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Scrambler Therapy® device (international patent)

The Scrambler Therapy® Technology ST-5A is a patented non-invasive electro-analgesia device, with 5 channels that deliver low-intensity stimuli (max. 5 mA) generated by a completely automated treatment program. Five artificial neurons create "packets" (strings) of information recognized as "non pain", the content of which is controlled by a proprietary algorithm. This various information of "no pain" produces an immediate analgesic effect, capable of completely eliminating pain in real time. Up to 5 pairs of independent electrodes can be placed on the patient's body based on the need of the treatment. Two microprocessors ensure the correct operation of the device by automatically establishing the optimal parameters of effectiveness and safety, which cannot be modified by the operator. The placement of the electrodes requires scrupulous observance of the method of identifying the areas of pain treatment. If the treatment is performed correctly, normally the pain is zeroed (or reduced very close to zero) in real time regardless of the initial intensity and the pathology that generated it.

The Scrambler Therapy® device has been used to successfully treat thousands of patients worldwide, where it has been shown to be effective in treating neuropathic and oncologic pain. Scrambler Therapy is a stand-alone medical electroanalgesia device, and does not require combinations with other analgesic therapies.

This medical device (international patent) has been developed in Italy by Prof. Giuseppe Marineo .

Scrambler Therapy scientific and clinical research (International Patent) is currently available in just one medical device labelled Scrambler Therapy® Technology ST-5A.

This medical device replacing the previous first generation (known in the US as the Calmare® device) and the second generation (Scrambler Therapy® Technology MC-5A).

Indications for Use

Indications for Use FDA K201458
• Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain.
• Symptomatic relief of acute pain.
• Symptomatic relief of post-operative pain.

Indications for Use (MDR 745/2017)
The specific indications of use that derive from the scientific literature indexed and published in peer review scientific journals based exclusively on this technology, are:
• Symptomatic relief of chronic opioid-resistant pain.
• Symptomatic relief of chronic neuropathic and oncological pain. In general, this device is indicated for forms of severe chronic pain, in particular that which does not respond to other pharmacological and non-pharmacological treatments, including opioids. Scrambler Therapy® Technology Pain Therapy Treatment

Protocol
• The patient visits the practice for 10 to 12 consecutive treatments.
• One treatment per day over a period of two weeks.
• Treatment sessions may last from 30 to 45 minutes.
• Booster cycles are given when needed. This medical device has been designed to be used in hospitals and ambulatory care centers by specialized and trained medical personnel. This device is patent protected.

Clinical efficacy

Scrambler Therapy® if correctly used is a control tool for severe chronic neuropathic and cancer pain. Scrambler Therapy® is very effective, non-invasive and mainly to be used in ambulatory care and hospital facilities. If carried out correctly the analgesic effect during the treatment is very rapid. In just a couple of seconds the pain perception completely disappears. This is true even in cases where pain is of high intensity and non-responsive or poorly responsive to opioids or other electro-analgesia devices such as TENS or implanted devices.

Short- and long- term effects of a single treatment cycle depend on the type of pathology and other variables. In most cases of benign pain one treatment cycle is enough to produce pain relief for at least two months, but can even exceed 12 months if neuropathic damage is limited (mono-radicular) or the pathology has no evolution feature. Other variables that influence the treatment outcome are pharmaceutical interactions. Immediate analgesic efficacy during the treatment is a constant factor regardless of pathology and pain intensity.

For more information visit the Official Scrambler Therapy® scientific and clinical information website .

International distribution

DIS&L through its law firm is the only company authorized to sign international exclusive agreements in all international area , provide maintenance and distributor support for method usage training and other logistics needs. To request a national exclusive agreement the candidate distributor must have minimum requirements listed on the “ Distributor Requirement ” page.

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