Pain relief without drugs
An Interlochen couple believes their electronic pain-relieving device manufactured in the Greater Grand Rapids area could help reduce the need for opioid analgesics.
"There is a need for this. It fills the void for people looking for pain relief, without a high cost factor and without the side effects" of narcotics, said Paul Kasper, president of Alivio Corp.
Cindy and Paul Kasper started Alivio Corp. in Interlochen in 2001 and contracted with Petra Electronics Manufacturing in Moline to make their two medical devices: the Alivio IF4 and the Alivio STX. The IF4 is an interferential current stimulator and the STX is a neuromuscular stimulator. The devices are similar; both use electric current to stimulate nerve and muscle fibers, and they have been approved by the Food & Drug Administration.
"The Alivio IF4 is the only portable interferential stimulator on the market with an independent double-blind study supporting its efficacy," said Kasper. The study was done by the Kerlan-Jobe Orthopaedic Clinic in California and published in the January 2003 Clinical Journal of Sport Medicine. It concluded that home interferential current stimulation, or IFC, may help reduce pain in patients who have undergone knee surgery and may result in a quicker return to daily activities.
Electrotherapy isn't new: It is the electrical stimulation of the nervous system to block pain signals to the brain and to stimulate muscle and soft tissue to enhance healing, according to the Alivio Web site. Originally it was only used in a medical setting, but portable stimulators called TENS (transcutaneous electrical nerve stimulation) were in wide use for 20 or 30 years, according to Cindy Kasper.
The interferential and muscle stimulators are "newer generation and far more effective," she added.
The devices are only provided to patients by a doctor's prescription. Most of Alivio’s business is in renting the devices, which is generally covered by insurance and costs about $300 a month. A typical prescription is for three months. The IF4 interferential device, which is more powerful than the STX, costs about $2,100 to buy, while the STX is priced around $900.
The Kaspers were distributors of the devices 13 years ago, which were being manufactured in New Hampshire at that time under the brand name Stimtech. The portable devices were first developed in the 1970s by two inventors from Minnesota who had worked for several years at Medtronic Inc. in Minneapolis. They were familiar with the medical practice of surgically implanting electrodes in a spine to block pain signals to the brain, according to an article in The New York Times. The inventors developed electrodes in small spongy pads that were placed on certain areas of the body, without having to be implanted surgically.
The inventors started a company called Stimulation Technology Inc., or Stimtech for short, to manufacture their device, which they called a transcutaneous electrical nerve stimulator.
The product was a notable success. The New York Times article from 1981 mentions that a member of the Dallas Cowboys who was in pain from an injury wore a battery-operated Stimtech TENS to keep him in a game.
Soon Stimtech was bought by Johnson & Johnson — and later the inventors sued Johnson & Johnson, alleging that it had bought the innovative pain-killing device just to stifle it in order to protect its pharmaceutical business.
Like most electronic devices, TENS were soon being made overseas, and today, almost all of them used in the U.S. are foreign-made. But Paul Kasper said the imported stimulators are cheaply made, housed in a plastic case that is less durable than their metal case and less suited to serving as a rented device. Most of the imports are not digital, either, while theirs are. He said the IF4 has two microprocessors in it, and the STX has one.
"It's a specialized piece of equipment," he said.
"Our unit is truly portable," said Kasper, because it comes with a rechargeable nickel cadmium battery, while most others on the market use non-rechargeable batteries or need to plug into household current, which the Alivio products also can do.
"Because this device draws so much current, you're just going through nine volts (batteries) like crazy," he said.
Cindy Kasper said many people with chronic pain suffer adverse effects from taking narcotics and other strong medications. She said many of those people have found that using either of their devices, "especially the IF4, allows them to either discontinue the powerful medications or greatly reduce them. It’s a huge benefit to people that are trying to resume daily activities in their life but are so adversely affected by pain, or by narcotics that control the pain."
The original inventors of the TENS units discovered it also works on phantom limb pain, where an individual who has lost an arm or leg suffers discomfort or severe pain seemingly in the limb that is no longer there. The signals to the brain are carried by nerves that once connected to the missing limb.
"We've had several patients now who have treated phantom limb pain and gotten extremely good results, which is really wonderful for them because there is very little that has been effective for phantom limb pain," she said.
Paul and Cindy Kasper lived in California before they became involved in the medical device industry. A lawyer by profession, Paul had worked in investment banking and real estate development. When they returned to their native Michigan, they looked for a business to invest in that they could manage together.
The final assembly and shipping of their electronic stimulators is done at their small facility near Interlochen, which employs about five people.