Delta International
Service & Logistics receives FDA 510(k) Clearance for
Scrambler Therapy® MC-5A
ROME, June 15, 2015 /PRNewswire/ --
The FDA authorized the
marketing of the Scrambler Therapy® Technology MC-5A device. This
medical device has been developed in Italy for the treatment of
chronic neuropathic and oncologic pain resistant to opiates and
other types of treatment, replacing the previous version, known in
the US as the Calmare® device.
Scrambler Therapy®
Technology MC-5A development in the US
Delta International
Service & Logistics' main goal in the US is to create the
conditions to fully implement the methodology in line with the
original standards which are the only ones to guarantee a meaningful
increase of success rates in hospitals and independent clinical
trials. In the coming months this enterprise will create a series of
excellence centers to guarantee an optimal quality system for ST
usage including ST-NET support, a clinical "intelligent" network
based on a dedicated software designed exclusively for Scrambler
Therapy®. This software informs in real time the operator of
possible critical features, and suggests most fit treatment
protocols for any patient. In the future some of these centers will
be selected for the development of an adequate training and support
system to optimize the users' learning curve. These elements are
necessary to reduce to a minimum operator dependent bias, that as
recorded in statistical data from some independent clinical trials
is currently very high, and well beyond the norm.
About Delta
International Service & Logistics
DIS&L is an agency
created for the international development of Scrambler Therapy®
Technology MC-5A, and selecting of medical device distributors in
all international area. DIS&L through its law firm is the only
company authorized to sign international exclusive agreements,
provide maintenance and distributor support for method usage
training and other logistics needs.
About Scrambler
Therapy® Technology MC-5A
Scrambler Therapy®
scientific research and development technology have been developed
in Italy by Professor Giuseppe Marineo, who is the sole owner of its
intellectual property rights. The official "Scrambler Therapy"®
scientific and clinical information website is at
http://www.scramblertherapy.org/english.htm). FDA 510(k) Clearance:
# K142666, CE Certified: #CE 0470.
Contact U.S.
DIS&L Division:
Richard J. Erickson, North America Operations 6419
Hirondel St, Houston, TX 77087,406-249-0424
deltaintl3@gmail.com
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DIS&L. All rights reserved