Auctus Surgical, a San Francisco-based company devoted to non-fusion options for scoliosis patients, announced that the FDA has granted Breakthrough Device Designation for the company’s novel vertebral body tethering (VBT) system. The system is a non-fusion, dynamic approach dynamic treatment for pediatric scoliosis.
New Patent/Breakthrough Status for Auctus’ Vertebral Tethering
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Auctus Surgical’s VBT system was one of Orthopedic This Week’s Best Technology in Spine award winner in 2020.
The FDA’s breakthrough designation is a recognition that the Auctus dynamic VBT system is unique and will meet a clear clinical need; it also allows for priority review and interactive communication regarding device development.
Auctus also announced that the United States Patent and Trademark Office has issued the company a new patent for “spinal curvature modulation systems and methods,” which covers the specific technologies and methods of the Auctus System.
With only one necessary treatment event, the Auctus VBT system offers surgeons and their adolescent patients an option to complex fusion surgery.
Auctus CEO and Founder John Barrett described to OTW how the system works. “The Auctus system employs a magnetically driven tensioning system that is actuated non-surgically via an external magnetic controller, giving the surgeon total control of straightening the curved spine without breaking the skin. Once a spine is straight, the tether can be released, resulting in continued growth potential and motion preservation for life.”
“These back-to-back achievements continue the momentum in the development of this critical therapy,” states Barrett. “I am proud of the tremendous efforts put forth by our team—efforts that will make a concrete difference in the lives of suffering adolescents and their families.”
“Spinal fusion for scoliosis is a century old operation that corrects deformity but eliminates movement of the spine,” states Mohammad Diab, M.D., professor and vice chair in the Department of Orthopaedic Surgery and the Department of Pediatrics at the University of California San Francisco. “The pediatric surgical community, as well as our patients, are eager for and welcoming of a fusionless option for the treatment of scoliosis. The Auctus Dynamic Tethering System will do just that and will do so in a modular manner that allows greater control of the spine.”
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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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