SLEEP 2014 Final Program - page 13

TheRelaxis™Pad, developedby SensoryMedical, is the first non-pharmacological medical device for
patients suffering loss of sleep due to primary RLS. Our FDA cleared device uses vibratory
counterstimulation to provide external stimulus to the affected area, which has been clinically proven to
relieveRLS symptoms and allow patients to quickly return to sleepwithout having to get out of bed.
A First-In-Class Device
TheRelaxis™Pad is the first prescriptiondevice cleared by the FDA to improve the quality
of sleep in patients with primary RLS through the use of vibratory counterstimulation.
Clinical Studies
SensoryMedical performed two randomized, multi-center, controlled clinical trials to assess the safety
and effectiveness of vibratory counterstimulation in the treatment of patients withprimary RLS.
Patient inclusion criteria (moderate to severeRLS) as well as primary and secondary endpoints, as
measuredwith standardized outcome instruments, were identical for both studies.
Publications
Analysis of the clinical studies, including four published peer-reviewed articles,
can found on our web site at:
.
Stop by Booth 1018 for more info and a product demonstration.
Introducing theFirst FDAClearedDevice
forPatientsSufferingLossofSleepDue
toPrimaryRestlessLegsSyndrome.
INDICATIONSFORUSE:
Thepurposeof theRelaxis™Pad is to improve thequality of sleep inpatientswithprimaryRestless LegsSyndrome (RLS) through theuseof vibratory counterstimulation.
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