An electromagnetic navigation system for endoscopic minimally invasive spine surgery made by joimax, GmbH has been granted U.S. FDA 510(k) clearance.
FDA Clears Electromagnetic Navigation System for Spine Surgery
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Secondary#navigation#joimax#endoscopy
The Intracsem Navigation System reduces the need for intraoperative X-ray and radiation exposure. The system can be used with all joimax instruments and endoscopes to track and navigate through appropriate sensors. The system will allow for indication expansion, improved safety, and accelerated learning of endoscopic techniques.
Prof. Dr.med. Michael Kraus, a surgeon at ORTHIX Zentrum in Augsburg, Germany, headed the cadaver trials of Intracs and said of the system, “Using Intracsem Navigation System in the full endoscopic spine surgery is safe and easily applicable. The technology helps master precise access to the spine, and the clinical trials have confirmed the technique’s multiple advantages.”
Christoph Hofsetter, M.D., Ph.D., of the University of Washington Medical center added, “joimax Intracs constitutes a highly precise image-guided navigation platform designed for the specific needs of full-endoscopic spine surgery.”
“Using electromagnetic navigation technology allows us to track the leading edge of endoscopic instruments in real time, and facilitates needle targeting and orientation during the surgery, while minimizing radiation exposure. No doubt, this technology will expand the indications for full-endoscopic spine surgery and pave the way for innovations in minimally invasive arthrodesis techniques.”
In addition to the clearance, joimax recently announced a distribution partnership with Japan-based JMC-JAPAN MEDICALNEXT CO. LTD. that will enable joimax products to be sold on the Japanese market.
joimax Founder and CEO Wolfgang Ries said, “joimax® is looking forward to working with a partner as strong as JMC.” Ries’ compeer at JMC, Masayuki Yoshimura, is also excited about the partnership. “With our shared vision for advancing the field of minimum invasive spinal surgery, we are looking forward to introducing the globally recognized joimax products in Japan,” said Yoshimura. Endoscopic spine surgery is much more common in Asia than the U.S.
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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