A clinical study of 30 patients found OrtoWell’s hydraulic vertebral distractor system was confirmed to be safe and effective, according to a Nov. 10 news release.
The study, published in Medical Devices: Evidence and Research in October, assessed the system’s use in patients treated in Germany from 2018 to 2023. There were no device-related complications, and surgeons reported consistent positive feedback on precision, stability and control.
“The data confirms what surgeons have long reported – that hydraulic distraction offers a gentler, more controllable approach to vertebral separation than mechanical systems,” Stan Mikulowski, CEO of OrtoWay-US, said in the release. “The OrtoWell distractor gives surgeons a new level of tactile precision, helping reduce procedural risk while improving predictability in spinal reconstruction. This is a key step to establishing a new future standard in spinal surgery.”
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