iovera system cleared for treating osteoarthritic knees
Myoscience has won FDA clearance for its iovera cryoneurolysis system to be used for symptom and pain relief in the knees arising from osteoarthritis. The company’s so-called Focused Cold Therapy delivery system pumps pressurised liquid nitrous oxide (N2O) to the treatment tip, where it is made to turn to a gas and become very cold. The phase change happens in tight location, creating a small and precise treatment area that can be used to create a nerve block that stops the transmission of pain.
Treatments are quite fast and result in nearly instantaneous pain reduction thanks to a disruption in the functionality of nerve axons. This happens without damaging the surrounding tissue that surrounds the nerves.
The FDA clearance was based on a recent prospective, multi-center, sham-controlled, randomised, double-blind study of 180 subjects. The study concluded that patients treated with the iovera device reported statistically significant greater reduction in pain and improvement in symptoms (p=0.001) when compared to patients who received the sham treatment(3). Also, patients who received the iovera° treatment reported pain relief lasting up to 90 days, accompanied by reduced stiffness and improved physical function.
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