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Trial compares the effect of cryoanalgesia using the iovera° system to the standard of care for managing pain after TKA.
December 18, 2018
By: Myoscience Inc.
Myoscience Inc. has completed enrollment in its randomized, controlled trial at the Campbell Clinic in Memphis, Tenn. This study enrolled 125 patients and compares the effect of cryoanalgesia using the iovera° system to the standard of care for managing pain after total knee replacement surgery (TKA). The Myoscience iovera° system is currently being used to treat chronic and perioperative knee pain. The Campbell Clinic study will demonstrate how cryoanalgesia can significantly reduce opioid consumption after TKA, and lead to improved physical function and enhanced recovery. Analysis of interim data confirms that cryoanalgesia with the iovera° system can be a preferred treatment for relieving postoperative TKA pain. “I am very impressed with the results of this prospective randomized study thus far. The positive effect of the iovera° system has exceeded our original expectations”, stated William Mihalko, M.D., principal investigator for this study. “Having a technology as effective as this to combat excessive opioid use after primary TKA can be a game changer for many patients. Many of us will adopt the use of the technology on a regular basis at my institution.” Timothy I. Still, president and CEO of Myoscience stated, “I share Dr. Mihalko’s enthusiasm about iovera°. We look forward to sharing these interim results.” Silicon Valley, California-based Myoscience is a privately-held medical device company committed to making its platform technology, the iovera° system, the standard of care for the treatment of peripheral nerves. The iovera° treatment is powered by a patented device that enables cryoneurolysis. The ioveraº system is 510(k)-cleared by the U.S. Food and Drug Administration for the blocking of pain, the relief of pain and symptoms associated with osteoarthritis of the knee for up to 90 days and general surgical use.
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