Misgav, Israel-based OrthoSpin Ltd. has won FDA 510(k) clearance for AutoStrut, its automatically adjusted robot-assisted external ring fixation system for orthopedic treatments.
The use of external fixation, according to the company, is a common treatment option for orthopedic-related problems such as bone lengthening, setting complex fractures, and correcting deformities.
But there are challenges with that treatment option. The first is patient compliance. The second is a lack of real-time feedback for the physician. Patients have to make multiple manual adjustments every day which can lead to errors and less than optimal clinical outcomes.
AutoStrut eliminates the need for manual adjustment, said company CEO Oren Cohen, in a September 18, 2019 press release. This improves patient compliance and can result in less pain. "OrthoSpin’s system can monitor biomechanical parameters, and in the future will enable the device to automatically send real-time updates to physicians for following patient progress. This allows fine-tuning of the treatment regimen, if necessary, including a personalized treatment plan for each patient.”
According to the FDA clearance document, AutoStrut is comprised of six length-adjustable struts powered by a motor, a control system and software.
The system is indicated for the following treatments in adults, and in both children (3-12) and adolescents (12-21) in which growth plates have fused and will not be crossed with hardware:
The device is used in conjunction with the predicate DePuy Synthes MAXFRAME multi axial correction system, including all its parts and software but the MAXFRAME struts are substituted with the AutoStrut motorized struts.
The biggest difference from the predicate struts is that MAXFRAME struts are adjusted manually, while the AutoStrut struts are automatically adjusted via motorized control.
The predicate MAXFRAME was cleared with software that generates a treatment plan for the patient, detailing how much each strut should be extended after a given amount of time. The clearance documents state the output of this software is downloaded to the control box which will then automatically extend the motorized AutoStrut struts the predetermined amount at the prespecified times.
OrthoSpin, founded in December 2014 at Trendlines Incubators Israel, raised $3 million for the AutoStrut system in a July 2018 funding round led by Johnson & Johnson.
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