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.