The Food and Drug Administration has granted 501(k) clearance to Prelivia, a neurostimulation device to promote healthy blood circulation and maintain healthy tissue for individuals who are bedridden or chair bound.
Prelivia utilizes neurostimulation technology to prevent pressure injuries by activating muscle contraction and stimulating blood flow in ischemic areas. It stimulates muscle contraction every 10 minutes through electrodes that are applied onto the skin of the individual’s at-risk area. The electrodes are then activated with a wireless stimulator device. The device is painless and may be used continuously.
According to studies, Prelivia was found to increase tissue oxygenation by 28% and decrease pressure induced tissue damage by 80%. Prelivia was also recently tested on 68 patients who were considered at risk of developing a pressure ulcer or bed sore at a health care facility in Alberta, Canada. Findings showed that there were no pressure injuries observed during the 4-week period when Prelivia was applied.
“Prelivia offers a much-needed alternative to patients at risk for bed sores and their care givers who are required to turn patients every 2 hours to prevent these injuries,” said Dr Rahul Samant, CEO of Rehabtronics, which developed Prelivia. “[…] Prelivia gives nurses a new tool to help protect their patients from pressure injuries.”
FDA clears Prelivia, a medical device that protects patients from pressure injuries at hospitals and care homes. News release. Rehabtronics. Accessed September 1, 2021. https://www.prnewswire.com/news-releases/fda-clears-prelivia-a-medical-device-that-protects-patients-from-pressure-injuries-at-hospitals-and-care-homes-301366827.html.