With medical device companies across the nation hustling to find ways to treat pain without addictive opioid drugs, Medtronic is launching a system called the Intellis that uses electricity and can be securely controlled with a Samsung tablet.
The Intellis is a latest-generation spinal-cord stimulation system that uses electric pulses to prevent pain signals from reaching the brain. The system was designed with features that address issues with older devices, including a new design that allows patients to fully recharge the device battery in one hour, and an interface that lets a doctor use a Samsung Galaxy S2 tablet to quickly adjust device settings and view past performance.
"The Intellis platform was designed based on what is most important to patients and physicians," Dr. Marshall Stanton, president of Medtronic's pain therapies division, said in a news release.
More than 20,000 Americans a year die from overdoses of prescription pain drugs, a toll that has shifted public attention toward ways of treating pain without creating addiction. Last May, Food and Drug Administration Commissioner Dr. Scott Gottlieb wrote online that his highest priority is to take immediate steps to reduce the scope of the opioid addiction epidemic.
Implanted medical devices offer some promise in that regard, and a potentially large commercial market, but pain-relief devices also have their own drawbacks, including the need to charge batteries and the difficulty in adjusting device settings in response to subjective pain sensations.
Medtronic competitor Abbott Laboratories, which acquired Minnesota-based St. Jude Medical and its line of devices to treat chronic pain in January, has worked to churn out its own new devices with novel features to treat pain without opioid drugs.
"Spinal cord stimulation offers chronic pain patients a meaningful alternative to opioids, and our market leadership position is a direct result of Abbott offering patients two superior options not offered by competitors, including BurstDR stimulation for chronic back pain and Dorsal Root Ganglion stimulation for chronic focal pain," Abbott spokesman Justin Paquette wrote on Monday.
The latest Abbott devices use controllers made by Apple, and in addition to a rechargeable battery, Abbott offers a non-rechargeable primary-cell that "eliminates the recharge burden on patients," he said.
Boston Scientific, which employs thousands of Minnesotans, has a line of devices to treat pain as well.
"The entire field is growing," Boston Scientific CEO Mike Mahoney said in an interview last year. "Ideally, us, Medtronic, St. Jude all offer products there. The opioid epidemic's a big deal. And clearly we like our product position. But, even with competitors, it is an important societal problem that these spinal cord stimulators help with. … We could all agree that it's a problem and we're trying to help it."
Medtronic's updated Intellis system was approved in July via a supplement to the original FDA premarket approval application.
Indicated for treatment of chronic intractable pain, the Intellis system includes an implantable pulse generator that looks like an older-style pacemaker, but with wires called leads that deliver mild current to the epidural space in a spinal vertebra. The system includes a feature that standardizes suggested medical guidance and balances high-dose and low-dose settings. The system also can track a person's physical activity and can be managed from the Galaxy tablet.
Other companies in Minnesota that are making devices include AtriCure and Smiths Medical, which are taking part in a legislative roundtable in St. Paul spotlighting pain-management technology developed in the state.
The session is being organized by Golden Valley-based trade group the Medical Alley Association.
"As Minnesota and the nation tackles the opioid crisis, one significant part of the conversation we are not having is on pain management and specifically, alternatives that can be utilized to ensure that a patient never even is exposed to an addictive opioid," the trade group wrote in an introduction to the Oct. 2 meeting.