General Info:
Sigmedics, Inc was founded to design, manufacture and market rehabilitation products for the neurologically impaired. The company's first product, which is called the Parastep I System, is a technological breakthrough for people who have sustained a spinal cord injury. The Parastep System is a functional electrical stimulation ( FES ) system that enables independent, unbraced ( at the knee and hip ) standing and short distance walking by upper-motor-neuron injured paraplegics and some quadriplegics. The technology embodied in the Parastep System has been under development since 1981. Sigmedics, Inc was formally incorporated in 1988, for the purpose of transferring this technology from the research laboratory to commercialization. The first application of FES to a paraplegic patient was reported by Kantrowitz in 1963. The quadriceps and glutei muscles of a paraplegic were stimulated using surface electrodes, and erect standing was achieved for a few minutes. Research conducted since then by several academic investigators has demonstrated that the application of electrical impulses of the appropriate amplitude, pulse width and frequency can enable paraplegics to stand and take steps. The Parastep System was developed by Sigmedics based upon the inventions of Dr. Daniel Graupe, Professor of Electrical Engineering and Computer Science and Adjunct Professor of Physical Medicine and Rehabilitation at the University of Illinois in Chicago. In 1981, after a decade of research on the control of prostheses and orthoses for independent use by paraplegics and amputees, Dr. Graupe, in conjunction with Kate Kohn, M.D., Clinical Professor at the University of Illinois Medical School, and Chairperson, Department of Physical Medicine and Rehabilitation, began patient trials with FES for standing and walking at Michael Reese Hospital and Medical Center in Chicago. The Parastep System is the result of ten years of their research with subjects at Michael Reese. As part of the technological transfer in 1988, Sigmedics conducted over an extended period of time multi-center clinical trials, following a Premarket Approval ( PMA ) application submission to the U.S. Food and Drug Administration ( FDA ), in 1990. The trials led to the approval ( # P900038 ) of the Parastep I System for commercial marketing as a Class III medical device, in 1994. As of April 1st., 2003, the Centers for Medicare and Medicaid Services ( CMS ) as well as certain other major insurance carriers announced that they will extend coverage for the purchase of the Parastep I System and for the costs associated with the required physical therapy gait training and instruction in system use, for qualified beneficiaries and clients. Specific HCPCS codes have been assigned by CMS for billing for the PT services ( Gait Training Code # 97116 ), as well as for the durable medical equipment ( DME ) ( Code # K0600 ). Medicare will be covering approximately 80% of system acquisition costs.