FDA grants breakthrough designation for VBT scoliosis system

The FDA has granted breakthrough designation for Auctus Surgical’s vertebral body tethering scoliosis treatment.

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Auctus Surgical’s VBT system has a non-fusion approach and provides a viable, flexible option to complex fusion surgery, according to an Aug. 11 news release. Auctus’ system utilizes an external magnet controller for non-surgical adjustment of the spine over time.

Breakthrough designation will allow for priority review and interactive communication with a device’s development.

The company also received a U.S. patent for the system.

At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.

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Presenters: Joe Ganley, athenahealthJeffrey Flynn, CASC, Gramercy Surgery CenterBryan Tsao, Access Center, Loma Linda University HealthJason Zepeda, Northridge Hospital Medical Center, CommonSpirit HealthGreg DeConciliis, PA-C, CASC, Boston Out­Patient Surgical Suites

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