The FDA has given 510(k) approval to Competitive Technologies, Inc. (Fairfield, CT) to market a pain management device for cases that are not sufficiently responding to drugs and other therapies. The company says its electromedical system sends electronic scrambling messages to the central nervous system, and effectively tricks the body to believe that all is well.
From the product, described as a “transcutaneous electrical modulation pain reprocessor”:
The pain management therapy technology is a non-invasive method for rapid treatment of high-intensity oncologic, neuropathic, and drug-resistant pain through a biophysical rather than a biochemical manner. The method incorporates electromedical equipment for electronic nerve stimulation, and uses the nerve fiber as a passive means to convey a message of normality to the central nervous system (CNS) by a procedure defined as scrambling or tricking of information, which then enables the CNS to modify the reflex adaptive responses — referred to as TEMPR — Transcutaneous Electrical Modulation Pain Reprocessor. It has been successfully used to treat over 2,300 patients in hospitals in Italy.
The non-invasive MC-5A device, using Scrambler technology, is a multiprocessor apparatus able to simultaneously treat multiple pain areas in the individual. The patient experiences longer "no pain" periods after each successive treatment.
The global pain management market is estimated to reach $40 billion by 2010. Potential market opportunities include hospitals, nursing homes and hospices, cancer treatment centers, and pain management centers.
Product page: Pain Management Therapy…
Press release: Competitive Technologies Receives FDA Authorization for Sales of Pain Therapy Medical Device …
Link to interview with Competitive Technologies CEO about the approval…