Ivivi orthopedic health takes steps to rebrand.
"Amp Orthopedics reflects our company's strategy to bring critical change to the treatment paradigm for pain management in orthopedic indications by providing safer, more effective and non-narcotic treatments," Amp CEO Eric Dremel said.
Amp Orthopedics develops non-invasive products for the treatment of postoperative pain and edema. The products use a non-thermal pulsed radio frequency (PRF) technology to enhance the body's natural healing pathways and accelerate recovery from surgery. PRF induces a non-invasive pulsed magnetic field to accelerate the biochemical cascades involved in tissue repair and regeneration, according to the company. Pulsed magnetic field therapy has been used successfully to treat delayed union fractures, chronic wounds and post-operative pain and edema, Amp executives claim. It also is used to better manage symptoms of knee osteoarthritis.
Amp's PRF technology received CE Mark approval in the European Union in December 2007 for the promotion of wound healing, reduction of pain and treatment of post-operative edema. The U.S. Food and Drug Administration (FDA) gave its blessing to the technology the following year, endorsing the company's 510(k) application for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue.
Amp Orthopedics is a subsidiary of Ivivi Health Sciences LLC, a San Francisco, Calif.-based developer of inductive electrotherapy technology. Its signature product is the Ivivi Torino II, a portable, battery-operated non-invasive device that generates a targeted low-intensity time-variant electromagnetic field. This field, according to Ivivi, accelerates the body's natural anti-inflammatory activity and reduces the production of a key pro-inflammatory cytokine, IL-1[beta]. Use of the FDA-cleared Torino II can relieve pain and edema better than approved pain medications and non-steroidal anti-inflammatory drugs, executives claim.
Patients enrolled in a double-blind, placebo-controlled study several years ago used the Torino II to relieve osteoarthritis pain in their knees. Participants strapped the device to their knees twice a day for six weeks, allowing the product's low-intensity pulsating electromagnetic frequency to target the afflicted area for 15 minutes at a time. All patients given a working Torino II (as opposed to a placebo device) experienced a 40 percent reduction in pain on their first day.
In laboratory tests, electromagnetic signals have been used to decreased calcium in cartilage cells. This reduction, experts claim, triggers a series of chemical reactions that can help reduce inflammation.
Before its use in knee osteoarthritis clinical trials, electromagnetic fields have only been used to control pain resulting from cosmetic surgery, Ivivi executives said.
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|Title Annotation:||Industry News|
|Publication:||Orthopedic Design & Technology|
|Date:||Jan 1, 2012|
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