finland
•Subthreshold sensory stimulation improve limb function late after stroke.• It may also alter central responsiveness to sensory stimulation, altering somatosensory evoked potential.• These changes followed only brief treatments, 20 min. twice daily over three weeks
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Therapy while Sleeping
“Serving patients with therapeutic energy ”