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IVVI 1.91,
-0.11,
-5.4%) is a leader in
non-invasive, electroceutical(r) therapy systems designed to target
and enhance the body's anti-inflammatory response.
"The post operative pain often experienced after
breast augmentation surgery is currently treated with analgesics or
narcotics, which can have a serious side effect profile," commented
Dr. Per Heden, Associate Professor in Plastic Surgery at
Akademiklinken, in Stockholm, Sweden, and lead study author.
"Identifying innovative technologies for improving postoperative
comfort is important for all types of surgical procedures, including
breast augmentation, and PEMF was shown to be extremely effective in
reducing pain, and therefore reducing pain medication use. In the
treated group, PEMF therapy caused a significant decrease in pain of
approximately 2.7 times, or 87%, which persisted throughout the
study, with a 2.9 times decrease in use of pain medication."
"This study reinforces our clinical data that shows
the ability of our technology to enhance post-surgical pain
management," commented Steven Gluckstern, Chairman of Ivivi
Technologies. "Since the publication of the American Heart
Association Guidelines urging restricted use of non-steroidal
anti-inflammatory drugs (NSAIDs), the need for non-pharmacological
pain control has become critical for a large population of patients.
Our technology is cost effective, user friendly and has an excellent
safety profile -- important factors in patient acceptance. We also
believe with regard to elective aesthetic procedures like breast
augmentation surgery, the accelerated pain relief and
anti-inflammatory effects of our targeted PEMF signals could help
these patients return to their activities more quickly as well."
About the Study
In a randomized double-blind, placebo-controlled
pilot study of 40 healthy women undergoing breast augmentation
surgery with silicon breast implants, 12 received bilateral PEMF
therapy (a coil delivered PEMF signal for each breast); 14 received
sham therapy (neither coil delivered signal); and 14 received
contralateral therapy (each patient had one active and one sham
treatment in each breast). For each patient, two battery powered
coils (either delivering PEMF signals or no signal) were placed
inside compression bras. Once activated, the PEMF device
automatically provided a 30 minute treatment on a regular schedule
for eight days. Sham devices operated on the same schedule, but
delivered no signal. Pain data was measured using a Visual Analog
Scale (VAS) from 1-100, which was recorded by each patient twice
daily throughout the study. Patients were asked to rate their pain
for each breast. Post operative pain medication use was also
monitored for each patient.
The mean starting VAS score for all breasts in all
cohorts directly after surgery was approximately 53. By 3 days after
surgery (POD3), pain had decreased in the treated group (whether
bilateral or contralateral) to approximately 28.5 on the VAS scale,
versus approximately 40.2 for the sham group. There was little
difference between pain measurements for patients receiving
treatment in both breasts and those receiving it in one breast only.
Researchers in the study theorize that this is because the sham coil
may have captured up to 60% of the signal from the treated breast.
For the data analysis, the cumulative, daily pain measurements were
plotted for each group, and the slope of the group receiving
treatment was compared to that of the placebo group. Mean daily
cumulative pain measurements in patients receiving therapy decreased
approximately 87% faster than those in the placebo group (p less
than .001). Pill count for all patients in the study started out the
same, but decreased in the active cohort from approximately 6.2
pills to 3.1 by POD 3, and to 4.9 for the sham group.
Dr. Arthur Pilla, Professor of Biomedical Engineering
at Columbia University and Chair of the Ivivi Scientific Advisory
Board was a co-author on the study and is a paid consultant to the
Company.
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