The Food and Drug Administration has provided 510(k) clearance for Prelivia, a neurostimulation device developed by Rehabtronics that promotes healthy blood circulation and maintains healthy tissue in people who are bedridden or chair bound.
More than 2.5 million people in the United States suffer from pressure ulcers annually and up to 60,000 people die from them.
“Every year, more people die from pressure injuries than from automobile accidents in the USA alone,” said David Armstrong, M.D., a professor of surgery at the University of Southern California and a wound care expert. “The potential promise of Prelivia to maximize ulcer-free, hospital-free and activity-rich days is enormously exciting.”
Current alternatives used to treat bed sores in long-term care centers include patient turning, sensors and specialty beds and mattresses, which provide only temporary relief, noted Rahul Samant, M.D., CEO of Rehabtronics.
“Due to COVID-19, even more patients are suffering from unavoidable pressure injuries and if it weren’t for the herculean efforts of nurses, the incidence of bedsores would be substantially higher than they are today,” Samant said. “Prelivia gives nurses a new tool to help protect their patients from pressure injuries.”
Prelivia uses a patented neurostimulation technology that activates local blood circulation. Studies show that the device’s unique technology increases tissue oxygenation by 28% and decreases 80% of pressure induced tissue damage. A caregiver applies electrodes to a patient’s skin in the area that is at-risk for developing a pressure injury. Once activated, they stimulate muscle contraction every 10 minutes, which maintains healthy blood flow.